6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05094011 (ClinicalTrials.gov) | March 1, 2023 | 20/7/2021 | Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease | A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Biological: Aadipose-Derived Mesenchymal Stem Cells | Taiwan Mitochondrion Applied Technology Co., Ltd. | NULL | Not yet recruiting | 45 Years | 70 Years | All | 9 | Phase 1 | NULL |
| 2 | NCT05766813 (ClinicalTrials.gov) | March 2023 | 24/2/2023 | Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease | Parkinson Disease | Drug: Lenrispodun;Drug: Placebo | Intra-Cellular Therapies, Inc. | NULL | Recruiting | 40 Years | 80 Years | All | 132 | Phase 2 | United States |
| 3 | NCT05611372 (ClinicalTrials.gov) | January 1, 2023 | 6/11/2022 | Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease | Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease | REM Sleep Behavior Disorder;Parkinson Disease;Synucleinopathies | Drug: Rasagiline | Second Affiliated Hospital, School of Medicine, Zhejiang University | Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;West China Hospital;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong University;Fujian Medical University Union Hospital | Not yet recruiting | 30 Years | 75 Years | All | 732 | Phase 2/Phase 3 | NULL |
| 4 | NCT05610189 (ClinicalTrials.gov) | December 15, 2022 | 2/11/2022 | Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease | A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets | Parkinson Disease | Drug: Tavapadon | Cerevel Therapeutics, LLC | NULL | Recruiting | 45 Years | 80 Years | All | 24 | Phase 1 | United States |
| 5 | EUCTR2021-004849-20-AT (EUCTR) | 13/12/2022 | 05/08/2022 | A Study to Assess the Safety of BIIB122 Tablets and if it can Slow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB122 Product Code: DNL151, DN0001575, DN1575 INN or Proposed INN: NA Other descriptive name: DNL151, DN0001575, DN1575 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 640 | Phase 2 | United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Poland;Netherlands;Germany;China;Japan | ||
| 6 | NCT05642442 (ClinicalTrials.gov) | December 1, 2022 | 30/11/2022 | A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease | A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants With Parkinson's Disease | Parkinson Disease;Tremor | Drug: Placebo;Drug: Suvecaltamide | Jazz Pharmaceuticals | NULL | Recruiting | 40 Years | 80 Years | All | 160 | Phase 2 | United States |
| 7 | NCT05635409 (ClinicalTrials.gov) | November 30, 2022 | 15/11/2021 | A Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease | STEM-PD Trial: A Multicentre, Single Arm, First in Human, Dose-escalation Trial, Investigating the Safety and Tolerability of Intraputamenal Transplantation of Human Embryonic Stem Cell Derived Dopaminergic Cells for Parkinson's Disease (STEM-PD Product) | Parkinson Disease | Biological: STEM-PD | Region Skane | Lund University;Cambridge University Hospitals NHS Foundation Trust;University of Cambridge | Recruiting | 50 Years | 75 Years | All | 8 | Phase 1 | Sweden;United Kingdom |
| 8 | NCT05581823 (ClinicalTrials.gov) | October 19, 2022 | 12/10/2022 | Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants | A Phase 1, Open-label, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants | Parkinson Disease | Drug: Tavapadon;Drug: Carbamazepine | Cerevel Therapeutics, LLC | NULL | Active, not recruiting | 18 Years | 55 Years | All | 16 | Phase 1 | United States |
| 9 | NCT05635461 (ClinicalTrials.gov) | October 9, 2022 | 7/11/2022 | Relative Bioavailability and Food Effect Study of CVN424 | A Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension &Tablet Formulations Including an Assessment of the Effect of Food on the Tablet Formulation in Healthy Adult Volunteers | Parkinson Disease | Drug: CVN424 | Cerevance Beta, Inc. | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 10 | NCT05603312 (ClinicalTrials.gov) | October 5, 2022 | 12/10/2022 | A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants | A Randomized, Double-Blind, Sham-Controlled Study to Evaluate the Safety and Tolerability of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease | Parkinson Disease | Genetic: AAV-GAD Dose 1;Genetic: AAV-GAD Dose 2;Procedure: Sham Surgery | MeiraGTx, LLC | NULL | Recruiting | 25 Years | 85 Years | All | 14 | Phase 1/Phase 2 | United States |
| 11 | NCT05543252 (ClinicalTrials.gov) | August 29, 2022 | 13/9/2022 | An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of UCB0599 in Study Participants With Parkinson's Disease | A Dose-Blinded Extension Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson's Disease | Parkinson's Disease | Drug: UCB0599 | UCB Biopharma SRL | NULL | Enrolling by invitation | 40 Years | 78 Years | All | 270 | Phase 2 | United States;France;Germany;Netherlands;Poland |
| 12 | NCT05418673 (ClinicalTrials.gov) | August 26, 2022 | 10/6/2022 | A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants With Parkinson's Disease and Pathogenic LRRK2 Variants | Parkinson Disease | Drug: BIIB122;Drug: BIIB122-Matching Placebo | Biogen | Denali Therapeutics Inc. | Recruiting | 30 Years | 80 Years | All | 400 | Phase 3 | United States;France;Spain |
| 13 | NCT05523570 (ClinicalTrials.gov) | August 22, 2022 | 24/8/2022 | A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension | Phase 1, Non-randomized, Single Ascending Doses (SAD) Study Following Single Injection in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HNC364 Injectable Suspension | Parkinson's Disease | Drug: HNC364 | Guangzhou Henovcom Bioscience Co. Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 18 | Phase 1 | United States |
| 14 | NCT05357989 (ClinicalTrials.gov) | August 3, 2022 | 19/4/2022 | A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD | A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease | Parkinson's Disease, Idiopathic | Drug: Buntanetap;Drug: Placebo | Annovis Bio Inc. | TFS Trial Form Support | Recruiting | 40 Years | 85 Years | All | 450 | Phase 3 | United States;Germany;Hungary;Italy;Poland;Spain |
| 15 | NCT04147949 (ClinicalTrials.gov) | August 2022 | 27/10/2019 | AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia | Randomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia | Parkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic Use | Drug: AV-101;Drug: Placebo | VistaGen Therapeutics, Inc. | NULL | Not yet recruiting | 30 Years | 80 Years | All | 20 | Phase 2 | NULL |
| 16 | NCT05670782 (ClinicalTrials.gov) | July 19, 2022 | 21/12/2022 | A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease | A Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KM-819 in Healthy Older Adults and Participants With Parkinson's Disease | Parkinson Disease | Drug: KM-819;Drug: Placebo | FAScinate Therapeutics Inc. | Parexel | Recruiting | 40 Years | N/A | All | 330 | Phase 2 | United States |
| 17 | NCT03903549 (ClinicalTrials.gov) | July 15, 2022 | 3/4/2019 | Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy Volunteers | A Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2) | Parkinson Disease | Drug: [18F]P17-059 | Five Eleven Pharma, Inc. | NULL | Completed | 45 Years | 90 Years | All | 4 | Phase 1 | United States |
| 18 | NCT05318937 (ClinicalTrials.gov) | July 6, 2022 | 1/4/2022 | A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Parkinson's Disease Cognitive Impairment | Parkinson Disease;Cognitive Dysfunction | Drug: SAGE-718;Drug: SAGE-718-matching placebo | Sage Therapeutics | NULL | Recruiting | 50 Years | 75 Years | All | 76 | Phase 2 | United States |
| 19 | JPRN-UMIN000047341 | 2022/07/01 | 31/03/2022 | Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. | Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. - Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. | Parkinson's disease | The dance exercise group will have one online lesson per week with a coach, 60 minutes (see Appendix for details) and 30 minutes of video dance (movement review and lesson) as a home trainer to perform the exercises. The active control group was instructed to perform stretching, flexibility, and relaxation exercises (excluding strength, balance, aerobic, and functional training) three times a week for 30 minutes per session. These exercises were selected from several physical therapy programs created for persons with Parkinson's disease. | Department of Neurology, Fukuoka university | NULL | Pending | 30years-old | 75years-old | Male and Female | 60 | Not selected | Japan |
| 20 | NCT05344365 (ClinicalTrials.gov) | June 2022 | 18/4/2022 | A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis | An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP) | Parkinson Disease Psychosis | Drug: Iloperidone | Vanda Pharmaceuticals | NULL | Recruiting | 65 Years | N/A | All | 24 | Phase 2 | United States |
| 21 | NCT05348785 (ClinicalTrials.gov) | April 19, 2022 | 4/4/2022 | A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease | Parkinson Disease | Drug: BIIB122;Drug: BIIB122-Matching Placebo | Biogen | Denali Therapeutics Inc. | Recruiting | 30 Years | 80 Years | All | 640 | Phase 2 | United States;France;Germany;Netherlands;Poland;Spain |
| 22 | NCT05312632 (ClinicalTrials.gov) | April 5, 2022 | 28/3/2022 | A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea | A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea | Parkinson Disease | Drug: Safinamide Mesilate | Eisai Korea Inc. | NULL | Recruiting | 19 Years | N/A | All | 199 | Phase 4 | Korea, Republic of |
| 23 | JPRN-jRCTs052220012 | 01/04/2022 | 22/04/2022 | A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients withParkinson's disease. | A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in patients with Parkinson's disease. a randomized controlled trial | Parkinson's disease Parkinson's disease | The normal rehabilitation group and the HAL grou p are assigned 1: 1 and the normal rehabilitation g roup is subjected to normal walking training, and t he HAL group is subjected to walking training by H AL. | Kohara Nobuo | NULL | Recruiting | >= 20age old | Not applicable | Both | 30 | N/A | Japan |
| 24 | EUCTR2021-000041-40-NL (EUCTR) | 22/02/2022 | 10/11/2021 | A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson’s disease and to understand its mechanism of action | A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson’s disease and to understand its mechanism of action - Microdosing and Parkinson’s disease | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Psilocybin INN or Proposed INN: Psilocybine Product Name: Ketamine INN or Proposed INN: KETAMINE | Maastricht University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Phase 2 | Netherlands | ||
| 25 | NCT05287503 (ClinicalTrials.gov) | February 15, 2022 | 28/1/2022 | Ambroxol as a Disease-modifying Treatment in GBA-PD | Ambroxol as a Disease-modifying Treatment to Reduce the Risk of Cognitive Impairment in GBA-associated Parkinson's Disease. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial | Parkinson Disease;GBA Gene Mutation | Drug: Ambroxol Hydrochloride;Drug: Placebo | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | University of Campania Luigi Vanvitelli;IRCCS National Neurological Institute C. Mondino Foundation | Recruiting | 21 Years | 80 Years | All | 60 | Phase 2 | Italy |
| 26 | NCT05266417 (ClinicalTrials.gov) | February 7, 2022 | 23/2/2022 | Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD) | Parkinson Disease | Drug: INS-GSH;Drug: Matched Placebos | Gateway Institute for Brain Research | NULL | Recruiting | 30 Years | 85 Years | All | 56 | Phase 2 | United States |
| 27 | NCT05274568 (ClinicalTrials.gov) | January 31, 2022 | 1/2/2022 | Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein | Proof of Mechanism Study to Evaluate Binding of Alfa-synuclein by [18F]UCB-2897 in Participants With Parkinson's Disease or Multi-system Atrophy | Parkinson Disease;Multisystem Atrophy;Healthy Volunteer | Drug: [18F]UCB-2897 | Invicro | NULL | Recruiting | 18 Years | N/A | All | 14 | Phase 1 | United States |
| 28 | EUCTR2021-005024-37-NL (EUCTR) | 24/01/2022 | 19/01/2022 | Evaluation of a novel PET tracer [18F]MC225 to measure the function of P-glycoprotein, a transporter at the blood brain barrier, in neurodegenerative disease | Evaluation of [18F]MC225 to measure P-glycoprotein function in neurodegenerative disease | - Alzheimer's disease - Mild Cognitive Impairment - Parkinson's disease;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: [18F]MC225 INN or Proposed INN: [18F]MC225 Other descriptive name: [18F]MC225 | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Netherlands | ||
| 29 | EUCTR2020-002754-24-DE (EUCTR) | 19/01/2022 | 14/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 30 | NCT05094050 (ClinicalTrials.gov) | January 18, 2022 | 20/10/2021 | Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease | Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients | Parkinson's Disease | Drug: ABBV-951 | AbbVie | NULL | Active, not recruiting | 30 Years | N/A | All | 16 | Phase 1 | United States |
| 31 | NCT05083260 (ClinicalTrials.gov) | January 4, 2022 | 23/9/2021 | NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa | A Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107 | Parkinson Disease | Drug: NE3107;Drug: placebo | BioVie Inc. | NULL | Completed | 30 Years | 80 Years | All | 46 | Phase 1/Phase 2 | United States |
| 32 | NCT04858074 (ClinicalTrials.gov) | January 3, 2022 | 7/4/2021 | Study to Investigate the Effect of Hypoestes Rosea Powder in Parkinson's Disease | A Proof of Concept (POC) Study to Investigate the Effect of 100% Hypoestes Rosea Powder in Parkinson's Disease Using ActiGraph Wearable as a Quantitative Assessment Tool. | Parkinson Disease | Drug: Hypoestoxide | University of Ibadan | NULL | Enrolling by invitation | 30 Years | 85 Years | All | 30 | Phase 1/Phase 2 | Nigeria |
| 33 | NCT04265209 (ClinicalTrials.gov) | December 1, 2021 | 6/2/2020 | [18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential Tremor | Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor. | Parkinson Disease;Essential Tremor | Drug: SPECT;Drug: PET | Zionexa | NULL | Recruiting | 35 Years | 80 Years | All | 112 | Phase 3 | France |
| 34 | NCT04990284 (ClinicalTrials.gov) | November 29, 2021 | 27/7/2021 | eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. | A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Opicapone;Drug: L-DOPA/DDCI | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 100 | Phase 4 | Germany;Italy;Portugal;Spain;United Kingdom |
| 35 | EUCTR2019-004235-23-SE (EUCTR) | 13/11/2021 | 24/08/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 36 | NCT04871464 (ClinicalTrials.gov) | November 11, 2021 | 29/4/2021 | Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease | Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study | Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Movement Disorders;Neurodegenerative Diseases;Central Nervous System Diseases;Nervous System Diseases | Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules;Other: Placebo | Beijing Friendship Hospital | NULL | Recruiting | 40 Years | 85 Years | All | 240 | Phase 4 | China |
| 37 | NCT05297201 (ClinicalTrials.gov) | November 2, 2021 | 17/2/2022 | Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients With Levodopa Induced Dyskinesia | Phase II, Double Blind, Randomized, Placebo Controlled, Parallel Group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A Inhibitor) in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesia | Parkinson Disease;Dyskinesia, Medication-Induced | Drug: CPL500036 - low dose;Drug: CPL500036 - high dose;Drug: Placebo | Celon Pharma SA | National Center for Research and Development, Poland | Recruiting | 50 Years | 80 Years | All | 108 | Phase 2 | Poland |
| 38 | NCT04983290 (ClinicalTrials.gov) | November 1, 2021 | 9/6/2021 | Outcomes to the Nutritional Need of Patients With Parkinson's Disease | Clinical Trial to Assess the Effectiveness of the Food Plan Consisting of Products With Modified Consistency Called (Weancare-Domus) in Changing the Quality of Life in Patients With Parkinson's Disease | Deglutition Disorders;Parkinson Disease;Nursing;Quality of Life | Dietary Supplement: weancare-domus | Milko Zanini | Azienda Sanitaria Locale 3 Genovese | Not yet recruiting | 18 Years | N/A | All | 140 | N/A | Italy |
| 39 | NCT05056194 (ClinicalTrials.gov) | November 1, 2021 | 17/9/2021 | Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study | A Double-blind, Randomized, Placebo-controlled, Parallel, Study to Assess the Efficacy and Safety of XW10172 MR for the Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease | Parkinson Disease;Excessive Daytime Somnolence | Drug: Valiloxybate;Other: Placebo | XWPharma | NULL | Not yet recruiting | 40 Years | 75 Years | All | 70 | Phase 2 | NULL |
| 40 | NCT05699161 (ClinicalTrials.gov) | October 14, 2021 | 7/12/2022 | Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson | Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study | Idiopathic Parkinson Disease;Parkinson's Disease and Parkinsonism | Genetic: Adipose-derived stromal vascular fraction cells | Samuel Vilchez, PhD | Wake Forest University;Ministerio de Salud, Nicaragua;GID BIO, Inc.;National Autonomous University of Nicaragua | Completed | 18 Years | 80 Years | All | 10 | Phase 1/Phase 2 | Nicaragua |
| 41 | NCT05084365 (ClinicalTrials.gov) | October 10, 2021 | 7/10/2021 | A 6-month Study to Evaluate Sulforaphane Effects in PD Patients | A 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD Patients | Parkinson Disease | Drug: Sulforaphane;Drug: Placebo | Central South University | NULL | Not yet recruiting | 40 Years | 75 Years | All | 100 | Phase 2 | NULL |
| 42 | NCT04912115 (ClinicalTrials.gov) | October 5, 2021 | 25/5/2021 | Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia | A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's Disease | Dyskinesias;Movement Disorders;Central Nervous System Diseases;Nervous System Diseases;Neurologic Manifestations | Drug: Ketamine;Drug: Midazolam | PharmaTher Inc. | NULL | Suspended | 30 Years | 85 Years | All | 30 | Phase 2 | United States |
| 43 | EUCTR2020-006053-22-SE (EUCTR) | 22/09/2021 | 26/07/2021 | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 versus Placebo in Levodopa-induced Dyskinesia in Parkinson’s Disease | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Preliminary Efficacy of NLX-112 versus Placebo in Levodopa-induced Dyskinesia in Parkinson’s Disease | Parkinson´s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: NLX-112 INN or Proposed INN: BEFIRADOL | Neurolixis SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Sweden | ||
| 44 | NCT04887467 (ClinicalTrials.gov) | September 16, 2021 | 26/4/2021 | Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease | Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment. | Parkinson Disease | Drug: Apomorphine | Rennes University Hospital | NULL | Recruiting | 50 Years | 70 Years | Male | 20 | Phase 4 | France |
| 45 | NCT04691661 (ClinicalTrials.gov) | September 9, 2021 | 16/12/2020 | Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Radotinib in Parkinson's Disease | Parkinson Disease | Drug: Radotinib HCl 50 mg;Drug: Placebo | Il-Yang Pharm. Co., Ltd. | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 46 | EUCTR2020-002754-24-IT (EUCTR) | 09/09/2021 | 30/08/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg tablets Product Name: SINEMET 100 mg + 25 mg compresse Product Code: [023145028] INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: Carbidopa Trade Name: Madopar 125 mg T, tablets Product Name: Madopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride) Product Code: [6036937.00.01] INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: Levodopa Other descriptive name: Levodopa Trade Name: Ongentys 50 mg hard capsules Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone Other descriptive name: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 47 | EUCTR2020-005011-52-PT (EUCTR) | 03/09/2021 | 29/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Portugal;Serbia;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 48 | NCT05220072 (ClinicalTrials.gov) | August 28, 2021 | 18/11/2021 | Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156 | An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects | Parkinson Disease | Drug: Carbon-14 BIA 28-6156 | Bial R&D Investments, S.A. | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 49 | NCT04857359 (ClinicalTrials.gov) | August 6, 2021 | 21/4/2021 | Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy | Parkinson Disease;Dyskinesia, Drug-Induced;Dyskinesias | Drug: Dipraglurant;Drug: Placebo | Addex Pharma S.A. | NULL | Recruiting | 30 Years | 85 Years | All | 140 | Phase 2/Phase 3 | United States |
| 50 | EUCTR2020-003372-41-ES (EUCTR) | 27/07/2021 | 09/06/2021 | Investigating the DopaFuse® Delivery System in Parkinson’s Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body. | Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL | Motor symptoms in Parkinson’s Disease. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DopaFuse Delivery System INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | SynAgile Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1;Phase 2 | Spain;Luxembourg;Italy | ||
| 51 | EUCTR2020-005011-52-BE (EUCTR) | 19/07/2021 | 07/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 52 | EUCTR2020-006004-16-PL (EUCTR) | 16/07/2021 | 23/04/2021 | Phase II clinical trial to assess anti-dyskinetic efficacy of CPL500036, in patients with levodopa-induced dyskinesia in Parkinson's disease | Phase II, Double blind, Randomized, Placebo controlled, Parallel group, Trial to Explore the Potential Anti-dyskinetic Properties of CPL500036 (PDE10A inhibitor) in Patients with Parkinson's Disease Suffering from Levodopa Induced Dyskinesia | Levodopa-induced dyskinesia in Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PG203 INN or Proposed INN: CPL500036 Other descriptive name: CPL500036 | Celon Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 2 | Poland | ||
| 53 | EUCTR2020-003265-19-IT (EUCTR) | 15/07/2021 | 07/06/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson's Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease - - | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: [UCB0599] Trade Name: DaTSCAN Product Name: DaTSCAN Product Code: [DaTSCAN] INN or Proposed INN: IODIO IOFLUPANO-123I | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;Italy | ||
| 54 | EUCTR2020-002754-24-ES (EUCTR) | 06/07/2021 | 09/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 55 | EUCTR2020-005011-52-FR (EUCTR) | 23/06/2021 | 01/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 56 | NCT04821687 (ClinicalTrials.gov) | June 17, 2021 | 25/3/2021 | A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD | A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 Study to Evaluate the Add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease | Parkinson Disease | Drug: Ongentys 50mg;Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg | SK Chemicals Co., Ltd. | NULL | Recruiting | 30 Years | N/A | All | 200 | Phase 4 | Korea, Republic of |
| 57 | EUCTR2020-004997-23-PL (EUCTR) | 09/06/2021 | 03/09/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 58 | NCT04986995 (ClinicalTrials.gov) | June 9, 2021 | 27/7/2021 | OpicApone Sleep dISorder | Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders | Parkinson Disease | Drug: Opicapone | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 30 | Phase 4 | Portugal |
| 59 | EUCTR2020-003265-19-DE (EUCTR) | 07/06/2021 | 01/12/2020 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | France;United States;Canada;Spain;Poland;Netherlands;Germany;Italy;United Kingdom | ||
| 60 | NCT04978597 (ClinicalTrials.gov) | May 31, 2021 | 5/7/2021 | Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension | Parkinson | Drug: Opicapone 50 mg;Drug: Placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | 80 Years | All | 324 | Phase 3 | Bulgaria |
| 61 | EUCTR2019-002952-17-BG (EUCTR) | 31/05/2021 | 21/05/2021 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 62 | EUCTR2020-005011-52-IT (EUCTR) | 28/05/2021 | 04/06/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson's Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, with an Open- Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone Product Code: [BIA 9-1067] INN or Proposed INN: OPICAPONE | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 63 | EUCTR2020-004997-23-AT (EUCTR) | 27/05/2021 | 16/03/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | Austria;United Kingdom;Italy;France;United States;Canada;Spain;Poland | ||
| 64 | EUCTR2020-003265-19-ES (EUCTR) | 26/05/2021 | 09/02/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 INN or Proposed INN: - | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Canada;Poland;Spain;Netherlands;Germany;United Kingdom;Italy | ||
| 65 | EUCTR2020-004997-23-ES (EUCTR) | 25/05/2021 | 01/09/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Poland;Spain;Austria;United Kingdom;Italy | ||
| 66 | EUCTR2019-004235-23-DE (EUCTR) | 19/05/2021 | 25/02/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan;Sweden | ||
| 67 | EUCTR2020-005011-52-BG (EUCTR) | 17/05/2021 | 22/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 68 | EUCTR2020-005011-52-CZ (EUCTR) | 12/05/2021 | 04/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 69 | EUCTR2020-004997-23-FR (EUCTR) | 11/05/2021 | 02/03/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | United States;France;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 70 | EUCTR2020-001176-15-DE (EUCTR) | 07/05/2021 | 17/12/2020 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 71 | NCT04777331 (ClinicalTrials.gov) | May 5, 2021 | 26/2/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease | A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease | Parkinsons Disease | Drug: Prasinezumab;Drug: Placebo | Hoffmann-La Roche | Prothena Biosciences Limited | Recruiting | 50 Years | 85 Years | All | 575 | Phase 2 | United States;Austria;Canada;France;Italy;Luxembourg;Poland;Spain;United Kingdom;Germany |
| 72 | EUCTR2020-003265-19-NL (EUCTR) | 04/05/2021 | 24/02/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 INN or Proposed INN: - Other descriptive name: - | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | United States;France;Canada;Spain;Poland;Germany;Netherlands;United Kingdom;Italy | ||
| 73 | NCT04802733 (ClinicalTrials.gov) | May 3, 2021 | 12/3/2021 | Phase 1 Safety and Tolerability Study of MSK-DA01 Cell Therapy for Advanced Parkinson's Disease | Phase 1 Study To Assess the Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy (MSK-DA01) For Advanced Parkinson's Disease | Advanced Parkinson's Disease | Biological: MSK-DA01;Device: MSK-DA01 Cell Delivery Device | BlueRock Therapeutics | Memorial Sloan Kettering Cancer Center | Active, not recruiting | 50 Years | 78 Years | All | 12 | Phase 1 | United States;Canada |
| 74 | EUCTR2020-003265-19-PL (EUCTR) | 30/04/2021 | 18/01/2021 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 2 | France;United States;Canada;Spain;Poland;Germany;Netherlands;United Kingdom;Italy | ||
| 75 | NCT04867642 (ClinicalTrials.gov) | April 29, 2021 | 27/4/2021 | A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | Healthy Study Participants;Parkinson's Disease | Drug: UCB0022;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | Phase 1 | United Kingdom |
| 76 | NCT04377945 (ClinicalTrials.gov) | April 28, 2021 | 4/5/2020 | Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components | A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components | Dyskinesias;Parkinson Disease | Drug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, JM-010 component Group C;Drug: Part 2, Placebo Group | Bukwang Pharmaceutical | NULL | Recruiting | 18 Years | 85 Years | All | 188 | Phase 2 | United States |
| 77 | EUCTR2020-003265-19-FR (EUCTR) | 28/04/2021 | 04/12/2020 | A 18-month study to evaluate the efficacy, safety, tolerability and pharmacokinetics of oral UCB0599 in study participants with early-stage Parkinson’s Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson’s Disease | Early-stage Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: UCB0599 Product Code: UCB0599 | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Canada;Spain;Poland;Netherlands;Germany;United Kingdom;Italy | ||
| 78 | EUCTR2018-004892-11-IT (EUCTR) | 22/04/2021 | 07/10/2020 | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients | A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients - SteP-on | •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD•A Modified Hoehn and Yahr stage of = 4 in the off” state;•A stable (4 weeks since last modification) anti-parkinsonian therapy; •The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs frozen” or glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Trade Name: XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE Product Name: Xadago Product Code: [043906039] INN or Proposed INN: SAFINAMIDE METANSOLFONATO | OSPEDALE SANTA MARIA DELLA MISERICORDIA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 128 | Phase 3 | Italy | ||
| 79 | EUCTR2021-000867-65-DE (EUCTR) | 19/04/2021 | 16/03/2021 | Investigation of the adhesion properties of a newly developed rotigotine-containing patch in patients with Parkinson's disease | Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed rotigotine-containing transdermal patch in patients with Parkinson's disease | Idiopathic Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Product Name: ROT-TDS 8 mg/24 h INN or Proposed INN: ROTIGOTINE Trade Name: Neupro® 8 mg/24 h Product Name: Neupro® 8 mg/24 h INN or Proposed INN: ROTIGOTINE | Luye Pharma Switzerland AG | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 80 | EUCTR2020-004997-23-IT (EUCTR) | 19/04/2021 | 08/06/2021 | A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease | A PHASE IIB, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE - NA | Early Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: [RO7046015] INN or Proposed INN: Prasinezumab Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 575 | Phase 2 | France;United States;Canada;Spain;Poland;Austria;United Kingdom;Italy | ||
| 81 | ChiCTR2100045506 | 2021-04-19 | 2021-04-18 | The immediate effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson’s disease | The immediate effects of rhythmic auditory stimulation on upper-limb movements in patients with Parkinson’s disease | Parkinson Disease | Healthy people group:Different frequency of RAS;Parkinson's disease group:Different frequency of RAS; | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | NULL | Recruiting | Male | Healthy people group:36;Parkinson's disease group:36; | China | |||
| 82 | ChiCTR2100044662 | 2021-04-01 | 2021-03-25 | Study on exosome biomarkers in Parkinson's disease | Study on exosome biomarkers in Parkinson's disease | Parkinson’s disease | Gold Standard:Clinically established Parkinson's disease conforming to China Diagnostic Criteria for Parkinson's Disease (2016);Index test:Exosome biomarkers (miRNA and a-synuclein); | The First Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 21 | 100 | Both | Target condition:1200;Difficult condition:0 | China | |
| 83 | NCT04491383 (ClinicalTrials.gov) | April 1, 2021 | 22/7/2020 | Tocotrienols in Parkinson's Disease (PD) | Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial | Neuro-Degenerative Disease;Parkinson Disease | Drug: Tocovid Suprabio (HOV-12020);Other: Placebo | National Neuroscience Institute | Hovid Berhad | Recruiting | 40 Years | 90 Years | All | 100 | Phase 2 | Singapore |
| 84 | EUCTR2019-000247-27-FR (EUCTR) | 31/03/2021 | 05/03/2019 | Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor. | Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP | Patients suffering from an essential tremor or with Parkinson's disease. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10015496;Term: Essential tremor;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: DaTSCAN 74 MBq/ml solution for injection Product Code: [18F] LBT-999 | ZIONEXA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 3 | France | ||
| 85 | EUCTR2019-002952-17-DE (EUCTR) | 30/03/2021 | 18/09/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Czech Republic | ||
| 86 | JPRN-jRCTs051200160 | 24/03/2021 | 24/03/2021 | ZEAL study | Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease: A Randomized Single-Blind Placebo-Controlled Trial - ZEAL | Parkinson's disease Parkinson's disease,Somnipathy;D010300 | 70 patients with Parkinson's disease were allocated to Zonisamide tablets (Trelief OD tablets) 1T (25mg) or placebo 1T at a time before going to bed by randomizing soft, and the efficacy of zonisamide tablet (Trelief OD tablets) for sleep is investigated comparing the parallel-group before and after administration | Hiroshi Kataoka | NULL | Recruiting | >= 41age old | Not applicable | Both | 70 | Phase 2-3 | Japan |
| 87 | EUCTR2020-001176-15-PT (EUCTR) | 19/03/2021 | 04/01/2021 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg hard capsules INN or Proposed INN: OPICAPONE Other descriptive name: OPICAPONE | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Portugal;Germany | ||
| 88 | NCT04764669 (ClinicalTrials.gov) | February 25, 2021 | 19/2/2021 | A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology | An Open-Label Study To Evaluate the Pharmacodynamic Effects, Efficacy, Safety, and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies or Parkinson's Disease Dementia With or Without Amyloid Copathology | Lewy Body Disease;Parkinson Disease | Drug: E2027 | Eisai Inc. | NULL | Completed | 50 Years | 85 Years | All | 34 | Phase 2 | United States;Canada |
| 89 | NCT04986982 (ClinicalTrials.gov) | February 25, 2021 | 27/7/2021 | OpiCapone Effect on Motor Fluctuations and pAiN | Randomised, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Pain. | Parkinson Disease | Drug: Opicapone 50 mg;Other: Matching placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 140 | Phase 4 | United Kingdom |
| 90 | EUCTR2019-002952-17-IT (EUCTR) | 19/02/2021 | 25/01/2021 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5 mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON Product Name: Tavapadon 0.25 mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Other descriptive name: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 91 | NCT04750226 (ClinicalTrials.gov) | February 18, 2021 | 10/2/2021 | Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease | An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Enrolling by invitation | 30 Years | N/A | All | 130 | Phase 3 | United States;Australia |
| 92 | NCT04350177 (ClinicalTrials.gov) | February 16, 2021 | 26/12/2019 | A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants and Parkinson's Patients | A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers With Extension Into Parkinson's Patients | Healthy Elderly;Parkinson Disease | Drug: IkT-148009;Drug: Placebo | Inhibikase Therapeutics, Inc. | NULL | Completed | 55 Years | 70 Years | All | 101 | Phase 1 | United States |
| 93 | NCT04643327 (ClinicalTrials.gov) | February 9, 2021 | 18/11/2020 | Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease | Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study | Parkinson Disease;Mild Cognitive Impairment;Memory Impairment | Drug: Levetiracetam;Drug: Placebo | The University of Queensland | Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's Hospital;Queensland University of Technology | Recruiting | N/A | N/A | All | 28 | Phase 2 | Australia |
| 94 | NCT04593511 (ClinicalTrials.gov) | February 2, 2021 | 21/9/2020 | to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers | An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection | Parkinson's Disease | Drug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4 | Luye Pharma Group Ltd. | NULL | Enrolling by invitation | 18 Years | 65 Years | All | 40 | Phase 1 | Australia |
| 95 | EUCTR2020-003372-41-IT (EUCTR) | 27/01/2021 | 15/06/2021 | Investigating the DopaFuse® Delivery System in Parkinson's Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body. | Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse® Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL | Motor symptoms in Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DopaFuse Delivery System Product Code: [N04BA] INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa | SynAgile Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain;Luxembourg;Italy | ||
| 96 | NCT04625361 (ClinicalTrials.gov) | January 20, 2021 | 9/11/2020 | Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects | A Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese Subjects | Parkinson Disease | Drug: HEC122505MsOH | Sunshine Lake Pharma Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 102 | Phase 1 | China |
| 97 | EUCTR2020-001175-32-PT (EUCTR) | 15/01/2021 | 30/09/2020 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson’s disease | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Opicapone 50 mg hard capsules INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 98 | EUCTR2019-002949-38-BG (EUCTR) | 13/01/2021 | 21/12/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 99 | NCT04277247 (ClinicalTrials.gov) | January 12, 2021 | 10/2/2020 | Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's Disease | Botulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control Study | Dystonia Disorder;Parkinson Disease | Drug: Botulinum toxin type A;Drug: Placebo | University of Calgary | Allergan | Recruiting | 30 Years | 100 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 100 | EUCTR2019-002951-40-BG (EUCTR) | 11/01/2021 | 05/01/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 101 | EUCTR2019-002952-17-HU (EUCTR) | 30/12/2020 | 19/10/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| 102 | NCT04658186 (ClinicalTrials.gov) | December 30, 2020 | 1/12/2020 | A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease | Early-stage Parkinson's Disease | Drug: UCB0599;Drug: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 40 Years | 75 Years | All | 490 | Phase 2 | United States;Canada;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 103 | NCT04685265 (ClinicalTrials.gov) | December 22, 2020 | 17/12/2020 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food of anle138b in Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: anle138b;Drug: Placebo | MODAG GmbH | Aptuit (Verona) Srl, an Evotec Company;Quotient Sciences;Nottingham University Hospitals NHS Trust | Active, not recruiting | 40 Years | 80 Years | All | 72 | Phase 1 | United Kingdom |
| 104 | EUCTR2020-001175-32-IT (EUCTR) | 17/12/2020 | 15/06/2021 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's disease | Randomized, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson's disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations and associated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 105 | NCT04651153 (ClinicalTrials.gov) | December 14, 2020 | 25/11/2020 | A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD) | A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's Disease | Parkinson's Disease | Drug: UCB7853;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | 80 Years | All | 57 | Phase 1 | Netherlands;United Kingdom |
| 106 | EUCTR2019-004235-23-DK (EUCTR) | 18/11/2020 | 22/06/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Denmark;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 107 | EUCTR2019-004235-23-NL (EUCTR) | 09/11/2020 | 26/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 108 | EUCTR2019-002952-17-CZ (EUCTR) | 04/11/2020 | 12/10/2020 | A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease | 58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 854 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 109 | EUCTR2019-002951-40-IT (EUCTR) | 30/10/2020 | 21/01/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 110 | NCT04542499 (ClinicalTrials.gov) | October 27, 2020 | 2/9/2020 | Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 368 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Poland;Serbia;Spain;Ukraine |
| 111 | NCT03947216 (ClinicalTrials.gov) | October 23, 2020 | 7/5/2019 | Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease. | Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease | Parkinson Disease | Drug: Active drug: pimavanserin 17mg (2 strength tablets);Drug: Placebo: 2 tablets containing same excipients except active compound;Behavioral: Assessment of severity of ICD (impulse control disorders);Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors;Behavioral: Assessment of quality of life;Behavioral: Assessment of depression;Behavioral: Assessment of cognition;Behavioral: Assessment of severity of Parkinson Disease;Procedure: Blood analysis;Procedure: Cardiac monitoring | University Hospital, Strasbourg, France | NS-PARK;EUCLID Clinical Trial Platform;F-CRIN | Recruiting | 35 Years | 75 Years | All | 130 | Phase 2 | France |
| 112 | EUCTR2020-003796-17-GB (EUCTR) | 22/10/2020 | 01/09/2020 | A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory. | An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139 | Patients with Mild Cognitive Impairment or Parkinson’s Disease MedDRA version: 21.1;Level: LLT;Classification code 10009846;Term: Cognitive impairment;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Spiropent Product Name: Clenbuterol HCl Product Code: CST-103 INN or Proposed INN: CLENBUTEROL HYDROCHLORIDE Trade Name: Berachin Product Name: Tulobuterol Product Code: CST-139 INN or Proposed INN: Tolubuterol Hydrochloride Other descriptive name: TULOBUTEROL HYDROCHLORIDE | CuraSen Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | United Kingdom | ||
| 113 | NCT04334317 (ClinicalTrials.gov) | October 21, 2020 | 30/3/2020 | A Study of TAK-071 in People With Parkinson Disease | A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls | Parkinson Disease;Healthy Participants | Drug: TAK-071;Drug: Placebo | Takeda | Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 85 Years | All | 64 | Phase 2 | United States |
| 114 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 174 | Phase 3 | United States;Australia |
| 115 | ChiCTR2000036137 | 2020-10-01 | 2020-08-21 | Clinical study of 18F-FDG combined with 18F-AV-133 PET/CT imaging in the diagnosis and differentiation of primary Parkinson's disease | Clinical study of 18F-FDG combined with 18F-AV-133 PET/CT imaging in the diagnosis and differentiation of primary Parkinson's disease | Parkinson’s disease | Gold Standard:UK Parkinson's disease Society Brain Bank Clinical Diagnosis Criteria;Index test:18F-FDG combined with 18F-AV-133 PET/CT imaging; | Renji Hospital (South Court), School of Medicine, Shanghai Jiao Tong University | NULL | Pending | Both | Target condition:50;Difficult condition:0 | China | |||
| 116 | ChiCTR2000037239 | 2020-10-01 | 2020-08-27 | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Parkinson's disease | Gold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip; | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 55 | 80 | Both | Target condition:500;Difficult condition:600 | China | |
| 117 | ChiCTR2000037856 | 2020-10-01 | 2020-09-02 | Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA) | Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA) | Parkinson's Disease | Gold Standard:DAT-PET and 18F-FDG PET ;Index test:a-synuclein protein misfolding cyclic amplification; | Huashan Hospital Affiliated to Fudan University | NULL | Recruiting | 50 | 75 | Both | Target condition:150;Difficult condition:76 | China | |
| 118 | NCT04338997 (ClinicalTrials.gov) | October 2020 | 3/4/2020 | PK Study in Patients With Parkinson's Disease With IZD174 | An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease | Parkinson Disease | Drug: IZD174 | Inflazome UK Ltd | NULL | Withdrawn | 45 Years | 75 Years | All | 0 | Phase 1 | NULL |
| 119 | EUCTR2020-001175-32-GB (EUCTR) | 29/09/2020 | 07/08/2020 | Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease. | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;Italy;United Kingdom | ||
| 120 | EUCTR2019-004235-23-GB (EUCTR) | 15/09/2020 | 28/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Japan;United Kingdom | ||
| 121 | NCT04476017 (ClinicalTrials.gov) | September 11, 2020 | 15/7/2020 | A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI) | An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment | Parkinson Disease;Cognitive Dysfunction | Drug: SAGE-718 | Sage Therapeutics | NULL | Completed | 50 Years | 75 Years | All | 18 | Phase 2 | United States |
| 122 | EUCTR2019-002949-38-DE (EUCTR) | 07/09/2020 | 21/01/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 552 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 123 | ChiCTR2000037828 | 2020-09-01 | 2020-09-02 | Clinical study of Wuqinxi combined with selegilan in improving frozen gait of Parkinson's disease | Clinical study of Wuqinxi combined with selegilan in improving frozen gait of Parkinson's disease | Parkinson's disease | Group 1:Routine anti PD treatment + stretching training;Group 2:Routine anti PD treatment + stretching training + selegiline;Group 3:Routine anti PD treatment + Wuqinxi training;Group 4:Routine anti PD treatment + Wuqinxi training + selegiline; | Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of science and technology | NULL | Recruiting | 40 | 80 | Male | Group 1:30;Group 2:30;Group 3:30;Group 4:30; | China | |
| 124 | EUCTR2019-004235-23-IT (EUCTR) | 26/08/2020 | 22/10/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. - na | Parkinson's Disease MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Foscarbidopa and Foslevodopa Product Code: [ABBV-951] INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Netherlands;United Kingdom;Japan;Italy | ||
| 125 | NCT04524351 (ClinicalTrials.gov) | August 14, 2020 | 11/8/2020 | Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD) | Alzheimer Disease;Parkinson Disease | Drug: Posiphen | Annovis Bio Inc. | Parexel | Completed | 45 Years | N/A | All | 75 | Phase 1/Phase 2 | United States |
| 126 | NCT04449484 (ClinicalTrials.gov) | August 4, 2020 | 23/4/2019 | Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: MEDI1341;Other: Placebo | AstraZeneca | Takeda | Completed | 40 Years | 85 Years | All | 25 | Phase 1 | United States |
| 127 | NCT04483479 (ClinicalTrials.gov) | July 30, 2020 | 20/7/2020 | Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover) | A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period | Parkinson Disease;Constipation | Drug: Active Investigational Treatment ENT-01 | Enterin Inc. | NULL | Completed | 30 Years | 90 Years | All | 28 | Phase 2 | United States |
| 128 | EUCTR2019-002951-40-DE (EUCTR) | 29/07/2020 | 12/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 129 | NCT04630860 (ClinicalTrials.gov) | July 7, 2020 | 5/11/2020 | A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD | A Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1 | China |
| 130 | EUCTR2019-002951-40-HU (EUCTR) | 02/07/2020 | 29/04/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 131 | EUCTR2018-004156-37-PT (EUCTR) | 16/06/2020 | 09/12/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD/CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of | ||
| 132 | EUCTR2018-004156-37-NL (EUCTR) | 14/06/2020 | 13/01/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 133 | NCT04379050 (ClinicalTrials.gov) | June 8, 2020 | 1/5/2020 | Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease | An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Active, not recruiting | 30 Years | N/A | All | 130 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom |
| 134 | EUCTR2019-002951-40-CZ (EUCTR) | 03/06/2020 | 25/02/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 135 | NCT04384666 (ClinicalTrials.gov) | June 2, 2020 | 8/5/2020 | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 56 | Phase 1 | United States |
| 136 | ChiCTR2000032616 | 2020-05-30 | 2020-05-04 | Assistant diagnosis machinery system development based on speech and movement sensitive device for Parkinson's disease | Parkinson's disease, Assistant diagnosis machinery system, speech, movement sensitive device | Parkinson's disease | Gold Standard:clinical outcome meet 2015 MDS-probable PD criteria;Index test:Acoustic receptive and analysis device,Wearable movement sensor; | Shanghai Jiao Tong University School of Medicine affiliated Shanghai General Hospital | NULL | Pending | Both | Target condition:20;Difficult condition:80 | China | |||
| 137 | EUCTR2019-002949-38-IT (EUCTR) | 21/05/2020 | 21/01/2021 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY,AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON'S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 TRIAL | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 138 | EUCTR2019-002950-22-IT (EUCTR) | 21/05/2020 | 15/06/2021 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease | A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO 2 Trial) - TEMPO-2 Trial | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON Product Name: Tavapadon 1mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON Product Name: Tavapadon 0.25mg Product Code: [CVL-751] INN or Proposed INN: Tavapadon Other descriptive name: TAVAPADON | Cerevel Therapeutics LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 3 | Serbia;United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Canada;Poland;Australia;Bulgaria;Germany | ||
| 139 | EUCTR2018-004156-37-SE (EUCTR) | 18/05/2020 | 10/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 140 | EUCTR2019-002949-38-PL (EUCTR) | 13/05/2020 | 20/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 141 | NCT04571164 (ClinicalTrials.gov) | May 11, 2020 | 21/9/2020 | A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | Parkinson Disease | Drug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheres | Luye Pharma Group Ltd. | Parexel | Recruiting | 30 Years | N/A | All | 294 | Phase 3 | China |
| 142 | EUCTR2018-002144-85-DE (EUCTR) | 07/05/2020 | 06/06/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Japan | ||
| 143 | EUCTR2019-002950-22-HU (EUCTR) | 06/05/2020 | 12/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease | A Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| 144 | EUCTR2018-004156-37-IT (EUCTR) | 04/05/2020 | 17/06/2021 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP Product Code: [NA] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: [ND0612] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 145 | EUCTR2018-004156-37-SK (EUCTR) | 30/04/2020 | 13/02/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa/Carbidopa Solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 146 | NCT03959540 (ClinicalTrials.gov) | April 28, 2020 | 23/4/2019 | Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Levodopa (L-DOPA) + Standard care | Bial - Portela C S.A. | NULL | Completed | 75 Years | N/A | All | 39 | United Kingdom | |
| 147 | EUCTR2018-004156-37-BE (EUCTR) | 27/04/2020 | 03/03/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 148 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 149 | EUCTR2019-002951-40-ES (EUCTR) | 14/04/2020 | 06/03/2020 | A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor Fluctuations | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 | Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 368 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 150 | EUCTR2019-002949-38-ES (EUCTR) | 07/04/2020 | 28/02/2020 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 151 | NCT02967250 (ClinicalTrials.gov) | April 1, 2020 | 13/9/2016 | Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment | 7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment | Parkinson Disease | Drug: ursodeoxycholic acid | University of Minnesota | NULL | Not yet recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 152 | EUCTR2020-000686-16-NL (EUCTR) | 26/03/2020 | 09/03/2020 | Validation of finger tapping in PD patients | Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 125 Product Name: SINEMET Product Code: RVG 08740 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopamonohydraat Other descriptive name: CARBIDOPA MONOHYDRATE | Centre for Human Drug Research | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 153 | EUCTR2019-003962-41-GB (EUCTR) | 23/03/2020 | 06/02/2020 | Trial of Ondansetron as a Parkinson's HAllucinations Treatment: TOP HAT | Trial of Ondansetron as a Parkinson’s HAllucinations Treatment - TOP HAT | Adults aged over 18 years with Parkinson's disease and visual hallucinations MedDRA version: 21.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | Trade Name: Ondansetron 8 mg film-coated tablets Product Name: Ondansetron 8 mg film-coated tablets INN or Proposed INN: Ondansetron hydrochloride dihydrate | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 2 | United Kingdom | ||
| 154 | NCT04269642 (ClinicalTrials.gov) | March 19, 2020 | 13/1/2020 | SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease | Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease | Early Parkinson's Disease | Drug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mg | Peptron, Inc. | NULL | Active, not recruiting | 40 Years | 75 Years | All | 99 | Phase 2 | Korea, Republic of |
| 155 | EUCTR2017-003415-19-IT (EUCTR) | 10/03/2020 | 19/05/2021 | A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010 | Parkinson’s Disease Patients With Moderate to Severe Dyskinesia MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan | Contera Pharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | France;Spain;Germany;Italy | ||
| 156 | EUCTR2018-003941-41-AT (EUCTR) | 05/03/2020 | 19/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 157 | EUCTR2019-002949-38-CZ (EUCTR) | 04/03/2020 | 19/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) - TEMPO-1 Trial | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | United States;Czechia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany | ||
| 158 | NCT04127695 (ClinicalTrials.gov) | March 3, 2020 | 9/10/2019 | A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ABBV-0805;Drug: Placebo ABBV-0805 | AbbVie | NULL | Withdrawn | N/A | 85 Years | All | 0 | Phase 1 | United States;Puerto Rico |
| 159 | EUCTR2018-004156-37-AT (EUCTR) | 02/03/2020 | 05/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 160 | NCT04870372 (ClinicalTrials.gov) | March 1, 2020 | 15/1/2020 | Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease | A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease | Parkinson Disease | Drug: Selegiline | Second Affiliated Hospital of Soochow University | NULL | Completed | 30 Years | 80 Years | All | 141 | Phase 4 | China |
| 161 | NCT04154072 (ClinicalTrials.gov) | February 27, 2020 | 4/11/2019 | A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease | Parkinson Disease | Drug: NLY01;Drug: Vehicle | Neuraly, Inc. | NULL | Active, not recruiting | 30 Years | 80 Years | All | 255 | Phase 2 | United States;Canada |
| 162 | NCT04291859 (ClinicalTrials.gov) | February 26, 2020 | 28/2/2020 | Lu AF28996 in Participants With Parkinson's Disease (PD) | Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's Disease | Parkinson Disease | Drug: Lu AF28996 | H. Lundbeck A/S | NULL | Recruiting | 45 Years | 75 Years | All | 37 | Phase 1 | United States;Netherlands |
| 163 | EUCTR2018-004156-37-ES (EUCTR) | 11/02/2020 | 06/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Korea, Republic of;Poland;Italy;Israel;Slovakia;France;Serbia | ||
| 164 | EUCTR2019-002949-38-HU (EUCTR) | 06/02/2020 | 17/12/2019 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease | Product Name: Tavapadon 0.25mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 1mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 Product Name: Tavapadon 5mg Product Code: CVL-751 INN or Proposed INN: TAVAPADON Other descriptive name: PF-06649751 | Cerevel Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 522 | Phase 3 | Hungary;United States;Ukraine;Spain;Canada;Czech Republic;Sweden;Poland;Italy;Israel;Australia;Bulgaria;France;Serbia;Germany | ||
| 165 | NCT04251585 (ClinicalTrials.gov) | February 4, 2020 | 28/1/2020 | Intranasal Insulin in Parkinson's Disease | Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease | Parkinson Disease | Drug: Regular Novolin R;Drug: Placebo | HealthPartners Institute | NULL | Recruiting | 41 Years | 89 Years | All | 30 | Phase 2 | United States |
| 166 | EUCTR2018-003941-41-PT (EUCTR) | 03/02/2020 | 21/08/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 167 | NCT04220762 (ClinicalTrials.gov) | January 21, 2020 | 17/12/2019 | A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients | A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study | Parkinson Disease | Drug: WIN-1001X;Drug: Placebo | Medi Help Line | NULL | Recruiting | 30 Years | N/A | All | 188 | Phase 2 | Korea, Republic of |
| 168 | NCT04369430 (ClinicalTrials.gov) | January 16, 2020 | 13/4/2020 | Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment | Parkinson Disease | Drug: AKST4290;Drug: Placebo | Alkahest, Inc. | NULL | Completed | 50 Years | 80 Years | All | 110 | Phase 2 | United States;Estonia;Germany;Poland;Slovakia;Hungary |
| 169 | EUCTR2018-004156-37-GB (EUCTR) | 14/01/2020 | 13/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Korea, Republic of;Poland;Italy;Israel;Slovakia;France;Serbia | ||
| 170 | EUCTR2019-001657-42-SK (EUCTR) | 14/01/2020 | 01/10/2019 | A study to learn how well the drug AKST4290 works and how safeAKST4290 is in people who have Parkinson's disease that are takingdopamine based medication. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of AKST4290 in Subjects with Parkinson's Disease onStable Dopaminergic Treatment. - N/A | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AKST4290 Product Code: AKST4290 INN or Proposed INN: AKST4290 Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE | Alkahest, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Estonia;Slovakia;Poland;Germany | ||
| 171 | NCT04295642 (ClinicalTrials.gov) | January 8, 2020 | 24/1/2020 | A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease | A 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: CVL-751 | Cerevel Therapeutics, LLC | NULL | Completed | 45 Years | 75 Years | All | 24 | Phase 1 | United States |
| 172 | NCT04223193 (ClinicalTrials.gov) | January 6, 2020 | 7/1/2020 | Flexible-Dose Trial in Early Parkinson's Disease (PD) | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 296 | Phase 3 | United States;Australia;France;Germany;Hungary;Italy;Poland;Serbia;Spain;Ukraine |
| 173 | NCT04226248 (ClinicalTrials.gov) | January 2, 2020 | 5/12/2019 | CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) | CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease. | Parkinson Disease | Drug: Rivastigmine Transdermal System;Other: Placebo Transdermal System | University of Bristol | Royal United Hospitals Bath NHS Foundation Trust | Recruiting | 18 Years | N/A | All | 600 | Phase 3 | United Kingdom |
| 174 | NCT04152655 (ClinicalTrials.gov) | January 1, 2020 | 7/10/2019 | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease | A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD) | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Idebenone;Drug: Placebo oral tablet | Second Affiliated Hospital, School of Medicine, Zhejiang University | Peking Union Medical College Hospital;Beijing Hospital;Beijing Tiantan Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Jiangsu Province Nanjing Brain Hospital;The First Affiliated Hospital of Anhui Medical University;Huashan Hospital;Tongji Hospital;Second Affiliated Hospital of Soochow University;Guizhou Medical University;The First Affiliated Hospital of Guangzhou Medical University;Peking University Shenzhen Hospital;West China Hospital;Wuhan Union Hospital, China;Sir Run Run Shaw Hospital;The Affiliated Hospital of Hangzhou Normal University;The First Affiliated Hospital of Dalian Medical University;Qilu Hospital of Shandong University | Recruiting | 18 Years | N/A | All | 180 | Phase 2/Phase 3 | China |
| 175 | NCT03815916 (ClinicalTrials.gov) | December 19, 2019 | 18/1/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease | A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Parkinson's Disease | Parkinson's Disease | Drug: Gold Nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Completed | 30 Years | 80 Years | All | 13 | Phase 2 | United States |
| 176 | EUCTR2018-004156-37-HU (EUCTR) | 19/12/2019 | 18/10/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 177 | NCT04164121 (ClinicalTrials.gov) | December 17, 2019 | 12/11/2019 | A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers | A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers | Parkinson Disease | Drug: Phenlarmide Tablets;Drug: Placebos | Yiling Pharmaceutical Inc. | NULL | Completed | 18 Years | 65 Years | All | 36 | Phase 1 | China |
| 178 | NCT04201093 (ClinicalTrials.gov) | December 13, 2019 | 13/12/2019 | Fixed-Dose Trial in Early Parkinson's Disease (PD) | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL) | Parkinson Disease | Drug: Tavapadon;Drug: Placebo | Cerevel Therapeutics, LLC | NULL | Recruiting | 40 Years | 80 Years | All | 522 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Israel;Italy;Poland;Spain;Ukraine |
| 179 | EUCTR2018-004156-37-CZ (EUCTR) | 26/11/2019 | 26/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 180 | NCT04301492 (ClinicalTrials.gov) | November 20, 2019 | 17/2/2020 | Tolerability, Safety and Efficacy of Vortioxetine | Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study | Depression | Drug: Vortioxetine | IRCCS San Raffaele Roma | NULL | Recruiting | 30 Years | 80 Years | All | 20 | Phase 4 | Italy |
| 181 | NCT03924414 (ClinicalTrials.gov) | November 15, 2019 | 2/4/2019 | Trial of Parkinson's And Zoledronic Acid | TOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's Disease | Parkinson Disease;Osteoporosis;Parkinsonism;Parkinson's Disease and Parkinsonism;Atypical Parkinsonism;Progressive Supranuclear Palsy;Multiple System Atrophy;Vascular Parkinsonism;Dementia With Lewy Bodies | Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: Placebo | California Pacific Medical Center Research Institute | National Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's Foundation | Recruiting | 60 Years | N/A | All | 3500 | Phase 4 | United States |
| 182 | ChiCTR1900027306 | 2019-11-15 | 2019-11-08 | Application of optical coherence tomography and detection of a-synuclein in tears in the diagnosis of Parkinson's disease | Morphological changes of retina in patients with Parkinson's disease and the role of a-synuclein in retinal damage | Parkinson's disease | Gold Standard:British brain bank Parkinson's disease diagnostic criteria;Index test:Application of optical coherence tomography to observe the retinal structure of the macular area, optic disc area and the expression level of a-synuclein in tears in the diagnosis of Parkinson's disease.; | The First Affiliated Hospital of Chengdu Medical College | NULL | Recruiting | Both | Target condition:85;Difficult condition:85 | China | |||
| 183 | NCT04148391 (ClinicalTrials.gov) | November 14, 2019 | 30/10/2019 | NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking) | A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia | Mild Cognitive Impairment;Mild Dementia;Parkinson Disease;Lewy Body Disease | Drug: Placebo Oral Capsule;Drug: NYX-458 | Aptinyx | CogState Ltd.;Worldwide Clinical Trials | Active, not recruiting | 50 Years | 80 Years | All | 99 | Phase 2 | United States |
| 184 | NCT04175132 (ClinicalTrials.gov) | November 12, 2019 | 12/11/2019 | Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD) | Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: foliglurax | H. Lundbeck A/S | NULL | Terminated | 50 Years | 70 Years | All | 6 | Phase 1 | Sweden |
| 185 | NCT04164758 (ClinicalTrials.gov) | October 23, 2019 | 13/11/2019 | Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine | A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine | Parkinson's Disease | Drug: Pimavanserin;Other: Placebo;Drug: Quetiapine | ACADIA Pharmaceuticals Inc. | NULL | Terminated | 50 Years | 85 Years | All | 11 | Phase 2 | United States |
| 186 | EUCTR2019-001657-42-DE (EUCTR) | 22/10/2019 | 11/06/2019 | A study to learn how well the drug AKST4290 works and how safe AKST4290 is in people who have Parkinson's disease that are taking dopamine based medication. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on Stable Dopaminergic Treatment - N/A | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AKST4290 Product Code: AKST4290 INN or Proposed INN: AKST4290 Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE | Alkahest, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Estonia;Slovakia;Poland;Germany | ||
| 187 | EUCTR2018-003337-15-ES (EUCTR) | 17/10/2019 | 30/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India | ||
| 188 | NCT04157933 (ClinicalTrials.gov) | October 16, 2019 | 1/11/2019 | Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease | A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease | Parkinson's Disease | Drug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossover | Alexza Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 35 | Phase 1 | Netherlands |
| 189 | NCT04165837 (ClinicalTrials.gov) | October 14, 2019 | 13/11/2019 | Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects | Parkinson's Disease | Drug: FB-101;Drug: Placebo | 1ST Biotherapeutics, Inc. | NULL | Completed | 19 Years | 55 Years | All | 24 | Phase 1 | United States |
| 190 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 191 | EUCTR2018-003941-41-BG (EUCTR) | 10/10/2019 | 26/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 192 | NCT03987750 (ClinicalTrials.gov) | October 2019 | 12/6/2019 | Safinamide for Levodopa-induced Dyskinesia (PD-LID) | A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor Fluctuations | Dyskinesia, Drug-Induced;Parkinson Disease | Drug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placebo | Zambon SpA | NULL | Withdrawn | 30 Years | N/A | All | 0 | Phase 3 | NULL |
| 193 | EUCTR2018-003941-41-IT (EUCTR) | 17/09/2019 | 18/01/2021 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: [TD-9855] INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand;Estonia;Spain;Ukraine;Portugal;United States | ||
| 194 | EUCTR2018-002144-85-NL (EUCTR) | 11/09/2019 | 27/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 195 | NCT04075318 (ClinicalTrials.gov) | August 29, 2019 | 5/8/2019 | Study of UB-312 in Healthy Participants and Parkinson's Disease Patients | A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease | Parkinson's Disease;Parkinsonism | Biological: UB-312;Biological: Placebo | United Neuroscience Ltd. | Centre for Human Drug Research, Netherlands;Worldwide Clinical Trials;Vaxxinity, Inc. | Active, not recruiting | 40 Years | 85 Years | All | 70 | Phase 1 | Netherlands |
| 196 | NCT04006210 (ClinicalTrials.gov) | August 27, 2019 | 30/6/2019 | Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | Parkinson's Disease | Combination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mg | NeuroDerm Ltd. | NULL | Active, not recruiting | 30 Years | 80 Years | All | 381 | Phase 3 | United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| 197 | EUCTR2018-003941-41-PL (EUCTR) | 23/08/2019 | 03/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand | ||
| 198 | EUCTR2018-002144-85-BE (EUCTR) | 20/08/2019 | 24/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 199 | EUCTR2018-003941-41-ES (EUCTR) | 13/08/2019 | 11/06/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 200 | NCT03976349 (ClinicalTrials.gov) | August 12, 2019 | 4/6/2019 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease | A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's Disease | Parkinson's Disease | Drug: BIIB094;Drug: Placebo | Biogen | Ionis Pharmaceuticals, Inc. | Recruiting | 35 Years | 80 Years | All | 82 | Phase 1 | United States;Canada;Israel;Norway;Spain;United Kingdom |
| 201 | NCT04043338 (ClinicalTrials.gov) | August 11, 2019 | 24/7/2019 | Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects | Parkinson's Disease | Drug: XC130-A10H;Drug: Placebo | Xoc Pharmaceuticals | Celerion | Active, not recruiting | 18 Years | 75 Years | All | 56 | Phase 1 | United States |
| 202 | EUCTR2018-003941-41-GB (EUCTR) | 09/08/2019 | 16/05/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 203 | JPRN-UMIN000037422 | 2019/08/01 | 01/08/2019 | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months. | Ichinomiya Nishi Hospital | NULL | Complete: follow-up continuing | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 204 | JPRN-UMIN000037421 | 2019/08/01 | 01/08/2019 | A study on improvement of cognitive function by istradefylline for parkinson disease | An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease | Parkinson disease | Prescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months. The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26. | Ichinomiya Nishi Hospital | NULL | Complete: follow-up continuing | 40years-old | 85years-old | Male and Female | 25 | Not selected | Japan |
| 205 | NCT03881371 (ClinicalTrials.gov) | August 1, 2019 | 18/3/2019 | A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa | Parkinson Disease | Drug: Safinamide;Other: Placebo | Zambon SpA | NULL | Completed | 18 Years | N/A | All | 307 | Phase 3 | China |
| 206 | EUCTR2018-003941-41-HU (EUCTR) | 30/07/2019 | 01/08/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
| 207 | EUCTR2018-002144-85-GB (EUCTR) | 29/07/2019 | 13/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom | ||
| 208 | NCT04056689 (ClinicalTrials.gov) | July 23, 2019 | 12/8/2019 | Study to Evaluate DNL151 in Subjects With Parkinson's Disease | A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: DNL151;Drug: Placebo | Biogen | NULL | Completed | 30 Years | 75 Years | All | 36 | Phase 1 | United States;Belgium;Netherlands;United Kingdom |
| 209 | NCT03575195 (ClinicalTrials.gov) | July 15, 2019 | 21/6/2018 | Microbiota Intervention to Change the Response of Parkinson's Disease | Microbiota Intervention to Change the Response of Parkinson's Disease | Parkinson Disease | Drug: Rifaximin;Other: Placebo | University of California, San Francisco | Nova Southeastern University;Gateway Institute for Brain Research | Recruiting | 30 Years | N/A | All | 86 | Phase 1/Phase 2 | United States |
| 210 | EUCTR2018-002144-85-ES (EUCTR) | 11/07/2019 | 12/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 211 | EUCTR2018-002144-85-DK (EUCTR) | 08/07/2019 | 14/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 212 | EUCTR2018-003941-41-EE (EUCTR) | 04/07/2019 | 29/05/2019 | This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) | A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Study | Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: TD-9855 INN or Proposed INN: ampreloxetine hydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Denmark;Australia;Peru;Bulgaria;Germany;New Zealand | ||
| 213 | JPRN-UMIN000037390 | 2019/07/01 | 16/07/2019 | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy - Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor | Parkinson's disease | Entacapone 100mg | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | Saiseikai Matsuyama Hospital | Pending | 20years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 214 | ChiCTR1900021708 | 2019-07-01 | 2019-03-05 | Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphi | Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphism | Parkinson's Disease | Healthy control group:No;tremor-dominant phenotype PD patients group:pramipexole; | Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University | NULL | Pending | 50 | 70 | Both | Healthy control group:80;tremor-dominant phenotype PD patients group:80; | China | |
| 215 | EUCTR2018-003219-23-GB (EUCTR) | 28/06/2019 | 04/06/2019 | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease) | CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD | This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h Product Code: N/A INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Trade Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h Product Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) Product Name: Rivastigmine transdermal system 13.3 mg/24 h Product Code: RIV-TDS 13.3 mg/24 h INN or Proposed INN: Rivastigmine Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below) | University of Bristol | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United Kingdom | ||
| 216 | EUCTR2018-002144-85-IT (EUCTR) | 21/06/2019 | 15/06/2021 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde | Parkinson's Disease MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ABBV-951 Product Code: [ABBV-951] INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan;Italy | ||
| 217 | EUCTR2018-003337-15-HU (EUCTR) | 18/06/2019 | 12/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Spain;Poland;India | ||
| 218 | NCT03938922 (ClinicalTrials.gov) | June 13, 2019 | 18/4/2019 | A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease Dementia | A Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia. | Parkinson Disease;Dementia | Drug: Active Investigational Treatment ENT-01 | Enterin Inc. | NULL | Active, not recruiting | 30 Years | 90 Years | All | 40 | Phase 1 | United States |
| 219 | EUCTR2018-003337-15-SK (EUCTR) | 05/06/2019 | 26/04/2019 | A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease | Early Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 Product Code: K0706 INN or Proposed INN: K0706 Other descriptive name: K0706 | Sun Pharma Advanced Research Company (SPARC) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 504 | Phase 2 | United States;Hungary;Slovakia;Spain;Poland;India | ||
| 220 | NCT03971617 (ClinicalTrials.gov) | May 29, 2019 | 30/5/2019 | Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease | Parkinson Disease | Drug: Hydrogen;Drug: Placebo oral tablet | Stony Brook University | NULL | Terminated | 40 Years | 80 Years | All | 2 | Phase 2/Phase 3 | United States |
| 221 | JPRN-jRCTs031180248 | 29/05/2019 | 12/03/2019 | N/A | Intervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease - Istra adjust PD | Parkinson's disease | Arm with treatment of Istradefylline and levodopa Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 1. Dose reduction is possible if the patient has tolerability issues. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. Arm without treatment of Istradefylline 50mg levodopa will be added at Week 0. Patients will visit every 4 weeks from the following day of Week0, and 50mg levodopa will be added of if CGI-S score >=4 every time. Dose reduction is possible if the patient has tolerability issues. | Hatano Taku | Kyowa Kirin Co., Ltd | Complete | >= 30age old | <= 84age old | Both | 111 | N/A | Japan |
| 222 | NCT03693872 (ClinicalTrials.gov) | May 15, 2019 | 1/10/2018 | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Parkinson Disease | Drug: Apomorphine;Drug: Dopaminergic Agonist + Apomorphine | Rennes University Hospital | NULL | Recruiting | 18 Years | N/A | All | 42 | N/A | France |
| 223 | NCT03671785 (ClinicalTrials.gov) | May 15, 2019 | 12/9/2018 | Study of the Fecal Microbiome in Patients With Parkinson's Disease | A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's Disease | Parkinson Disease | Drug: PRIM-DJ2727;Drug: Placebo oral capsule | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Active, not recruiting | 55 Years | 75 Years | All | 12 | Phase 1 | United States |
| 224 | NCT03970239 (ClinicalTrials.gov) | May 13, 2019 | 6/5/2019 | Serotonin in Impulse Control Disorders in Parkinson's Disease | Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease | Parkinson Disease;Impulse Control Disorders | Drug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin);Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin) | Hospices Civils de Lyon | NULL | Recruiting | 30 Years | 80 Years | All | 45 | N/A | France |
| 225 | NCT04875962 (ClinicalTrials.gov) | May 6, 2019 | 3/5/2021 | A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD) | A Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: UCB0599;Drug: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 40 Years | 80 Years | All | 31 | Phase 1 | United States |
| 226 | EUCTR2018-002233-37-IT (EUCTR) | 03/05/2019 | 07/01/2021 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. - NA | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: [IPX203] INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: [IR CD-LD] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 227 | NCT03781167 (ClinicalTrials.gov) | April 29, 2019 | 18/12/2018 | A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD) | A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 244 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France |
| 228 | NCT03899324 (ClinicalTrials.gov) | April 26, 2019 | 29/3/2019 | Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease | Parkinson Disease | Drug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tablet | B&A Therapeutics | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 229 | JPRN-JapicCTI-194763 | 22/4/2019 | 20/05/2019 | Safety and PK study of LY03003 | An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. | Parkinson's Disease | Intervention name : Rotigotine INN of the intervention : Rotigotine Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week. Control intervention name : Rotigotine INN of the control intervention : Rotigotine Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day. | Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd. | NULL | complete | 20 | BOTH | 32 | Phase 1 | Japan | |
| 230 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 231 | NCT03661125 (ClinicalTrials.gov) | April 11, 2019 | 4/9/2018 | SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis | A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis. | Parkinson Disease Psychosis | Drug: Saracatinib;Drug: Placebo Oral Tablet | King's College London | AstraZeneca;King's College Hospital NHS Trust | Recruiting | 40 Years | N/A | All | 30 | Early Phase 1 | United Kingdom |
| 232 | NCT03841604 (ClinicalTrials.gov) | April 9, 2019 | 30/1/2019 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain | Idiopathic Parkinson Disease | Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo | Zambon SpA | NULL | Completed | 30 Years | N/A | All | 71 | Phase 4 | Austria;France;Germany;Italy;Spain |
| 233 | EUCTR2017-002426-20-FR (EUCTR) | 05/04/2019 | 26/11/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria | ||
| 234 | EUCTR2016-000657-12-GR (EUCTR) | 04/04/2019 | 11/01/2019 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: - Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Taiwan;United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 235 | ChiCTR1800015757 | 2019-04-01 | 2018-04-18 | Value of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's disease | Value of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's disease | Parkinson's Disease | Gold Standard:PD diagnostic criteria made by MDS in 2016;Index test:reduced uptake in salivery gland and myocardium in I-131-MIBG scintigraphic imaging; | Tongji hospital, Tongji University | NULL | Pending | Both | Target condition:30;Difficult condition:30 | China | |||
| 236 | NCT03922711 (ClinicalTrials.gov) | March 26, 2019 | 17/4/2019 | A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease | A Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe) | Parkinson Disease | Drug: Pridopidine;Drug: Placebo | Prilenia | NULL | Terminated | 30 Years | 85 Years | All | 23 | Phase 2 | United States |
| 237 | EUCTR2018-002233-37-CZ (EUCTR) | 18/03/2019 | 11/12/2018 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy | ||
| 238 | NCT03716570 (ClinicalTrials.gov) | March 12, 2019 | 22/10/2018 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease | A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease | Parkinson's Disease | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 24 | Phase 1 | Japan |
| 239 | NCT03820037 (ClinicalTrials.gov) | March 2019 | 25/1/2019 | Relative Bioavailability and Bioequivalence of Opicapone | A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects | Parkinson Disease | Drug: Ongentys;Drug: BIA 9-1067 (test) | Bial - Portela C S.A. | NULL | Not yet recruiting | 18 Years | 55 Years | All | 45 | Phase 1 | United Kingdom |
| 240 | EUCTR2017-002426-20-IT (EUCTR) | 21/02/2019 | 07/10/2020 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson's Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago Product Code: [-] INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METHANESULFONATE | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | Germany;Italy;France;Spain;Austria | ||
| 241 | NCT03968744 (ClinicalTrials.gov) | February 18, 2019 | 19/4/2019 | Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease | A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study | Idiopathic Parkinson's Disease (at Later Stage) | Drug: Safinamide | Alain Kaelin | Clinical Trial Unit Ente Ospedaliero Cantonale | Recruiting | 18 Years | N/A | All | 23 | Phase 4 | Switzerland |
| 242 | NCT03413384 (ClinicalTrials.gov) | February 15, 2019 | 8/1/2018 | To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | A Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ceftriaxone;Other: Placebo | BrainX Corporation | Virginia Contract Research Organization Co., Ltd. | Recruiting | 50 Years | 80 Years | All | 106 | Phase 2 | Taiwan |
| 243 | NCT04510922 (ClinicalTrials.gov) | February 11, 2019 | 9/7/2020 | Lundbeck TOMs Orthostatic Hypotension | Technology-Based Objective Measures for Gait and Postural Assessment in Parkinson Disease Patients With Orthostatic Hypotension: Feasibility and Effect-Size Finding Study | Orthostatic Hypotension;Idiopathic Parkinson Disease | Drug: Droxidopa 100 MG [Northera] | Alberto Espay, MD, MSc | Lundbeck LLC | Completed | 30 Years | 80 Years | All | 10 | Phase 4 | United States |
| 244 | NCT03790670 (ClinicalTrials.gov) | January 30, 2019 | 18/12/2018 | Biomarker Assessments of Leukine During Treatment of Parkinson's Disease | Safety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot Study | Parkinson Disease | Drug: sargramostim | University of Nebraska | NULL | Active, not recruiting | 35 Years | 85 Years | All | 7 | Phase 1 | United States |
| 245 | EUCTR2017-003458-18-SE (EUCTR) | 23/01/2019 | 10/12/2018 | A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia | A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790 | Integrative Research Laboratories AB (IRLAB) | NULL | Not Recruiting | Female: yes Male: yes | 74 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
| 246 | EUCTR2017-002426-20-AT (EUCTR) | 22/01/2019 | 03/12/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 4 | Spain;Austria | ||
| 247 | NCT03826134 (ClinicalTrials.gov) | January 17, 2019 | 30/1/2019 | A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects | Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy Subjects | Parkinson Disease | Drug: [11C]PXT012253 | H. Lundbeck A/S | NULL | Completed | 20 Years | 50 Years | All | 7 | Early Phase 1 | Sweden |
| 248 | NCT03391882 (ClinicalTrials.gov) | December 19, 2018 | 2/1/2018 | A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations | Motor OFF Episodes Associated With Parkinson's Disease | Drug: APL-130277;Drug: subcutaneous apomorphine | Sunovion | NULL | Completed | 18 Years | N/A | All | 113 | Phase 3 | Austria;France;Germany;Italy;Spain;United Kingdom |
| 249 | NCT03840005 (ClinicalTrials.gov) | December 18, 2018 | 11/2/2019 | Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP Study | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Ursonorm | Sheffield Teaching Hospitals NHS Foundation Trust | JP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of Sheffield | Completed | 18 Years | 75 Years | All | 31 | Phase 2 | United Kingdom |
| 250 | NCT03781791 (ClinicalTrials.gov) | December 10, 2018 | 27/11/2018 | Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET) | Constipation;Parkinson Disease | Drug: Active Investigational Treatment ENT-01;Drug: Placebo Treatment | Enterin Inc. | NULL | Completed | 30 Years | 90 Years | All | 144 | Phase 2 | United States |
| 251 | NCT03710707 (ClinicalTrials.gov) | December 4, 2018 | 15/10/2018 | Study to Evaluate DNL201 in Subjects With Parkinson's Disease | A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: DNL201;Drug: Placebo | Denali Therapeutics Inc. | NULL | Completed | 30 Years | 80 Years | All | 29 | Phase 1 | United States |
| 252 | NCT03944447 (ClinicalTrials.gov) | December 1, 2018 | 3/5/2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;Coronavirus | Drug: Cannabis, Medical;Device: RYAH-Medtech Inhaler | OMNI Medical Services, LLC | OMNI Medical Services Inc | Recruiting | 7 Years | N/A | All | 200000 | Phase 2 | United States |
| 253 | NCT03639064 (ClinicalTrials.gov) | December 2018 | 4/7/2018 | Cannabis Oil for Pain in Parkinson's Disease | A Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's Disease | Parkinson Disease | Drug: Cannabis Oil | University Health Network, Toronto | Parkinson Society Canada | Unknown status | 18 Years | N/A | All | 15 | Phase 2 | NULL |
| 254 | NCT03822364 (ClinicalTrials.gov) | November 26, 2018 | 18/12/2018 | Staccato Apomorphine Single and Multi Dose PK | A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5 | Alexza Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 60 Years | All | 56 | Phase 1 | Netherlands |
| 255 | NCT03823638 (ClinicalTrials.gov) | November 20, 2018 | 20/11/2018 | Safety, Tolerability and Effects of Mannitol in Parkinson's Disease | A Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's Disease | Parkinson Disease | Dietary Supplement: Oral D-Mannitol of Placebo | Hadassah Medical Organization | NULL | Recruiting | 40 Years | 75 Years | All | 60 | Phase 2 | Israel |
| 256 | NCT03713957 (ClinicalTrials.gov) | November 12, 2018 | 18/10/2018 | A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment | Parkinson Disease | Drug: GRF6021;Other: Placebo | Alkahest, Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 85 Years | All | 79 | Phase 2 | United States;Australia;France |
| 257 | NCT03733561 (ClinicalTrials.gov) | November 9, 2018 | 6/11/2018 | A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro | A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers | Parkinson Disease | Drug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 40 | Phase 1 | United States |
| 258 | EUCTR2018-001887-46-GB (EUCTR) | 08/11/2018 | 19/06/2019 | Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | Parkinson’s disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ursonorm Product Name: Ursonorm INN or Proposed INN: Ursodeoxycholic acid | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 259 | NCT03667404 (ClinicalTrials.gov) | November 6, 2018 | 10/9/2018 | Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study | Gut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability Study | Parkinson Disease;Intestinal Bacteria Flora Disturbance;Dietary Modification | Dietary Supplement: maltodextrin;Dietary Supplement: Resistant maltodextrin | Northwestern University | University of Illinois at Chicago | Active, not recruiting | 60 Years | N/A | All | 30 | Phase 2 | United States |
| 260 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 631 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 261 | NCT04629404 (ClinicalTrials.gov) | November 5, 2018 | 5/11/2020 | A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: LY03003;Drug: Placebo | Luye Pharma Group Ltd. | NULL | Completed | 30 Years | N/A | All | 32 | Phase 1 | China |
| 262 | JPRN-JapicCTI-184181 | 01/11/2018 | 30/10/2018 | Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term Safety | AZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety | Parkinson's disease | Intervention name : Rasagiline INN of the intervention : rasagiline Dosage And administration of the intervention : Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | complete | BOTH | 1021 | NA | Japan | ||
| 263 | EUCTR2017-003415-19-ES (EUCTR) | 31/10/2018 | 20/08/2018 | A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable. | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations Of JM-010 | Parkinson’s Disease Patients With Moderate to Severe Dyskinesia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan Product Name: JM-010 Product Code: JM-010 INN or Proposed INN: Buspirone hydrochloride INN or Proposed INN: Zolmitriptan | Contera Pharma | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Spain;Germany | ||
| 264 | EUCTR2016-002033-30-NL (EUCTR) | 31/10/2018 | 15/11/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 265 | EUCTR2017-002426-20-ES (EUCTR) | 19/10/2018 | 20/08/2018 | Effect of Safinamide on Parkinson’s Disease Related Chronic Pain | A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study | Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE Trade Name: Xadago Product Name: Xadago INN or Proposed INN: Safinamide methansulfonate Other descriptive name: SAFINAMIDE METHANESULFONATE | Zambon SpA | NULL | Not Recruiting | Female: yes Male: yes | 177 | Phase 4 | France;Spain;Austria;Italy | ||
| 266 | EUCTR2018-000346-19-FI (EUCTR) | 03/10/2018 | 09/07/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 267 | EUCTR2016-004610-95-DE (EUCTR) | 01/10/2018 | 27/02/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | France;United States;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 268 | NCT03665454 (ClinicalTrials.gov) | September 24, 2018 | 1/8/2018 | PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | A Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's Disease | Parkinson Disease | Drug: PF-06412562;Drug: Standard of Care Placebo | Milton S. Hershey Medical Center | Pfizer | Completed | N/A | N/A | All | 8 | Phase 1 | United States |
| 269 | NCT03582137 (ClinicalTrials.gov) | September 17, 2018 | 17/4/2018 | A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease | Parkinson Disease | Drug: Cannabidiol;Other: Placebo | University of Colorado, Denver | Colorado Department of Public Health and Environment | Completed | 40 Years | 85 Years | All | 74 | Phase 2 | United States |
| 270 | NCT03608371 (ClinicalTrials.gov) | August 31, 2018 | 9/5/2018 | BTRX-246040 Study in Subjects With Parkinson's Disease With Motor Fluctuations | Phase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson Disease;Motor Disorder | Drug: BTRX-246040;Drug: Placebo | BlackThorn Therapeutics, Inc. | NULL | Completed | 30 Years | 76 Years | All | 24 | Phase 2 | United States |
| 271 | EUCTR2016-004610-95-FR (EUCTR) | 08/08/2018 | 01/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 272 | NCT03773796 (ClinicalTrials.gov) | August 6, 2018 | 19/7/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and Efficacy | Parkinson Disease | Drug: Nabilone 0.25 mg | Medical University Innsbruck | NULL | Recruiting | 30 Years | 100 Years | All | 48 | Phase 3 | Austria |
| 273 | JPRN-JMA-IIA00385 | 01/08/2018 | 12/09/2018 | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Parkinson's disease | Intervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value.. | Kyoto University Hospital | NULL | Completed | >=50 YEARS | <70 YEARS | BOTH | 7 | Phase 3 | Japan |
| 274 | ChiCTR1800017084 | 2018-08-01 | 2018-07-11 | Investigation of new approaches and technologies in the management of Parkinson's disease | The efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial | Parkinson's disease | Butylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks; | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 80 | Both | Butylphthalide group:140;Control group:140; | Phase 4 | China |
| 275 | JPRN-UMIN000033409 | 2018/07/30 | 17/07/2018 | Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. | Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. - SkinHeRo | Parkinson's disease | Pretreatment by heparinoid In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks. Non-pretreatment by heparinoid. The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks. | Wakayama Medical University | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 20 | Phase 1 | Japan |
| 276 | NCT03611569 (ClinicalTrials.gov) | July 25, 2018 | 26/7/2018 | Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease | Healthy;Parkinson Disease | Drug: Lu AF82422;Drug: Placebo | H. Lundbeck A/S | NULL | Completed | 18 Years | 80 Years | All | 74 | Phase 1 | United States |
| 277 | NCT03774459 (ClinicalTrials.gov) | July 9, 2018 | 8/12/2018 | ANAVEX2-73 Study in Parkinson's Disease Dementia | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With Dementia | Parkinsons Disease With Dementia | Drug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsule | Anavex Life Sciences Corp. | Anavex Germany GmbH | Completed | 50 Years | 85 Years | All | 132 | Phase 2 | Australia;Spain |
| 278 | NCT03775538 (ClinicalTrials.gov) | July 5, 2018 | 11/10/2018 | Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002 | Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 15 | Phase 1/Phase 2 | Finland;Sweden |
| 279 | EUCTR2018-001209-95-IT (EUCTR) | 05/07/2018 | 03/08/2021 | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001 | Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill¿ Carbidopa/levodopa Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI Product Name: Sinemet Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Spain;Italy | ||
| 280 | EUCTR2017-004335-36-ES (EUCTR) | 04/07/2018 | 11/04/2018 | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. | A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. - A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 | Cognition in Parkinson’s Disease with dementia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 Product Name: ANAVEX2-73 INN or Proposed INN: ANAVEX2-73 | Anavex Life Sciences Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | Spain | ||
| 281 | JPRN-UMIN000033454 | 2018/07/01 | 20/07/2018 | A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. | A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. - A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. | Parkinson's Disease | robot assisted balance training (RABT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16. traditional balance training (TBT) The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16. | Hyogo College of Medicine | NULL | Complete: follow-up complete | 40years-old | 80years-old | Male and Female | 50 | Not selected | Japan |
| 282 | NCT03576638 (ClinicalTrials.gov) | July 2018 | 25/6/2018 | Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients | An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease | Parkinson Disease | Drug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 12 | Phase 2 | NULL |
| 283 | NCT03562494 (ClinicalTrials.gov) | June 28, 2018 | 16/5/2018 | VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1) | A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Biological: VY-AADC02;Other: Sham (Placebo) Surgery | Neurocrine Biosciences | Voyager Therapeutics | Active, not recruiting | 40 Years | 75 Years | All | 85 | Phase 2 | United States |
| 284 | NCT03407378 (ClinicalTrials.gov) | June 26, 2018 | 15/1/2018 | A Study to Investigate a New Treatment in Patients With Parkinson's Disease | A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease | Parkinson Disease | Drug: IPT803;Genetic: Optional pharmacogenetic assessment;Other: Questionnaires;Other: Optional Blood-Oxygen-level Dependent functionalMRI;Other: Motor Assessments before taking regular PD treatment;Other: Motor Assessments on regular PD treatment | Tools4Patient | NULL | Completed | 35 Years | N/A | All | 110 | Phase 1/Phase 2 | United States;Belgium;France |
| 285 | EUCTR2017-001420-21-DE (EUCTR) | 18/06/2018 | 16/02/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. | Early Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: P2B001 INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Product Name: Pramipexole dihydrochloride INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Product Name: Rasagiline INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Pramipexole dihydrochloride extended-release tablets Product Name: Pramipexole dihydrochloride extended-release tablets INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE | Pharma Two B Ltd | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 286 | EUCTR2017-001420-21-ES (EUCTR) | 13/06/2018 | 15/03/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. | Early Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: P2B001 INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Product Name: Pramipexole dihydrochloride INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Product Name: Rasagiline INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Pramipexole dihydrochloride extended-release tablets Product Name: Pramipexole dihydrochloride extended-release tablets INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE | Pharma Two B Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | United States;France;Canada;Spain;Germany | ||
| 287 | NCT03439943 (ClinicalTrials.gov) | June 13, 2018 | 13/2/2018 | Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease | Multicenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's Disease | Parkinson Disease | Drug: Lixisenatide;Drug: placebo | University Hospital, Toulouse | Cure Parkinson;Réseau NS-Park;EUCLID;Sanofi | Active, not recruiting | 40 Years | 75 Years | All | 156 | Phase 2 | France |
| 288 | EUCTR2017-004006-18-NL (EUCTR) | 07/06/2018 | 15/11/2017 | The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease | Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease | Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: Madopar 125 mg, orodispersible tablet | Pharmaceutical Technology and Biopharmacy, University of Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Phase 2 | Netherlands | ||
| 289 | EUCTR2018-000346-19-SE (EUCTR) | 04/06/2018 | 09/04/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 290 | NCT03510572 (ClinicalTrials.gov) | June 4, 2018 | 17/4/2018 | Evaluation of [18F]PI-2620 as a Potential Positron Emission Computed Tomography Radioligand for Imaging Tau Protein in the Brain | Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study | Healthy Volunteer;Alzheimer Disease;Frontotemporal Dementia;Parkinson Disease | Drug: [18F]PI-2620 | Asan Medical Center | Korea Health Industry Development Institute | Completed | 40 Years | 80 Years | All | 20 | Early Phase 1 | Korea, Republic of |
| 291 | NCT04730245 (ClinicalTrials.gov) | June 1, 2018 | 25/1/2021 | Microbiota Modification for the Treatment of Motor Complication of Parkinson´s Disease | Targeting Gut Microbiota for Motor Complications in Parkinson´s Disease | Parkinson's Disease Aggravated | Drug: sodium phosphate enema, oral rifaximin and polyethylene glycol | Torre Médica Santé | NULL | Completed | 18 Years | N/A | All | 14 | Phase 1 | Mexico |
| 292 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 293 | EUCTR2016-004610-95-ES (EUCTR) | 18/05/2018 | 07/03/2018 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 311 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 294 | NCT03589066 (ClinicalTrials.gov) | May 15, 2018 | 8/6/2018 | Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease | An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 295 | EUCTR2017-004475-31-CZ (EUCTR) | 09/05/2018 | 09/05/2018 | Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. | Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease | Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL | Theranexus S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Germany | ||
| 296 | NCT03541356 (ClinicalTrials.gov) | May 8, 2018 | 5/4/2018 | Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal | A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients | Parkinson's Disease | Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg | Impel NeuroPharma Inc. | NULL | Completed | 40 Years | 80 Years | All | 32 | Phase 2 | Australia |
| 297 | NCT03587649 (ClinicalTrials.gov) | May 7, 2018 | 3/7/2018 | Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss | Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV). | Alzheimer Disease;Parkinson Disease;Healthy Volunteers | Drug: [18F]MNI-1126 | Invicro | NULL | Completed | 18 Years | 55 Years | All | 12 | Phase 1 | United States |
| 298 | EUCTR2016-003456-70-IT (EUCTR) | 04/05/2018 | 02/02/2021 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Disease patients | An Open-Label Randomized Crossover Trial, utilizing a Single-Blinded Rater to evaluate APL- 130277 compared to S.C. Apomorphine in Levodopa Responsive Subjects with Parkinson¿s Disease Complicated by Motor Fluctuations - A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Di | Levodopa Responsive Patients with Parkinson¿s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine Product Code: n/a INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 299 | NCT03843944 (ClinicalTrials.gov) | May 1, 2018 | 12/2/2019 | Overnight Switch From Rasagiline To Safinamide | Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study | Parkinson Disease | Drug: Safinamide | IRCCS San Raffaele Roma | NULL | Completed | 30 Years | 80 Years | All | 20 | Phase 4 | Italy |
| 300 | EUCTR2016-004610-95-GB (EUCTR) | 01/05/2018 | 27/12/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom | ||
| 301 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 302 | NCT03374917 (ClinicalTrials.gov) | April 18, 2018 | 8/12/2017 | A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment | An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 30 Years | 85 Years | All | 20 | Phase 1 | United States |
| 303 | EUCTR2017-004475-31-HU (EUCTR) | 17/04/2018 | 09/02/2018 | Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. | Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease | Excessive daytime sleepiness associated with Parkinson’s disease MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Product Name: Flecainide acetate Product Code: THN02 INN or Proposed INN: Flecainidum Other descriptive name: FLECAINIDE ACETATE Trade Name: Modiodal Product Name: over-encapsulated Modafinil INN or Proposed INN: MODAFINIL | Theranexus S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Hungary;United States;France;Germany | ||
| 304 | EUCTR2017-004253-16-AT (EUCTR) | 13/04/2018 | 27/02/2018 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...) | Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy | Subject with non-Motor symptoms of Parkinson´s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Nabilone INN or Proposed INN: NABILONE | Medizinische Universität Innsbruck, Universitätsklinik für Neurologie | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Austria | ||
| 305 | NCT03368170 (ClinicalTrials.gov) | April 12, 2018 | 5/12/2017 | Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | Parkinson Disease | Drug: Mesdopetam (IRL790) | Integrative Research Laboratories AB | The Clinical Trial Company | Completed | 18 Years | 79 Years | All | 75 | Phase 2 | Sweden;United Kingdom |
| 306 | EUCTR2017-002707-10-DK (EUCTR) | 10/04/2018 | 03/11/2017 | Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effects | Serum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance | Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10075174;Term: Mixed dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Memantin Orion INN or Proposed INN: MEMANTINE Product Name: Donepezil Sandoz Product Code: 25330 INN or Proposed INN: DONEPEZIL | Regional Dementia Research Centre, Dept of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 4 | Denmark | ||
| 307 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 308 | EUCTR2016-002033-30-IT (EUCTR) | 10/04/2018 | 20/01/2021 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 309 | EUCTR2016-003456-70-DE (EUCTR) | 04/04/2018 | 03/04/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 310 | ChiCTR2200057135 | 2018-04-04 | 2022-03-01 | Use of Wii Sports based training to reduce the falls and improve quality of life in people diagnosed as Parkinson's disease | Effectiveness of Wii Sports Training on Postural Stability, Fall and Quality of Life in Idiopathic Parkinson’s Disease. | Parkinson's Disease | Experimental:Wii Sports based training;Control:Traditional Balance training; | Alagumoorthi Gandhisubramanian | NULL | Completed | 40 | 90 | Both | Experimental:96;Control:96; | N/A | India |
| 311 | EUCTR2016-000657-12-AT (EUCTR) | 03/04/2018 | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 312 | EUCTR2018-000405-23-FI (EUCTR) | 27/03/2018 | 21/02/2018 | Postitron emission tomography imaging of neuroinflammation in Parkinson´s disease | In vivo PET imaging of neuroinflammation in Parkinson’s disease using the purinergic P2X7 receptor ligand [11C]SMW139 (PRI-PD) - PRI-PD | Parkinson´s disease MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: (2-chloro-5-[11C]methoxy-N-(((3s,5s,7s)-3,5,7-trifluoroadamantan-1-yl)methyl) benzamide) Product Code: [11C]SMW139 | Juha Rinne / PET Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 14 | Phase 2 | Finland | ||
| 313 | EUCTR2016-004610-95-AT (EUCTR) | 23/03/2018 | 04/01/2018 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB054 INN or Proposed INN: n/a Other descriptive name: BIIB054 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 357 | Phase 2 | United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy | ||
| 314 | NCT03457493 (ClinicalTrials.gov) | March 22, 2018 | 23/2/2018 | The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy | UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy | Parkinson Disease | Drug: DPA-714-PET/MRI | University of Alabama at Birmingham | NULL | Recruiting | 30 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 315 | EUCTR2016-004610-95-IT (EUCTR) | 22/03/2018 | 14/01/2021 | Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson¿s Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson¿s Disease - SPARK | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB054] INN or Proposed INN: HA 1A ANTICORPO MONOCLONALE UMANO CLASSE IGM | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 311 | Phase 2 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy;Sweden | ||
| 316 | EUCTR2016-000637-43-IT (EUCTR) | 05/03/2018 | 21/01/2021 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patientswith Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes). - Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | Levodopa Responsive Patients with Parkinson's Disease complicated by Motor Fluctuations (OFF Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 317 | NCT04265027 (ClinicalTrials.gov) | February 20, 2018 | 7/2/2020 | Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) | An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers. | Parkinson Disease | Drug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg Ongentys | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United Kingdom |
| 318 | NCT03496870 (ClinicalTrials.gov) | February 8, 2018 | 1/3/2018 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. | A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Carbidopa Levodopa | Neurocrine Biosciences | NULL | Completed | 18 Years | 85 Years | All | 16 | Phase 1 | United States |
| 319 | EUCTR2016-000637-43-ES (EUCTR) | 06/02/2018 | 07/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 320 | EUCTR2016-003456-70-ES (EUCTR) | 06/02/2018 | 07/12/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 85 | Phase 3 | Spain;Austria;United Kingdom | ||
| 321 | NCT03189563 (ClinicalTrials.gov) | February 6, 2018 | 12/6/2017 | Safety and Efficacy of DA-9805 for Parkinson's Disease | A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: DA-9805 45mg;Drug: DA-9805 90mg;Other: Placebo | Dong-A ST Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 60 | Phase 2 | United States |
| 322 | EUCTR2016-000637-43-AT (EUCTR) | 01/02/2018 | 15/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 323 | NCT02940912 (ClinicalTrials.gov) | January 31, 2018 | 14/10/2016 | Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Parkinson Disease | Drug: Apomorphine;Drug: Placebo | Clinique Beau Soleil | NULL | Active, not recruiting | 35 Years | 90 Years | All | 45 | Phase 4 | France |
| 324 | NCT03329508 (ClinicalTrials.gov) | January 29, 2018 | 30/10/2017 | A Phase 3 Study With P2B001 in Subjects With Early Parkinson's | A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER. | Parkinson Disease;Early Parkinson's Disease | Drug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ER | Pharma Two B Ltd. | NULL | Active, not recruiting | 35 Years | 80 Years | All | 525 | Phase 3 | United States;Canada;Germany;Spain |
| 325 | EUCTR2016-001403-23-HU (EUCTR) | 23/01/2018 | 22/01/2018 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 326 | NCT03531086 (ClinicalTrials.gov) | January 19, 2018 | 8/5/2018 | Idiopathic Parkinson's Progression and Dopamine Transporter SPECT | Exploring Dopamine Transporter Single-photon Emission Computer Tomography Quantification as a Measure of Disease Progression in Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Ioflupane I 123 | Julie Gurwell | NULL | Completed | 40 Years | 75 Years | All | 12 | United States | |
| 327 | NCT03331848 (ClinicalTrials.gov) | January 15, 2018 | 1/11/2017 | Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED) | Parkinson Disease | Drug: Placebo oral capsule;Drug: PXT002331 - 20mg | Prexton Therapeutics | NULL | Withdrawn | 35 Years | 85 Years | All | 0 | Phase 2 | NULL |
| 328 | NCT03318523 (ClinicalTrials.gov) | January 10, 2018 | 19/10/2017 | Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: BIIB054 | Biogen | NULL | Terminated | 40 Years | 80 Years | All | 357 | Phase 2 | United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom |
| 329 | EUCTR2016-003456-70-AT (EUCTR) | 04/01/2018 | 16/11/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 330 | EUCTR2017-003254-17-ES (EUCTR) | 21/12/2017 | 22/11/2017 | Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Institut de Recerca Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 4 | Spain | ||
| 331 | EUCTR2017-000087-15-DE (EUCTR) | 21/12/2017 | 17/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson's Disease with A 6-Year all- Participants-on-Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015/PRASINEZUMAB (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE WITH A 6-YEAR ALL-PARTICIPANTSON-TREATMENT EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015/PRASINEZUMAB INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 332 | EUCTR2017-003458-18-GB (EUCTR) | 19/12/2017 | 27/09/2017 | A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesia | A randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia | Parkinson's disease dyskinesia MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL790 Product Code: IRL790 INN or Proposed INN: IRL790 | Integrative Research Laboratories AB (IRLAB) | NULL | Not Recruiting | Female: yes Male: yes | 74 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Sweden | ||
| 333 | EUCTR2017-000877-35-IT (EUCTR) | 04/12/2017 | 10/11/2020 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson's Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson's Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ31-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: [JNJ31-31001074] INN or Proposed INN: Bavisant dihydrochloride monohydrate Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate | BENEVOLENTAI BIO | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 334 | NCT03944785 (ClinicalTrials.gov) | November 30, 2017 | 1/5/2019 | Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide) | A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)Tablets | Idiopathic Parkinson Disease | Drug: XADAGO (safinamide) | Supernus Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 80 Years | All | 164 | United States | |
| 335 | EUCTR2016-002033-30-GB (EUCTR) | 27/11/2017 | 05/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 336 | NCT03194217 (ClinicalTrials.gov) | November 10, 2017 | 19/6/2017 | BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness | Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD). | Excessive Daytime Sleepiness;Parkinson Disease | Drug: BEN-2001;Drug: Placebo | BenevolentAI Bio | NULL | Completed | 50 Years | 80 Years | All | 244 | Phase 2 | United States |
| 337 | NCT03305809 (ClinicalTrials.gov) | November 9, 2017 | 4/10/2017 | A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) | Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) | Lewy Body Dementia | Drug: LY3154207;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 40 Years | 85 Years | All | 344 | Phase 2 | United States;Canada;Puerto Rico;China |
| 338 | EUCTR2016-002033-30-HU (EUCTR) | 08/11/2017 | 19/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 339 | EUCTR2017-000877-35-DE (EUCTR) | 19/10/2017 | 04/09/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and effiCacy in treAtment of exceSsive daytime sleePiness (EDS) in PARkinson’s Disease (PD). CASPAR study. - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy | ||
| 340 | NCT03272165 (ClinicalTrials.gov) | October 17, 2017 | 29/6/2017 | Single Ascending Dose Study of MEDI1341 in Healthy Volunteers | A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers | Parkinson's Disease | Drug: MEDI1341;Drug: Placebo | AstraZeneca | Covance;MMS Holdings, Inc;Catalent;Takeda | Completed | 18 Years | 80 Years | All | 50 | Phase 1 | United States;United Kingdom |
| 341 | NCT03205488 (ClinicalTrials.gov) | October 16, 2017 | 28/6/2017 | Nilotinib in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease | Parkinson Disease | Drug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: Placebo | Northwestern University | University of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 79 Years | All | 76 | Phase 2 | United States |
| 342 | NCT04045678 (ClinicalTrials.gov) | October 10, 2017 | 30/7/2019 | A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 30 | Phase 1 | China |
| 343 | NCT03250117 (ClinicalTrials.gov) | October 10, 2017 | 11/8/2017 | Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole | An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa | Parkinson Disease | Drug: Ropinirole oral product;Drug: Ropinirole Implant | Titan Pharmaceuticals | NULL | Terminated | 30 Years | 80 Years | All | 3 | Phase 1/Phase 2 | United States |
| 344 | EUCTR2017-001673-17-FI (EUCTR) | 03/10/2017 | 29/08/2017 | A study to evaluate the safety and tolerability of IRL752 treatment inpatients with Parkinson's disease dementia. | A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia | Dementia in Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IRL752 INN or Proposed INN: IRL752 | Integrative Research Laboratories AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Finland;Sweden | ||
| 345 | NCT03257046 (ClinicalTrials.gov) | September 28, 2017 | 14/8/2017 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease | A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease | Parkinson Disease | Drug: ITI-214;Other: Placebo | Intra-Cellular Therapies, Inc. | NULL | Completed | 50 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
| 346 | EUCTR2015-004175-73-FI (EUCTR) | 27/09/2017 | 07/07/2016 | A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease. | A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 1;Phase 2 | Finland | ||
| 347 | NCT03295786 (ClinicalTrials.gov) | September 26, 2017 | 14/9/2017 | Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease | Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease | Parkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 17 | Phase 1/Phase 2 | Finland;Sweden |
| 348 | EUCTR2017-000128-81-DE (EUCTR) | 20/09/2017 | 06/07/2017 | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Canada;Spain;Germany | ||
| 349 | NCT03306329 (ClinicalTrials.gov) | September 13, 2017 | 25/9/2017 | DNS-7801 vs. Placebo in Parkinson's Disease | A Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson's Disease (PD) Subjects With Motor Fluctuations | Parkinson's Disease | Drug: DNS-7801 (low-dose);Drug: DNS-7801 (high dose);Drug: Placebo | Dart NeuroScience, LLC | NULL | Terminated | 30 Years | N/A | All | 5 | Phase 2 | United States |
| 350 | EUCTR2016-003961-25-CZ (EUCTR) | 07/09/2017 | 15/05/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 351 | JPRN-jRCTs041180018 | 04/09/2017 | 20/12/2018 | Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Parkinson's disease and related diseases | Two drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eye | katsuno Masahisa | NULL | Complete | >= 40age old | Not applicable | Both | 40 | Phase 2 | Japan |
| 352 | ChiCTR-INR-17012013 | 2017-09-01 | 2017-07-17 | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease | Parkinson‘s disease, Depression | BTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection; | Shanghai Tongji Hospital, Tongji University | NULL | Pending | 18 | 80 | Both | BTX-A:40;Placebo:40; | China | |
| 353 | EUCTR2017-000128-81-ES (EUCTR) | 28/08/2017 | 12/07/2017 | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: PF-06649751 - 1mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 5mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 Product Code: PF-06649751 - 15mg INN or Proposed INN: Not yet assigned Other descriptive name: PF-06649751 | Pfizer Inc., 235 East 42nd Street, New York, New York | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Canada;Spain;Germany | ||
| 354 | NCT03292016 (ClinicalTrials.gov) | August 22, 2017 | 11/9/2017 | A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by OFF Episodes | A Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277;Drug: APO-go;Drug: Apokyn | Sunovion | NULL | Completed | 18 Years | N/A | All | 8 | Phase 2 | United States |
| 355 | EUCTR2017-000087-15-AT (EUCTR) | 17/08/2017 | 18/05/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015/PRASINEZUMAB (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON'S DISEASE WITH A 6-YEAR ALL-PARTICIPANTSONTREATMENT EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 356 | NCT04162275 (ClinicalTrials.gov) | August 15, 2017 | 22/9/2019 | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects | A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects | Parkinson Disease | Drug: Finamine tablets;Drug: Placebo tablets | Yiling Pharmaceutical Inc. | NULL | Completed | 18 Years | 65 Years | All | 34 | Phase 1 | China |
| 357 | NCT03204929 (ClinicalTrials.gov) | August 14, 2017 | 28/6/2017 | Dose Escalation Study of Cu(II)ATSM in Parkinson's Disease | A Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Cu(II)ATSM | Collaborative Medicinal Development Pty Limited | NULL | Completed | 30 Years | N/A | All | 31 | Phase 1 | Australia |
| 358 | EUCTR2017-000877-35-CZ (EUCTR) | 09/08/2017 | 05/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 359 | EUCTR2017-000877-35-GB (EUCTR) | 08/08/2017 | 17/07/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 360 | EUCTR2017-000877-35-ES (EUCTR) | 03/08/2017 | 09/06/2017 | A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease. | Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) | Excessive daytime sleepiness with Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE Product Name: Bavisant Product Code: JNJ-31001074 INN or Proposed INN: Bavisant dihydrochloride monohydrate Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE | BenevolentAI Bio | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy | ||
| 361 | NCT03187301 (ClinicalTrials.gov) | August 3, 2017 | 7/6/2017 | A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF Episodes | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson's Disease;Off Episodes of Parkinson Disease | Drug: APL-130277;Drug: Placebo;Drug: Moxifloxacin | Sunovion | NULL | Completed | 18 Years | N/A | All | 48 | Phase 2 | United States;Italy |
| 362 | EUCTR2014-004865-26-GR (EUCTR) | 01/08/2017 | 25/04/2017 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden | ||
| 363 | EUCTR2017-000087-15-FR (EUCTR) | 27/07/2017 | 30/10/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;France;Spain;Austria;Germany | ||
| 364 | EUCTR2017-000087-15-ES (EUCTR) | 26/07/2017 | 08/06/2017 | A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena) | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: aSyn Mab Product Code: RO7046015 INN or Proposed INN: N/A Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;United States;Spain;Austria;Germany | ||
| 365 | NCT03026231 (ClinicalTrials.gov) | July 15, 2017 | 11/1/2017 | Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients | A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease | Parkinson's Disease | Biological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727) | The University of Texas Health Science Center, Houston | Kelsey Research Foundation | Withdrawn | 45 Years | 70 Years | All | 0 | Phase 1/Phase 2 | United States |
| 366 | EUCTR2017-000262-30-IT (EUCTR) | 10/07/2017 | 04/11/2020 | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA | Parkinson's Desease (PD) MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: EXN-44(LEVODOPA) Product Code: EXN-44 Trade Name: Sinemet Product Name: EXN-32 (CARBIDOPA E LEVODOPA) Product Code: EXN-32 | DR. REDDY’S LABORATORIES LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 367 | EUCTR2017-000135-14-ES (EUCTR) | 07/07/2017 | 09/06/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;Italy;United Kingdom | ||
| 368 | NCT03185481 (ClinicalTrials.gov) | July 6, 2017 | 9/6/2017 | Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease With Motor Fluctuations | Drug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD | Pfizer | NULL | Terminated | 40 Years | 87 Years | All | 5 | Phase 2 | United States |
| 369 | NCT03162874 (ClinicalTrials.gov) | July 4, 2017 | 19/5/2017 | Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) | Parkinson Disease | Drug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2 | Prexton Therapeutics | NULL | Completed | 35 Years | 85 Years | All | 157 | Phase 2 | Austria;France;Germany;Italy;Spain;United Kingdom |
| 370 | NCT03288155 (ClinicalTrials.gov) | July 1, 2017 | 15/9/2017 | Can a Flavonoid-rich Pure Cocoa Reduce Fatigue in People With Parkinson's (PD) | A Study to Determine Whether the Daily Consumption of Flavonoid-rich Pure Cocoa Can Reduce Fatigue in People With Parkinson's (PD) | Parkinson Disease;Fatigue | Dietary Supplement: Cocoa | Oxford Brookes University | European Parkinson Therapy Centre | Completed | 18 Years | N/A | All | 30 | N/A | Italy |
| 371 | EUCTR2016-003961-25-DE (EUCTR) | 30/06/2017 | 01/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 372 | NCT03100149 (ClinicalTrials.gov) | June 27, 2017 | 29/3/2017 | A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension | Parkinson's Disease | Drug: RO7046015;Drug: Placebo | Hoffmann-La Roche | Prothena Biosciences Limited | Active, not recruiting | 40 Years | 80 Years | All | 316 | Phase 2 | United States;Austria;France;Germany;Spain |
| 373 | NCT03195231 (ClinicalTrials.gov) | June 25, 2017 | 20/6/2017 | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease | Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial. | Antidepressive Agents | Drug: Wuling Powder;Drug: Placebo | Beijing Hospital | Tongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical University | Not yet recruiting | 40 Years | N/A | All | 120 | Phase 4 | NULL |
| 374 | EUCTR2017-000135-14-GB (EUCTR) | 15/06/2017 | 17/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 375 | EUCTR2016-003961-25-ES (EUCTR) | 08/06/2017 | 27/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 376 | EUCTR2017-000135-14-DE (EUCTR) | 06/06/2017 | 10/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;Italy;United Kingdom | ||
| 377 | EUCTR2016-003961-25-HU (EUCTR) | 31/05/2017 | 03/04/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom | ||
| 378 | EUCTR2017-000135-14-IT (EUCTR) | 30/05/2017 | 04/11/2020 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | Studio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax | PREXTON THERAPEUTICS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 379 | EUCTR2017-000135-14-AT (EUCTR) | 26/05/2017 | 08/03/2017 | A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug Levodopa | A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E Product Name: foliglurax Product Code: PXT002331 INN or Proposed INN: foliglurax Other descriptive name: CVD00118-E | Prexton Therapeutics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 380 | NCT03033498 (ClinicalTrials.gov) | May 17, 2017 | 25/1/2017 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease | A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 45 Years | 85 Years | All | 29 | Phase 1 | United States |
| 381 | NCT03065192 (ClinicalTrials.gov) | May 11, 2017 | 10/2/2017 | Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease | An Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Using a Posterior Trajectory Into the Putamen of Participants With Parkinson's Disease With Fluctuating Responses to Levodopa | Idiopathic Parkinson's Disease;Parkinson's Disease;Basal Ganglia Disease;Brain Diseases;Central Nervous System Diseases;Movement Disorders;Nervous System Diseases;Neurodegenerative Diseases;Parkinsonian Disorders | Drug: VY-AADC01 | Neurocrine Biosciences | Voyager Therapeutics | Completed | 40 Years | 75 Years | All | 16 | Phase 1 | United States |
| 382 | NCT03047629 (ClinicalTrials.gov) | May 11, 2017 | 3/2/2017 | Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation | A Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related Constipation | Parkinson's Disease;Constipation | Drug: ENT-01;Other: Placebo | Enterin Inc. | NULL | Completed | 30 Years | 86 Years | All | 50 | Phase 1/Phase 2 | United States |
| 383 | EUCTR2015-004507-23-FI (EUCTR) | 08/05/2017 | 30/03/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 384 | NCT03119636 (ClinicalTrials.gov) | May 2017 | 6/4/2017 | Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease | A Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's Disease | Parkinson's Disease | Biological: NPC transplantation;Drug: Levodopa | Chinese Academy of Sciences | The First Affiliated Hospital of Zhengzhou University | Recruiting | 50 Years | 80 Years | All | 50 | Phase 1/Phase 2 | China |
| 385 | NCT02702076 (ClinicalTrials.gov) | May 2017 | 2/3/2016 | Apomorphine in Parkinson's Disease Patients With Visual Hallucinations | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations | Parkinson's Disease;Hallucinations, Visual | Drug: Apomorphine;Drug: Placebo | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 35 | Phase 2 | Netherlands |
| 386 | ChiCTR-IPR-17011155 | 2017-04-20 | 2017-04-16 | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease | Parkinson’s disease | treatment group:dihydroergotoxine mesylate 2.5 mg, twice daily, two weeks;intervention group:identical placebo 2.5 mg, twice daily, two weeks; | Nanjing First Hospital Affiliated to Nanjing Medical University | NULL | Recruiting | 18 | 80 | Both | treatment group:10;intervention group:10; | China | |
| 387 | NCT03128450 (ClinicalTrials.gov) | April 15, 2017 | 9/2/2017 | A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient | A Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease | Parkinson Disease | Biological: human neural stem cell | Second Affiliated Hospital of Soochow University | NULL | Enrolling by invitation | 35 Years | 70 Years | All | 12 | Phase 2/Phase 3 | China |
| 388 | NCT03051607 (ClinicalTrials.gov) | April 10, 2017 | 9/2/2017 | Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off | Idiopathic Parkinson Disease | Drug: Tozadenant | Biotie Therapies Inc. | Acorda Therapeutics | Terminated | 30 Years | 80 Years | All | 66 | Phase 3 | United States;Canada;United Kingdom |
| 389 | JPRN-jRCTs051180185 | 07/04/2017 | 26/03/2019 | APISJ Study | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study | Parkinson's disease Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline. | Takahashi Makio | Kyowa Kirin Co., Ltd. | Complete | >= 30age old | Not applicable | Both | 30 | N/A | Japan |
| 390 | EUCTR2016-003961-25-GB (EUCTR) | 04/04/2017 | 16/02/2017 | A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing off | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” | Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: tozadenant Product Code: TOZ INN or Proposed INN: tozadenant Other descriptive name: TOZADENANT | Biotie Therapies | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom | ||
| 391 | EUCTR2016-001403-23-GR (EUCTR) | 31/03/2017 | 14/10/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 392 | NCT02970019 (ClinicalTrials.gov) | March 30, 2017 | 18/11/2016 | Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease | A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706. | Parkinson Disease | Drug: K0706;Drug: Placebo | Sun Pharma Advanced Research Company Limited | NULL | Completed | 18 Years | 65 Years | All | 60 | Phase 1 | United States |
| 393 | EUCTR2016-003456-70-GB (EUCTR) | 22/03/2017 | 26/01/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorp | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;Italy;United Kingdom | ||
| 394 | EUCTR2016-001575-71-ES (EUCTR) | 16/03/2017 | 17/01/2017 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 395 | JPRN-UMIN000026492 | 2017/03/15 | 15/03/2017 | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Osaka Red Cross Hospital | Clinical Research Center, Wakayama Medical University | Complete: follow-up complete | 30years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 396 | EUCTR2015-003513-24-SK (EUCTR) | 14/03/2017 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 397 | JPRN-jRCTs071180014 | 08/03/2017 | 29/01/2019 | ODYSSEI Study | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study | Parkinson's disease Parkinson's disease | Arm A: Treatment with Istradefylline combined with optimal medical therapy. Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient. Arm B: Optimal medical therapy without Istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient. | Tsuboi Yoshio | Kyowa Kirin Co., Ltd. | Not Recruiting | >= 30age old | < 80age old | Both | 280 | N/A | N A;Japan |
| 398 | EUCTR2015-004507-23-HU (EUCTR) | 24/02/2017 | 04/01/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 399 | EUCTR2016-001403-23-FI (EUCTR) | 22/02/2017 | 31/08/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 400 | EUCTR2016-000657-12-IT (EUCTR) | 16/02/2017 | 08/02/2017 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 000000 Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: 00000 Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 401 | NCT03119194 (ClinicalTrials.gov) | January 27, 2017 | 13/4/2017 | Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 | An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male Subjects | Parkinson Disease | Drug: [14C]-BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 30 Years | 65 Years | Male | 7 | Phase 1 | United Kingdom |
| 402 | EUCTR2016-000657-12-DE (EUCTR) | 26/01/2017 | 17/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 403 | EUCTR2016-000657-12-PT (EUCTR) | 09/01/2017 | 25/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Germany;Norway;Japan;Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Sweden | ||
| 404 | ChiCTR-DDD-16009569 | 2017-01-01 | 2016-10-24 | Differential diagnosis of primary Parkinson's disease by 18F-FDG combined with 11C-ß-CFT PET / CT imaging | Differential diagnosis of primary Parkinson's disease by 18F-FDG combined with 11C-ß-CFT PET / CT imaging | Parkinson's Disease | Gold Standard:;Index test:; | Renji hospital, School of Medicine, Shanghai Jiao Tong University | NULL | Pending | 20 | 80 | Both | Target condition:0;Difficult condition:0 | China | |
| 405 | NCT02954978 (ClinicalTrials.gov) | January 2017 | 1/11/2016 | Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | Parkinson Disease;Parkinsons Disease With Dementia | Drug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna] | Georgetown University | NULL | Active, not recruiting | 40 Years | 90 Years | All | 75 | Phase 2 | United States |
| 406 | NCT02969369 (ClinicalTrials.gov) | December 31, 2016 | 17/11/2016 | A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis | A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis | Parkinson Disease Psychosis | Drug: SEP-363856;Drug: Placebo capsule | Sunovion | NULL | Completed | 55 Years | 105 Years | All | 39 | Phase 2 | United States |
| 407 | EUCTR2016-001575-71-DE (EUCTR) | 23/12/2016 | 26/09/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASE | A 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | France;United States;Spain;Israel;Germany | ||
| 408 | EUCTR2016-002033-30-BE (EUCTR) | 19/12/2016 | 21/11/2016 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 409 | NCT02906020 (ClinicalTrials.gov) | December 15, 2016 | 14/9/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant. | Parkinson's Disease | Drug: venglustat GZ/SAR402671;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | 80 Years | All | 270 | Phase 2 | United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom |
| 410 | JPRN-UMIN000024859 | 2016/12/14 | 16/11/2016 | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | Parkinson's disease | Switching from Dopamine agonist to Zonisamide. Intervention period of 12 weeks. | Medical Corporation Abe Neurology Clinic | NULL | Complete: follow-up continuing | 30years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 411 | NCT02941822 (ClinicalTrials.gov) | December 2016 | 5/9/2016 | Ambroxol in Disease Modification in Parkinson Disease | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease | Parkinson Disease | Drug: Ambroxol | University College, London | The Cure Parkinson's Trust | Completed | 40 Years | 80 Years | All | 23 | Phase 2 | United Kingdom |
| 412 | NCT02879136 (ClinicalTrials.gov) | December 2016 | 23/6/2016 | TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease | TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study | Parkinson's Disease, Idiopathic | Drug: Methylphenidate;Other: Physical Therapy;Drug: Atomoxetine | Hubert Fernandez | NULL | Recruiting | 18 Years | 90 Years | All | 42 | Early Phase 1 | United States |
| 413 | NCT03000569 (ClinicalTrials.gov) | November 30, 2016 | 28/11/2016 | A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease | A Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s) | Sage Therapeutics | NULL | Completed | 40 Years | 75 Years | All | 29 | Phase 2 | United States |
| 414 | EUCTR2016-001403-23-SK (EUCTR) | 29/11/2016 | 07/09/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;European Union;Slovakia;Greece;Finland;Spain | ||
| 415 | EUCTR2016-002033-30-FR (EUCTR) | 29/11/2016 | 12/01/2017 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden | ||
| 416 | JPRN-UMIN000024536 | 2016/11/28 | 25/10/2016 | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) | Parkinson's disease | Treatment with istradefylline combined with optimal medical therapy. Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient. Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient. | Fukuoka University | NULL | Complete: follow-up complete | 30years-old | 80years-old | Male and Female | 280 | Not applicable | Japan |
| 417 | EUCTR2015-004912-39-ES (EUCTR) | 25/11/2016 | 17/05/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson's Disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| 418 | EUCTR2016-000102-11-NL (EUCTR) | 23/11/2016 | 08/11/2016 | Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. | Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT | Parkinson's disease patients with refractory visual hallucinations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | |||
| 419 | NCT03007888 (ClinicalTrials.gov) | November 14, 2016 | 6/12/2016 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: IR CD-LD;Drug: ER CD-LD | Impax Laboratories, LLC | NULL | Completed | 40 Years | 100 Years | All | 28 | Phase 2 | United States |
| 420 | EUCTR2016-001403-23-ES (EUCTR) | 14/11/2016 | 15/11/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 421 | EUCTR2016-000657-12-SE (EUCTR) | 09/11/2016 | 12/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU Product Name: Venglustat Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: venglustat malate Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden | ||
| 422 | NCT03531060 (ClinicalTrials.gov) | November 8, 2016 | 10/4/2018 | A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia | A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID). | Parkinson Disease | Drug: IRL790;Drug: Placebo | Integrative Research Laboratories AB | NULL | Completed | 50 Years | 85 Years | All | 15 | Phase 1/Phase 2 | NULL |
| 423 | EUCTR2016-002033-30-ES (EUCTR) | 03/11/2016 | 25/08/2016 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden | ||
| 424 | JPRN-UMIN000025638 | 2016/11/01 | 16/01/2017 | Adenosine A2A receptors in Parkinson's disease | Adenosine A2A receptors in Parkinson's disease - Adenosine A2A receptors in Parkinson's disease | Parkinson's disease | 11C-preladenant-PET scanning | Tokyo Metropolitan Institute of Gerontology | NULL | Complete: follow-up complete | 40years-old | 89years-old | Male and Female | 40 | Not selected | Japan |
| 425 | NCT03022799 (ClinicalTrials.gov) | November 2016 | 27/12/2016 | Phase I, KM-819 in Healthy Subjects for Parkinson's Disease | A First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly Subjects | Parkinson's Disease | Drug: KM-819;Drug: Placebo | Kainos Medicine Inc. | NULL | Completed | 19 Years | 45 Years | All | 88 | Phase 1 | Korea, Republic of |
| 426 | NCT02857244 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | Parkinson's Disease | Drug: Duloxetine;Drug: Donepezil;Drug: Modafinil | University of Chicago | NULL | Withdrawn | 18 Years | 100 Years | All | 0 | Phase 2 | United States |
| 427 | EUCTR2016-000657-12-ES (EUCTR) | 20/10/2016 | 24/10/2016 | A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation | Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD | Parkinson's disease (PD) carrying a GBA mutation MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU Product Code: SAR402671, GZ402671 or GZ/SAR402671 INN or Proposed INN: NA Other descriptive name: Genz-682452-AU | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 276 | Phase 2 | United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden | ||
| 428 | NCT02847650 (ClinicalTrials.gov) | October 17, 2016 | 25/7/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 | Pfizer | NULL | Terminated | 45 Years | 80 Years | All | 57 | Phase 2 | United States;France;Germany;Israel |
| 429 | EUCTR2015-002571-24-GB (EUCTR) | 14/10/2016 | 12/02/2019 | A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. | A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AMBROSAN 60mg Tablets Product Name: Ambroxol INN or Proposed INN: Ambroxol hydrochloride | Joint Research Office | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 430 | EUCTR2016-002391-27-GB (EUCTR) | 07/10/2016 | 04/08/2016 | Opicapone in clinical practice (OPTIPARK) | This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 | Parkinson's disease (PD) patients with wearing-off motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom | ||
| 431 | EUCTR2016-002391-27-DE (EUCTR) | 05/10/2016 | 05/08/2016 | OPTIPARK | Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations | Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specify | Trade Name: Ongentys Product Name: Ongentys | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom | ||
| 432 | NCT02538315 (ClinicalTrials.gov) | October 2016 | 25/8/2015 | Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients | Using 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease Patients | Parkinson`s Disease | Drug: [18F]FDOPA PET/CT | University of Saskatchewan | University of Manitoba | Recruiting | 18 Years | N/A | All | 30 | N/A | Canada |
| 433 | NCT02818777 (ClinicalTrials.gov) | October 2016 | 6/5/2016 | A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease | Parkinson's Disease | Drug: cannabidiol | University of Colorado, Denver | Colorado Department of Public Health and Environment;GW Research Ltd | Completed | 40 Years | 80 Years | All | 13 | Phase 2 | United States |
| 434 | NCT02803749 (ClinicalTrials.gov) | October 2016 | 14/6/2016 | Buspirone in Parkinson's Disease | The Tolerability of Buspirone for the Treatment of Anxiety in Parkinson's Disease | Parkinson Disease;Anxiety | Drug: Buspirone;Drug: Placebo | University of Rochester | Michael J. Fox Foundation for Parkinson's Research | Completed | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 435 | EUCTR2015-005078-39-DE (EUCTR) | 21/09/2016 | 02/03/2016 | - | A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease | Subjects with advanced Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 436 | EUCTR2016-001403-23-IT (EUCTR) | 13/09/2016 | 06/09/2021 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease. | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa Product Name: na Product Code: [na] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy | ||
| 437 | EUCTR2015-003513-24-DE (EUCTR) | 08/09/2016 | 15/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 438 | NCT02601586 (ClinicalTrials.gov) | September 2016 | 17/8/2015 | Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease | Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial | Parkinson Disease | Drug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placebo | University Hospital, Toulouse | NULL | Completed | 40 Years | 75 Years | All | 67 | Phase 2/Phase 3 | France |
| 439 | NCT02782481 (ClinicalTrials.gov) | August 2016 | 22/5/2016 | A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor Fluctuations | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Withdrawn | 30 Years | 80 Years | All | 0 | Phase 3 | Israel |
| 440 | NCT02365870 (ClinicalTrials.gov) | August 2016 | 11/2/2015 | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment | Anxiety Disorders;Parkinson Disease | Drug: rotigotine transdermal patch;Drug: placebo | Johns Hopkins University | National Institute on Aging (NIA) | Terminated | 21 Years | 89 Years | All | 4 | Phase 4 | United States |
| 441 | NCT02382198 (ClinicalTrials.gov) | July 2016 | 21/1/2015 | Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease | A Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's Disease | Sialorrhea;Parkinson's Disease | Drug: Glycopyrrolate;Drug: Placebo | Ottawa Hospital Research Institute | NULL | Unknown status | 30 Years | N/A | All | 28 | Phase 2 | Canada |
| 442 | NCT02452723 (ClinicalTrials.gov) | July 2016 | 18/5/2015 | A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's Disease | A Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's Disease | Parkinson Disease | Biological: ISC-hpNSC | Cyto Therapeutics Pty Limited | NULL | Active, not recruiting | 30 Years | 70 Years | All | 12 | Phase 1 | Australia |
| 443 | NCT02615873 (ClinicalTrials.gov) | July 2016 | 23/11/2015 | A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 | An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | 100 Years | All | 460 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom |
| 444 | NCT02789592 (ClinicalTrials.gov) | July 2016 | 31/5/2016 | Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease | A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placebo | Seoul National University Hospital | Kuhnil Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | N/A | Both | 30 | Phase 2 | Korea, Republic of |
| 445 | EUCTR2015-003513-24-BG (EUCTR) | 27/06/2016 | 26/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 446 | EUCTR2015-003513-24-IT (EUCTR) | 23/06/2016 | 05/11/2020 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 447 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 448 | EUCTR2015-004912-39-DE (EUCTR) | 14/06/2016 | 11/02/2016 | A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 Product Name: PF-06649751 Product Code: PF-06649751 INN or Proposed INN: PF-06649751 Other descriptive name: PF-06649751 | Pfizer, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | France;United States;Spain;Germany;Japan;United Kingdom | ||
| 449 | EUCTR2015-005078-39-IT (EUCTR) | 08/06/2016 | 19/01/2021 | NA | A multicenter, parallel-group, rater-blinded, randomized clinical studyinvestigating the efficacy, safety, tolerability and pharmacokinetics of2 dosing regimens of ND0612H, a solution of levodopa/carbidopadelivered via a pump system as a continuous subcutaneous infusion insubjects with advanced Parkinson's disease - NA | advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 450 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 451 | JPRN-UMIN000022533 | 2016/06/01 | 01/06/2016 | A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease | A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease - The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease(DATSZ-PD study) | Parkinson's disease | L-Dopa/DCI only The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + selegiline L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + zonisamide L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365. | Osaka Redcross HospitalWakayama Prefectural Medical College | NULL | Recruiting | 55years-old | 80years-old | Male and Female | 180 | Phase 2 | Japan |
| 452 | NCT02785978 (ClinicalTrials.gov) | June 2016 | 11/5/2016 | Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers | Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers | Parkinson Disease;Healthy Volunteers | Drug: Levodopa acute challenge;Other: Controlled environment tests (series of tasks of everyday life);Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS;Device: ActiMyo recording;Other: Diary completion | Institut de Myologie, France | NULL | Completed | 18 Years | N/A | All | 30 | N/A | France |
| 453 | NCT02807675 (ClinicalTrials.gov) | June 2016 | 17/6/2016 | A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder) | A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301, LIP;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 36 | Phase 1 | United States |
| 454 | NCT02642393 (ClinicalTrials.gov) | June 2016 | 19/12/2015 | Study of Urate Elevation in Parkinson's Disease, Phase 3 | A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's Disease | Parkinson's Disease | Drug: Inosine;Drug: Placebo | Michael Alan Schwarzschild | The Parkinson Study Group;Michael J. Fox Foundation for Parkinson's Research;University of Rochester;National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 30 Years | N/A | All | 298 | Phase 3 | United States;Puerto Rico |
| 455 | NCT02812394 (ClinicalTrials.gov) | June 2016 | 22/6/2016 | A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets | A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets | Parkinson Disease | Drug: CVT-301 (Dose Level 1);Drug: CVT-301 (Dose Level 2);Drug: Sinemet® | Acorda Therapeutics | NULL | Completed | 25 Years | 65 Years | Both | 24 | Phase 1 | United States |
| 456 | EUCTR2016-000679-25-ES (EUCTR) | 31/05/2016 | 18/03/2016 | Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease. | A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study. | Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Parapres | INSTITUT DE RECERCA HSCSP | NULL | Not Recruiting | Female: yes Male: yes | 56 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain | ||
| 457 | JPRN-UMIN000009062 | 2016/05/30 | 09/10/2012 | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease - An evaluation of the safety of inosine for patients with Parkinson's disease | Parkinson's disease | Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL | Dept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 1 | Japan |
| 458 | EUCTR2015-005078-39-AT (EUCTR) | 30/05/2016 | 09/03/2016 | - | A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease | Subjects with advanced Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 459 | EUCTR2015-003513-24-HU (EUCTR) | 24/05/2016 | 02/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 460 | EUCTR2015-003513-24-ES (EUCTR) | 18/05/2016 | 18/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 461 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 462 | EUCTR2016-000637-43-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 463 | EUCTR2016-000636-18-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunuvion Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 3 | Canada;United States;United Kingdom | ||
| 464 | JPRN-UMIN000022023 | 2016/05/10 | 10/05/2016 | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- | Parkinson diseaseChronic constipation | Study drug group: A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollmen | Dokkyo Medical University | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 64 | Not selected | Japan |
| 465 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 466 | EUCTR2015-003887-34-PL (EUCTR) | 06/05/2016 | 26/02/2016 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 467 | NCT02784145 (ClinicalTrials.gov) | May 2016 | 17/5/2016 | Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease | Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease | Parkinson Disease | Dietary Supplement: Resistant starch;Other: Recommendation with regard to nutrition | Saarland University | NULL | Completed | 18 Years | N/A | All | 95 | N/A | Germany |
| 468 | NCT02705755 (ClinicalTrials.gov) | May 2016 | 7/3/2016 | TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) | A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension | Neurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic Hypotension | Drug: TD-9855;Drug: Placebo | Theravance Biopharma | NULL | Completed | 40 Years | N/A | All | 34 | Phase 2 | United States |
| 469 | NCT02728947 (ClinicalTrials.gov) | May 2016 | 31/3/2016 | Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | A Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's Disease | Parkinson's Disease | Drug: ROTIGOTINE | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 99 Years | Both | 28 | Phase 1 | United States |
| 470 | EUCTR2015-003513-24-GB (EUCTR) | 28/04/2016 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 471 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 472 | EUCTR2015-004507-23-DE (EUCTR) | 25/04/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 473 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 474 | EUCTR2015-003887-34-DE (EUCTR) | 12/04/2016 | 23/12/2015 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 475 | EUCTR2014-005630-60-AT (EUCTR) | 12/04/2016 | 04/12/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 476 | NCT02764125 (ClinicalTrials.gov) | April 8, 2016 | 13/1/2016 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC) | Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off | Parkinson's Disease | Drug: Stalevo;Drug: levodopa MR | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | All | 84 | Phase 2 | Finland;Germany;Hungary;Latvia |
| 477 | NCT03034538 (ClinicalTrials.gov) | April 8, 2016 | 25/1/2017 | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | Parkinson Disease;Parkinsonism;Dyskinesias | Drug: Zonegran | The Cooper Health System | NULL | Suspended | 18 Years | N/A | All | 20 | Phase 4 | United States |
| 478 | NCT02719496 (ClinicalTrials.gov) | April 2016 | 15/3/2016 | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Gastrointestinal Disorders in Parkinson's Disease | Drug: IBEROGAST | Nantes University Hospital | NULL | Completed | 30 Years | 80 Years | All | 45 | Phase 2 | France |
| 479 | EUCTR2015-003887-34-IT (EUCTR) | 25/03/2016 | 21/01/2021 | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s Disease - A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinso | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | KYOWA HAKKO KIRIN PHARMA, INC. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 480 | JPRN-jRCTs061180060 | 22/03/2016 | 18/03/2019 | Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease;D010300 | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) | Nagai Masahiro | NULL | Complete | >= 20age old | Not applicable | Both | 100 | Phase 2 | Japan |
| 481 | EUCTR2015-004507-23-LV (EUCTR) | 15/03/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC | Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Finland;Germany;Latvia | ||
| 482 | EUCTR2015-004129-15-ES (EUCTR) | 07/03/2016 | 24/02/2016 | Subjects participating in a Parkinson Disease cohort are offered to undergo a PET imaging scan requiring an intravenous diagnostic drug (florbetaben) with the aim of identifying markers of disease progression | Evaluation of [18F] florbetaben in subjects participating in the Parkinson?s Progression Markers Initiative (PPMI) Protocol | Parkinson's Disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neuraceq Product Name: 18F florbetaben INN or Proposed INN: FLORBETABEN (18F) | Institute for Neurodegenerative Disorders | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Spain | |||
| 483 | NCT02687542 (ClinicalTrials.gov) | March 3, 2016 | 29/1/2016 | Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations | A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE | Parkinson Disease | Drug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD) | Pfizer | NULL | Terminated | 40 Years | 85 Years | All | 108 | Phase 2 | United States;Canada;France;Germany;Japan;Spain |
| 484 | EUCTR2015-003887-34-CZ (EUCTR) | 02/03/2016 | 30/12/2015 | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease | Moderate to severe Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 485 | NCT02668497 (ClinicalTrials.gov) | March 2016 | 26/1/2016 | Kinematic-based BoNT-A Bilateral Upper Limb PD Therapy | Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy | Parkinson's Disease | Drug: Botulinum Toxin Type A | Western University, Canada | NULL | Active, not recruiting | 18 Years | 80 Years | All | 50 | Phase 2 | Canada |
| 486 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 487 | NCT02618941 (ClinicalTrials.gov) | February 2, 2016 | 25/11/2015 | Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA) | Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 Program | Parkinson's Disease | Biological: AFFITOPE® PD01A | Affiris AG | NULL | Completed | 40 Years | 68 Years | All | 26 | Phase 1 | Austria |
| 488 | JPRN-UMIN000020527 | 2016/02/01 | 01/02/2016 | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Parkinson's disease | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years | Ehime University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Phase 2 | Japan |
| 489 | JPRN-UMIN000020288 | 2016/02/01 | 28/12/2015 | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. - Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Juntendo University Shizuoka Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 490 | NCT02641054 (ClinicalTrials.gov) | February 2016 | 7/12/2015 | Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease | Double-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge Test | Idiopathic Parkinson Disease | Drug: CVXL-0107;Drug: Placebo;Drug: Levodopa | CleveXel Pharma | NULL | Completed | 40 Years | 75 Years | All | 21 | Phase 2 | France |
| 491 | JPRN-JapicCTI-153112 | 22/1/2016 | 25/12/2015 | ONO-2370 Phase 2 study(ONO-2370-02) | ONO-2370 a Phase 2 Double-Blind, Randomised, Placebo-Controlled, Parallel-Group study, and an Open-Label, Uncontrolled, Multicenter, Long-term, Extension study(ONO-2370-02) | Parkinson's disease | Intervention name : ONO-2370 INN of the intervention : Opicapone Dosage And administration of the intervention : ONO-2370 once-daily Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Once-daily placebo equivalent to active control | ONO PHARMACEUTICAL CO.,LTD. | NULL | complete | 30 | 83 | BOTH | 399 | Phase 2 | Japan |
| 492 | NCT02649608 (ClinicalTrials.gov) | January 2016 | 6/1/2016 | An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients | Interventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's Disease | Parkinson Disease | Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621;Drug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621 | H. Lundbeck A/S | NULL | Completed | 45 Years | 75 Years | All | 15 | Phase 1 | United States |
| 493 | NCT02579473 (ClinicalTrials.gov) | January 2016 | 13/10/2015 | A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214 | A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration | Parkinson's Disease | Drug: SER-214 | Serina Therapeutics | NULL | Active, not recruiting | 40 Years | 80 Years | All | 20 | Phase 1 | United States |
| 494 | NCT02639221 (ClinicalTrials.gov) | January 2016 | 17/12/2015 | A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects | PXT002331 A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects | Parkinson's Disease | Drug: PXT002331 | Prexton Therapeutics | NULL | Completed | 18 Years | 60 Years | Both | 64 | Phase 1 | United Kingdom |
| 495 | EUCTR2014-002600-24-AT (EUCTR) | 30/12/2015 | 25/09/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 496 | EUCTR2014-002600-24-IT (EUCTR) | 11/12/2015 | 16/02/2018 | Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: Safinamide Product Code: na INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO Trade Name: Xadago INN or Proposed INN: SAFINAMIDE METANSOLFONATO Other descriptive name: SAFINAMIDE METANSOLFONATO | ZAMBON SPA | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 497 | EUCTR2014-005630-60-ES (EUCTR) | 11/12/2015 | 05/10/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD | Parkinson´s Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 498 | EUCTR2014-002600-24-SE (EUCTR) | 03/12/2015 | 30/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 499 | NCT02610231 (ClinicalTrials.gov) | December 2015 | 13/11/2015 | Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 20 mg or 40 mg | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 239 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 500 | EUCTR2014-002600-24-ES (EUCTR) | 19/11/2015 | 05/10/2015 | Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide INN or Proposed INN: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 501 | NCT02565628 (ClinicalTrials.gov) | November 16, 2015 | 28/9/2015 | PF-06669571 In Subjects With Idiopathic Parkinson's Disease | A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease. | Idiopathic Parkinson's Disease | Drug: PF-06669571;Drug: Placebo | Pfizer | NULL | Completed | N/A | N/A | All | 20 | Phase 1 | United States |
| 502 | EUCTR2015-000148-40-GB (EUCTR) | 09/11/2015 | 16/09/2015 | A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease. | Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT) | Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: Simvastatin | Plymouth Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 503 | JPRN-UMIN000019654 | 2015/11/06 | 06/11/2015 | The effect of rich-hydrogen water drinking to gut peptide | The effect of rich-hydrogen water drinking to gut peptide - The effect of rich-hydrogen water drinking to gut peptide | Parkinson's disease, healthy control | hydrogen water natural water | Nagoya graduate school of medicine university | NULL | Pending | 20years-old | 80years-old | Male and Female | 40 | Not applicable | Japan |
| 504 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 505 | EUCTR2014-002600-24-GB (EUCTR) | 03/11/2015 | 28/07/2015 | Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complications | A TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST | Idiopathic Parkinson's Disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE Trade Name: Xadago Product Name: safinamide Other descriptive name: SAFINAMIDE | Zambon S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 556 | Phase 3 | France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 506 | NCT04110678 (ClinicalTrials.gov) | November 1, 2015 | 18/9/2019 | Tolerance to NeuroEPO in Parkinson Disease | Nasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead Trial | Parkinson Disease | Drug: NeuroEPO | International Center for Neurological Restoration, Cuba | Center of Molecular Immunology, Cuba;University of Electronic Science and Technology of China | Completed | 40 Years | 70 Years | All | 26 | Phase 1/Phase 2 | Cuba |
| 507 | NCT02271503 (ClinicalTrials.gov) | November 2015 | 13/10/2014 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease | A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease | Parkinson's Disease | Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 26 | Phase 2 | United States |
| 508 | NCT02577523 (ClinicalTrials.gov) | November 2015 | 6/10/2015 | A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease | A Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease | Parkinson's Disease | Drug: ND0612 (Levodopa/Carbidopa solution) | NeuroDerm Ltd. | NULL | Completed | 30 Years | 80 Years | All | 38 | Phase 2 | United States;Austria;Israel;Italy |
| 509 | NCT02758730 (ClinicalTrials.gov) | November 2015 | 26/4/2016 | Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA Patients | A Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBA | Parkinson's Disease | Biological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | University Hospital Tuebingen | Withdrawn | 40 Years | 80 Years | Both | 0 | Phase 1 | Germany |
| 510 | EUCTR2014-005630-60-DE (EUCTR) | 29/10/2015 | 07/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 511 | NCT02549092 (ClinicalTrials.gov) | October 26, 2015 | 11/9/2015 | A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study | Advanced Parkinson's Disease | Drug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 89 | Phase 3 | United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden |
| 512 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 513 | NCT02562768 (ClinicalTrials.gov) | September 30, 2015 | 28/9/2015 | A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease | Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease | Parkinson's Disease | Drug: LY3154207;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 20 Years | N/A | All | 80 | Phase 1 | United States |
| 514 | EUCTR2014-005630-60-CZ (EUCTR) | 23/09/2015 | 10/07/2015 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD | Parkinson’s Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 INN or Proposed INN: Tozadenant Other descriptive name: TOZADENANT | Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;European Union;Canada;Spain;Austria;Germany | ||
| 515 | EUCTR2014-005630-60-IT (EUCTR) | 23/09/2015 | 17/01/2022 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson's DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tozadenant Product Code: SYN115 Other descriptive name: TOZADENANT | BIOTIE THERAPIES INC. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Czech Republic;Canada;Spain;Austria;Germany;Italy | ||
| 516 | EUCTR2014-004865-26-IT (EUCTR) | 21/09/2015 | 29/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | |||
| 517 | NCT02542696 (ClinicalTrials.gov) | August 31, 2015 | 3/9/2015 | Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277 | Sunovion | NULL | Completed | 18 Years | N/A | All | 427 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom |
| 518 | EUCTR2014-004865-26-DE (EUCTR) | 27/08/2015 | 22/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 519 | EUCTR2015-000373-13-DE (EUCTR) | 18/08/2015 | 18/05/2015 | A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s disease | Phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. | Parkinson’s disease levodopa induced dyskinesia (PD-LID) MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE Product Name: Eltoprazine Hydrochloride INN or Proposed INN: ELTOPRAZINE | Amarantus BioScience Holdings, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Germany;Sweden | ||
| 520 | EUCTR2014-004865-26-SE (EUCTR) | 05/08/2015 | 25/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 521 | NCT02337751 (ClinicalTrials.gov) | July 10, 2015 | 9/1/2015 | A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 198 | Phase 3 | Japan |
| 522 | NCT02459886 (ClinicalTrials.gov) | July 1, 2015 | 29/5/2015 | Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's Disease | A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease | Parkinson's Disease;Healthy | Drug: BIIB054;Drug: Placebo | Biogen | NULL | Completed | 40 Years | 80 Years | All | 66 | Phase 1 | United States |
| 523 | NCT02453386 (ClinicalTrials.gov) | July 2015 | 21/5/2015 | Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD) | Idiopathic Parkinson's Disease | Drug: tozadenant;Drug: placebo | Biotie Therapies Inc. | NULL | Terminated | 30 Years | 80 Years | All | 449 | Phase 3 | United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic |
| 524 | EUCTR2014-003738-24-AT (EUCTR) | 26/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | Germany;Spain;Austria;United States | ||
| 525 | EUCTR2014-000657-36-NL (EUCTR) | 22/06/2015 | 03/06/2015 | Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions | Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hydrocortisone cream 10mg/g FNA Fagron Product Name: Hydrocortisone cream Trade Name: Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial' Product Name: Solu-Cortef Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 526 | EUCTR2014-004865-26-ES (EUCTR) | 19/06/2015 | 15/06/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | Greece;Canada;Sweden;European Union;Italy;Australia;Germany;Spain | ||
| 527 | EUCTR2014-003739-20-AT (EUCTR) | 19/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Austria;Germany | ||
| 528 | NCT02469090 (ClinicalTrials.gov) | June 18, 2015 | 9/6/2015 | Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease, Off Episodes | Drug: APL-130277;Drug: Placebo | Sunovion | NULL | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States;Canada;United Kingdom |
| 529 | NCT02230930 (ClinicalTrials.gov) | June 2015 | 29/8/2014 | Treatment of Apomorphine-induced Skin Reactions: a Pilot Study | Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions | Parkinson's Disease;Apomorphine-induced Skin Reactions | Drug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mg | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 530 | EUCTR2014-005422-35-GB (EUCTR) | 28/05/2015 | 02/04/2015 | The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease. | THE ROLE OF BUSPIRONE IN ATTENUATING LEVODOPA-INDUCED DYSKINESIAS IN PATIENTS WITH PARKINSON'S DISEASE: A CLINICAL AND POSITRON EMISSION TOMOGRAPHY STUDY WITH 11C-PHNO. - The role of buspirone in LIDs in patients with Parkinson’s disease. | Levodopa induced dyskinesias within Parkinson's disease. MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Buspirone Hydrochloride Product Name: Buspirone Hydrochloride INN or Proposed INN: Buspirone Hydrochloride | Imperial College London-Imperial College Healthcare NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 531 | JPRN-jRCTs061180028 | 11/05/2015 | 26/02/2019 | Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine | Parkinson's disease;D010300 | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ando Rina | NULL | Complete | 20 years old | None | Both | 50 | Phase 2 | Japan |
| 532 | EUCTR2014-003799-22-AT (EUCTR) | 08/05/2015 | 12/01/2015 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 533 | EUCTR2010-024424-26-SK (EUCTR) | 05/05/2015 | 28/04/2015 | Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's disease | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo on cognitive impairment associated with Parkinson's disease | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Product Name: masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany | ||
| 534 | NCT02439203 (ClinicalTrials.gov) | May 2015 | 30/4/2015 | Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010 | Parkinson's Disease;Levodopa Induced Dyskinesia (LID) | Drug: JM-010;Drug: Placebo | Bukwang Pharmaceutical | Contera Pharma ApS | Completed | 18 Years | N/A | Both | 30 | Phase 2 | South Africa |
| 535 | NCT02448914 (ClinicalTrials.gov) | May 2015 | 12/5/2015 | A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients | A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease | Parkinson's Disease | Drug: TRIGEL;Drug: Duodopa | LobSor Pharmaceuticals AB | TFS Trial Form Support | Completed | 30 Years | N/A | All | 11 | Phase 1 | Sweden |
| 536 | NCT02604914 (ClinicalTrials.gov) | May 2015 | 3/11/2015 | A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects | 1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel | Parkinson's Disease | Drug: ND0612;Drug: LCIG | NeuroDerm Ltd. | Quotient Clinical | Completed | 30 Years | 65 Years | All | 36 | Phase 1 | United Kingdom |
| 537 | NCT02439125 (ClinicalTrials.gov) | May 2015 | 13/4/2015 | A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients | Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease;Dyskinesia | Drug: Eltoprazine HCl;Drug: Placebo | Amarantus BioScience Holdings, Inc. | NULL | Active, not recruiting | 30 Years | 85 Years | Both | 60 | Phase 2 | United States |
| 538 | EUCTR2014-003739-20-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Spain;Austria;Germany | ||
| 539 | EUCTR2014-003738-24-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 540 | EUCTR2014-003799-22-DE (EUCTR) | 22/04/2015 | 04/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 541 | EUCTR2014-003739-20-FR (EUCTR) | 10/04/2015 | 19/06/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Germany | ||
| 542 | NCT02486432 (ClinicalTrials.gov) | April 2015 | 22/6/2015 | A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) | A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach | Parkinson's Disease | Drug: Levodopa/Carbidopa (Sinemet) | NeuroDerm Ltd. | Quotient Clinical | Completed | 40 Years | 65 Years | Both | 6 | Phase 1 | NULL |
| 543 | NCT02390089 (ClinicalTrials.gov) | April 2015 | 19/2/2015 | Cough According to Stimulus Type in PD | Airway Protection Deficits According to Stimulus Type in Parkinson's Disease | Parkinson's Disease | Drug: Capsaicin vapor;Other: fog;Radiation: Videofluoroscopic swallow evaluation;Device: Nebulizer | University of Florida | National Institute on Deafness and Other Communication Disorders (NIDCD) | Completed | 50 Years | 80 Years | All | 158 | Phase 1 | United States |
| 544 | EUCTR2014-003738-24-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 545 | EUCTR2014-003739-20-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia | Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release Capsule Product Code: ADS-5102 INN or Proposed INN: Amantadine hydrochloride (HCl) Other descriptive name: AMANTADINE HYDROCHLORIDE | Adamas Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Austria;Germany | ||
| 546 | EUCTR2014-003799-22-BE (EUCTR) | 16/03/2015 | 16/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 547 | NCT02393027 (ClinicalTrials.gov) | March 2015 | 6/3/2015 | Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999 | Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999 | Idiopathic Parkinson Disease | Drug: [18F] LBT-999 PET | University Hospital, Tours | NULL | Terminated | 45 Years | 75 Years | All | 16 | Early Phase 1 | France |
| 548 | NCT02352363 (ClinicalTrials.gov) | March 2015 | 26/1/2015 | Randomized Safety Study of CVT-301 Compared to an Observational Control Group | A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control | Idiopathic Parkinson's Disease | Drug: CVT-301;Other: Observational cohort | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 408 | Phase 3 | United States;Austria;Belgium;Czechia;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Serbia;Spain;United Kingdom;Czech Republic;Italy |
| 549 | NCT02066571 (ClinicalTrials.gov) | March 2015 | 18/2/2014 | Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease | Parkinson's Disease;Freezing of Gait;Cognitive Ability, General | Drug: Droxidopa;Drug: sugar pill | Henry Ford Health System | NULL | Enrolling by invitation | 30 Years | N/A | Both | 20 | Phase 2 | United States |
| 550 | NCT02373072 (ClinicalTrials.gov) | March 2015 | 20/2/2015 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease | A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson Disease | Drug: PF-06649751;Drug: Trimethobenzamide Hydrochloride;Drug: Placebo | Pfizer | NULL | Completed | N/A | N/A | All | 18 | Phase 1 | United States;Belgium |
| 551 | EUCTR2014-003799-22-CZ (EUCTR) | 26/02/2015 | 26/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 552 | EUCTR2014-003799-22-HU (EUCTR) | 11/02/2015 | 20/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Romania;Germany | ||
| 553 | NCT02337725 (ClinicalTrials.gov) | February 7, 2015 | 9/1/2015 | A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa | Parkinson's Disease | Drug: TVP-1012;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 80 Years | All | 244 | Phase 3 | Japan |
| 554 | NCT02337764 (ClinicalTrials.gov) | February 3, 2015 | 9/1/2015 | A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's Disease | Drug: TVP-1012 1mg | Takeda | NULL | Completed | 30 Years | 79 Years | All | 222 | Phase 3 | Japan |
| 555 | JPRN-JapicCTI-152762 | 03/2/2015 | 06/01/2015 | A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Patients | A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients | Parkinson's disease | Intervention name : TVP-1012 (1 mg/day) with levodopa INN of the intervention : - Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 30 | 79 | BOTH | 222 | Phase 3 | Japan |
| 556 | EUCTR2014-003799-22-ES (EUCTR) | 02/02/2015 | 16/12/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson?s disease | A Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson?s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Phase 3 | Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 557 | NCT02339064 (ClinicalTrials.gov) | February 2015 | 31/3/2014 | Infusion of Apomorphine: Long-term Safety Study | A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy | Idiopathic Parkinson's Disease | Drug: apomorphine infusion | US WorldMeds LLC | NULL | Active, not recruiting | 30 Years | N/A | All | 99 | Phase 3 | United States |
| 558 | NCT02337738 (ClinicalTrials.gov) | January 27, 2015 | 9/1/2015 | A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off | Parkinson's Disease | Drug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: Placebo | Takeda | NULL | Completed | 30 Years | 79 Years | All | 404 | Phase 2/Phase 3 | Japan |
| 559 | EUCTR2014-003799-22-GB (EUCTR) | 15/01/2015 | 21/11/2014 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease | A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 365 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany | ||
| 560 | NCT02406105 (ClinicalTrials.gov) | January 2015 | 22/2/2015 | An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease | An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland | Parkinson Disease | Radiation: Radiosurgical thalamotomy;Drug: CyberKnife | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology | NULL | Recruiting | 18 Years | N/A | Both | 27 | Phase 2 | Poland |
| 561 | NCT02347059 (ClinicalTrials.gov) | January 2015 | 20/1/2015 | L-dopa Versus Dopamine Agonists After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease | A Randomized, Single-blind Trial on the Efficacy and Safety of L-dopa Monotherapy Versus Dopamine Agonists Monotherapy After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease | Parkinson's Disease | Drug: L-dopa;Drug: Dopamine Agonists (pramipexole, ropirinole) | University of Toronto | Michael J. Fox Foundation for Parkinson's Research | Recruiting | N/A | N/A | Both | 40 | Phase 2 | Canada |
| 562 | NCT02258152 (ClinicalTrials.gov) | December 22, 2014 | 3/10/2014 | SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) | SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE) | Parkinson's Disease Dementia (PDD) | Drug: SYN120;Drug: Placebo | Biotie Therapies Inc. | Michael J. Fox Foundation for Parkinson's Research;Massachusetts General Hospital;Acorda Therapeutics | Completed | 50 Years | N/A | All | 82 | Phase 2 | United States |
| 563 | EUCTR2014-004501-32-NL (EUCTR) | 11/12/2014 | 03/12/2014 | Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments | Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation) | Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 564 | NCT02267434 (ClinicalTrials.gov) | December 2014 | 4/9/2014 | Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease | A Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's Disease | Parkinson Disease;Neurodegenerative Diseases | Biological: Low dose AFFITOPE® PD03A + Adjuvant;Biological: High dose AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active component | Affiris AG | PROSENEX AmbulatoriumbetriebsGMBH;Medical University Innsbruck;Forschungszentrum Juelich | Completed | 45 Years | 70 Years | Both | 36 | Phase 1 | Austria |
| 565 | EUCTR2014-001132-10-FR (EUCTR) | 18/11/2014 | 18/06/2015 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | United States;France;Canada;Spain;Germany | |||
| 566 | ChiCTR-DDD-17010794 | 2014-11-08 | 2017-03-05 | The study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | the study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | Parkinson's Disease | Gold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study. Transcranial ultrasound study Ultrasonography through temporal window, alon; | Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital | NULL | Completed | 36 | 84 | Both | Target condition:135;Difficult condition:0 | China | |
| 567 | EUCTR2014-001131-36-ES (EUCTR) | 23/10/2014 | 03/09/2014 | A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 568 | EUCTR2014-001132-10-ES (EUCTR) | 23/10/2014 | 02/09/2014 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias | Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE Product Name: Amantadine HCl Extended Release INN or Proposed INN: Amantadine hydrochloride Other descriptive name: AMANTADINE HYDROCHLORIDE | Osmotica Pharmaceutical Corp. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 569 | EUCTR2014-002295-87-IT (EUCTR) | 13/10/2014 | 29/09/2014 | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. | Parkinson's disease patients who suffer motor fluctuations willparticipate in the study MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 100 mg + 25 mg compresse Product Name: SINEMET 100 mg + 25 mg compresse Product Code: NA | SynAgile Corporation | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 570 | NCT02224664 (ClinicalTrials.gov) | October 2014 | 15/8/2014 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s Disease | A Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor Fluctuations | Parkinson`s Disease | Drug: PF-06649751 | Pfizer | NULL | Completed | 30 Years | 80 Years | All | 50 | Phase 1 | United States;Belgium |
| 571 | JPRN-UMIN000016893 | 2014/09/22 | 01/04/2015 | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. | PD patients | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ehime University HospitalDept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Phase 2 | Japan |
| 572 | NCT02236260 (ClinicalTrials.gov) | September 3, 2014 | 29/8/2014 | Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation | Evaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders. | Parkinson's Disease | Procedure: Electroacupuncture;Drug: Local Anesthesia (lidocaine hydrochloride) | Nantes University Hospital | NULL | Completed | 18 Years | 74 Years | All | 20 | N/A | France |
| 573 | NCT02225548 (ClinicalTrials.gov) | September 2014 | 22/8/2014 | Sagene 2014 - Parkinson's Disease and Erectile Dysfunction | An Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction. | Parkinson's Disease;Erectile Dysfunction | Drug: Selegiline;Drug: Tadalafil | University of South Florida | NULL | Recruiting | 40 Years | 64 Years | Male | 10 | Phase 4 | United States |
| 574 | NCT02230904 (ClinicalTrials.gov) | September 2014 | 29/8/2014 | A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine (Test product PR 2.3.1);Drug: Rotigotine (Reference product PR 2.1.1) | UCB BIOSCIENCES GmbH | Pharmaceutical Health Sciences;Bracket Global | Completed | 18 Years | N/A | All | 57 | Phase 1 | Germany |
| 575 | NCT02228590 (ClinicalTrials.gov) | August 31, 2014 | 26/8/2014 | A Study to Examine APL-130277 in Patients With Parkinson's Disease | A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: APL-130277 | Sunovion | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | United States |
| 576 | NCT02153645 (ClinicalTrials.gov) | August 18, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID. | A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesias (LID) | Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tablets | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 87 | Phase 3 | United States;Canada;France;Germany;Spain |
| 577 | NCT02438215 (ClinicalTrials.gov) | August 2014 | 7/8/2014 | Study of IRX4204 for Treatment of Early Parkinson's Disease | An Open-Label, Single Site Study Using [123I]ß-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease Subjects | Parkinson's Disease | Drug: IRX4204 | Io Therapeutics | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States |
| 578 | NCT02216188 (ClinicalTrials.gov) | August 2014 | 12/8/2014 | Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity | Phase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008 | Parkinson's Disease | Biological: AFFITOPE® PD01A;Other: Control | Affiris AG | NULL | Completed | 40 Years | 68 Years | Both | 28 | Phase 1 | Austria |
| 579 | NCT02763137 (ClinicalTrials.gov) | July 30, 2014 | 26/4/2016 | Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients | A Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor Fluctuations | Parkinson Disease | Drug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CD | IRCCS San Raffaele Roma | SynAgile Corporation | Completed | 35 Years | 75 Years | All | 18 | Phase 2 | Italy |
| 580 | NCT02153632 (ClinicalTrials.gov) | July 30, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID | A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesia (LID) | Drug: amantadine HCl ER;Drug: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 135 | Phase 3 | United States;Canada;France;Germany;Spain |
| 581 | JPRN-UMIN000014709 | 2014/07/01 | 01/08/2014 | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders | Patients of Parkinson's disease and related disorders | The dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging. | Tokyo Metropolitan Institute of Gerontology | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 582 | NCT02472210 (ClinicalTrials.gov) | July 2014 | 11/6/2015 | The Use of Botox in Advanced Parkinson's Patients Experiencing Pain | A Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot Study | Parkinson's Disease | Drug: Botulinum Toxin | University Health Network, Toronto | NULL | Active, not recruiting | 18 Years | N/A | Both | 14 | Phase 4 | NULL |
| 583 | ChiCTR-TRC-14004707 | 2014-06-09 | 2014-05-27 | The effect of different patterns of rehabilitation training in idiopathic Parkinson's disease | The effect of different patterns of rehabilitation training in idiopathic Parkinson's disease | Parkinson's disease | Tai Chi group:Tai Chi;Balance function training group:Balance function training; | Shanghai Tongji Hospital | NULL | Completed | 20 | 90 | Both | Tai Chi group:30;Balance function training group:30; | China | |
| 584 | EUCTR2013-000980-10-DK (EUCTR) | 06/06/2014 | 09/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Austria;Denmark;Netherlands;Germany | ||
| 585 | EUCTR2012-005539-10-DE (EUCTR) | 29/04/2014 | 18/12/2013 | Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions. | Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation | Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury. MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A Trade Name: Xeomin INN or Proposed INN: NT 101 Other descriptive name: BOTULINUM TOXIN TYPE A | Merz Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Poland;Germany | ||
| 586 | EUCTR2013-002254-70-PL (EUCTR) | 28/04/2014 | 03/02/2014 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany | ||
| 587 | NCT02741947 (ClinicalTrials.gov) | April 2014 | 31/3/2016 | Levodopa Benserazide Generic Formulation Versus the Originator | Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®) | Parkinson Disease | Drug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva Italia | IRCCS San Raffaele | Agenzia Italiana del Farmaco | Completed | 30 Years | 75 Years | Both | 44 | Phase 4 | Italy |
| 588 | NCT01738178 (ClinicalTrials.gov) | April 2014 | 28/11/2012 | Caffeine as a Therapy for Parkinson's Disease | Caffeine as a Therapeutic Agent in Parkinson's Disease | Parkinson's Disease | Drug: Caffeine;Drug: Placebo | McGill University Health Center | Pontifícia Universidade Católica do Paraná;University of Calgary;University of Newfoundland and Eastern Health;University Health Network, Toronto;UBC Hospital;Movement Disorder Clinic - Deer Lodge Centre;The Ottawa Hospital | Completed | 45 Years | 75 Years | All | 119 | Phase 3 | Brazil;Canada |
| 589 | NCT02091739 (ClinicalTrials.gov) | April 2014 | 18/3/2014 | Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Chronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain Injury | Drug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: Placebo | Merz Pharmaceuticals GmbH | NULL | Completed | 18 Years | 80 Years | All | 184 | Phase 3 | Germany;Poland;United States |
| 590 | NCT02082249 (ClinicalTrials.gov) | March 10, 2014 | 14/2/2014 | An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications | An Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications | Advanced Parkinson's Disease | Drug: ABT-SLV187 | AbbVie | NULL | Completed | 30 Years | 99 Years | All | 30 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 591 | EUCTR2013-002254-70-CZ (EUCTR) | 05/03/2014 | 02/12/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 592 | NCT02006121 (ClinicalTrials.gov) | March 3, 2014 | 22/11/2013 | Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease | Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment | Parkinson's Disease | Drug: Apomorphine hydrochloride;Drug: Placebo | Britannia Pharmaceuticals Ltd. | NULL | Completed | 30 Years | N/A | All | 107 | Phase 3 | Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom |
| 593 | EUCTR2013-000980-10-FR (EUCTR) | 03/03/2014 | 22/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 594 | NCT02006290 (ClinicalTrials.gov) | March 2014 | 5/12/2013 | Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease | A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: PF-06412562;Drug: Placebo | Pfizer | NULL | Completed | 30 Years | 75 Years | Both | 19 | Phase 1 | United States |
| 595 | NCT02111330 (ClinicalTrials.gov) | March 2014 | 20/3/2014 | Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy Volunteers | Parkinson Disease | Drug: PBF-509;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Palo Biofarma, S.L | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Spain |
| 596 | EUCTR2013-002254-70-DE (EUCTR) | 28/02/2014 | 19/11/2013 | Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy. | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany | ||
| 597 | EUCTR2013-002254-70-IT (EUCTR) | 21/02/2014 | 27/11/2013 | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease | Moderate to severe Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE Product Name: KW-6002 (istradefylline) Product Code: KW-6002 INN or Proposed INN: Istradefylline Other descriptive name: ISTRADEFYLLINE | Kyowa Hakko Kirin Pharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 3 | United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy | ||
| 598 | EUCTR2013-000980-10-ES (EUCTR) | 12/02/2014 | 12/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 599 | EUCTR2013-000980-10-NL (EUCTR) | 06/02/2014 | 27/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Germany;Netherlands | ||
| 600 | NCT02064166 (ClinicalTrials.gov) | February 2014 | 13/2/2014 | Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin. | A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy | Parkinson Disease;Multiple System Atrophy | Drug: Intranasal Insulin | Peter Novak | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | United States |
| 601 | NCT02103894 (ClinicalTrials.gov) | February 2014 | 12/2/2014 | Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects | Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Clinically Diagnosed Tauopathies in Comparison to Healthy Subjects | Alzheimer's Disease (AD);Parkinson's Disease (PD);Chronic Traumatic Encephalopathy (CTE);Progressive Supranuclear Palsy (PSP);Frontal Temporal Dementia (FTD);Pick's Disease;Tauopathies | Drug: [18F]T807 ([18F]MNI-777) | Molecular NeuroImaging | Institute for Neurodegenerative Disorders | Completed | 18 Years | 85 Years | Both | 16 | Phase 1 | United States |
| 602 | EUCTR2013-002545-10-SE (EUCTR) | 08/01/2014 | 11/11/2013 | An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. | An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309 | Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: OSU6162 similar to (-)-OSU 6162 | A. Carlsson Research AB | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Sweden | ||
| 603 | NCT02384512 (ClinicalTrials.gov) | January 2014 | 4/3/2015 | Azilect® In Wearing-Off (AIWO) | Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32) | Parkinson's Disease | Drug: Azilect® | Teva Pharma GmbH | Anfomed GmbH | Completed | 18 Years | N/A | Both | 261 | N/A | Germany |
| 604 | NCT01968460 (ClinicalTrials.gov) | December 2013 | 15/10/2013 | Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease | Parkinson's Disease | Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), | Pharma Two B Ltd. | NULL | Completed | 35 Years | 75 Years | All | 149 | Phase 2/Phase 3 | United States;Israel |
| 605 | NCT01883505 (ClinicalTrials.gov) | December 2013 | 9/6/2013 | A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 | A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612 | Parkinson's Disease | Drug: Levodopa and carbidopa;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | Israel |
| 606 | NCT04044547 (ClinicalTrials.gov) | November 22, 2013 | 30/7/2019 | A Study of LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson Disease | Drug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 60 | Phase 1 | NULL |
| 607 | EUCTR2012-002840-26-RO (EUCTR) | 12/11/2013 | 17/07/2014 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 608 | NCT01856738 (ClinicalTrials.gov) | November 2013 | 14/5/2013 | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial. | Parkinson's Disease | Drug: Rivastigmine;Drug: Placebo (for rivastigmine) | VU University Medical Center | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and Development | Terminated | 40 Years | N/A | All | 91 | Phase 4 | Netherlands |
| 609 | NCT01927055 (ClinicalTrials.gov) | November 2013 | 16/8/2013 | A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy | A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy | Symptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase Deficiency | Drug: Droxidopa;Drug: Placebo | Chelsea Therapeutics | NULL | Terminated | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 610 | EUCTR2011-004438-32-DE (EUCTR) | 23/10/2013 | 13/08/2013 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Australia;Germany;United Kingdom;Sweden | |||
| 611 | EUCTR2013-000980-10-AT (EUCTR) | 18/10/2013 | 31/07/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 612 | NCT01968031 (ClinicalTrials.gov) | October 2013 | 18/10/2013 | A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease | A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Istradefylline 40 mg;Drug: Istradefylline 20 mg;Drug: Placebo | Kyowa Hakko Kirin Pharma, Inc. | Kyowa Kirin Co., Ltd. | Completed | 30 Years | N/A | All | 613 | Phase 3 | United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic |
| 613 | NCT01973543 (ClinicalTrials.gov) | October 2013 | 25/10/2013 | Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's Disease | An Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to Levodopa | Parkinson's Disease | Biological: VY-AADC01 | Neurocrine Biosciences | University of California, San Francisco;Veristat, Inc.;Feinstein Institute for Medical Research;Oregon Health and Science University;Voyager Therapeutics | Completed | 40 Years | 70 Years | All | 15 | Phase 1 | United States |
| 614 | NCT01960842 (ClinicalTrials.gov) | October 2013 | 9/10/2013 | A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 31 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 615 | NCT02055274 (ClinicalTrials.gov) | October 2013 | 31/1/2014 | Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease | A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections | Parkinson's Disease | Drug: LY03003;Drug: Neupro | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | N/A | Both | 39 | Phase 1 | United States |
| 616 | EUCTR2013-001881-40-GB (EUCTR) | 16/09/2013 | 05/08/2013 | Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD) | An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease | Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF | North Bristol NHS Trust (NBT) | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 617 | NCT01955616 (ClinicalTrials.gov) | September 2013 | 25/9/2013 | A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current Therapy | Parkinson's Disease | Drug: RM-131;Drug: Placebo | Motus Therapeutics, Inc. | Michael J. Fox Foundation for Parkinson's Research | Terminated | 18 Years | 80 Years | Both | 18 | Phase 2 | United States |
| 618 | NCT01929317 (ClinicalTrials.gov) | August 28, 2013 | 22/8/2013 | A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients. | A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease. | Parkinson Disease | Drug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tablet | GlaxoSmithKline | NULL | Terminated | 20 Years | N/A | All | 81 | Phase 3 | Japan |
| 619 | EUCTR2013-001722-25-NL (EUCTR) | 27/08/2013 | 12/08/2013 | Rivastigmine as an early treatment for visual hallucinations in Parkinson’s disease (CHEVAL) | Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson’s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVAL | Parkinson's disease MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rivastigmine CF | VU University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 168 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 620 | EUCTR2011-004438-32-SE (EUCTR) | 26/08/2013 | 01/07/2013 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 16.0;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Australia;Germany;United Kingdom;Sweden | |||
| 621 | NCT01767129 (ClinicalTrials.gov) | July 2013 | 9/1/2013 | Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients | A Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients. | Dyskinesia;Parkinson's Disease | Drug: AVP-923-45;Drug: Placebo | Avanir Pharmaceuticals | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 14 | Phase 2 | United States;Canada |
| 622 | EUCTR2012-001245-40-IT (EUCTR) | 05/06/2013 | 17/05/2013 | CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) | PARKINSON'S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Madopar 200+50 mg Trade Name: LEVODOPA / BENSERAZIDE 200 + 50 MG | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 623 | NCT01879748 (ClinicalTrials.gov) | June 2013 | 13/6/2013 | A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline | A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 20 Years | 50 Years | Both | 64 | Phase 1 | United States |
| 624 | NCT01765257 (ClinicalTrials.gov) | June 2013 | 8/1/2013 | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study. | Drug-naïve Patients With Parkinson's Disease;Apathy | Drug: AZILECT®;Drug: Placebo | University Hospital, Clermont-Ferrand | H. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild Paris | Not yet recruiting | 30 Years | 70 Years | Both | 50 | Phase 4 | France |
| 625 | NCT01850381 (ClinicalTrials.gov) | June 2013 | 7/5/2013 | Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease | GM 608 in A Phase IIA Pilot Double-blinded, Randomized, Placebo Controlled Trial in Mild to Moderate Parkinson Disease | Parkinson's Disease | Drug: GM608;Drug: Placebo Comparator | Genervon Biopharmaceuticals, LLC | Columbia University | Completed | 30 Years | N/A | All | 6 | Phase 2 | United States |
| 626 | NCT01860794 (ClinicalTrials.gov) | May 2013 | 14/5/2013 | Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease | Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease | Idiopathic Parkinson Disease;Primary Parkinsonism | Drug: Mesencephalic Neuronal Precursor Cells | Bundang CHA Hospital | NULL | Recruiting | 18 Years | 70 Years | Female | 15 | Phase 1/Phase 2 | Korea, Republic of |
| 627 | EUCTR2012-002840-26-BG (EUCTR) | 26/04/2013 | 06/02/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 628 | EUCTR2011-002828-41-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease. | A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. | Advanced Parkinson's disease. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REQUIP-MODUTAB, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: REQUIP-MODUTAB, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 629 | JPRN-UMIN000010371 | 2013/04/08 | 01/04/2013 | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. - Study of zonisamide to tremor in patients with early Parkinson's disease. | Parkinson's disease | Start 25mg of Zonisamide and carry out observation 24weeks. Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks. | Department of Neurology, University of Yamanashi | NULL | Pending | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 630 | EUCTR2012-002608-42-GB (EUCTR) | 07/04/2013 | 01/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | ||
| 631 | NCT01829867 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031. | A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular Infusion | Parkinson's Disease | Drug: sNN0031 | Newron Sweden AB | NULL | Terminated | 55 Years | 75 Years | Both | 5 | Phase 1 | Sweden |
| 632 | EUCTR2011-002828-41-SK (EUCTR) | 27/03/2013 | 04/03/2013 | A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease. | A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. | Advanced Parkinson's disease. MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Requip Modutab, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Requip Modutab, 8mg Product Name: ropinirole PR Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 633 | EUCTR2012-002840-26-SI (EUCTR) | 26/03/2013 | 18/03/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 634 | NCT04627155 (ClinicalTrials.gov) | March 15, 2013 | 5/11/2020 | A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003 | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular Injection | Parkinson Disease | Drug: LY03003 | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | NULL |
| 635 | JPRN-UMIN000009958 | 2013/03/08 | 01/03/2013 | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction - Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Parkinson's disease | Donepezil hydrochloride added to standard therapy Placebo added to standard therapy | National Hospital Organization, Sendai-Nishitaga Hospital | NULL | Complete: follow-up complete | 55years-old | 75years-old | Male and Female | 200 | Not applicable | Japan |
| 636 | EUCTR2012-002840-26-AT (EUCTR) | 05/03/2013 | 06/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 637 | JPRN-UMIN000046104 | 2013/03/01 | 21/11/2021 | Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease | Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease - RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya | Parkinson's disease | This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen. During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences. | Nagoya City University | NULL | Complete: follow-up complete | 60years-old | 75years-old | Male and Female | 12 | Not applicable | Japan |
| 638 | NCT01789047 (ClinicalTrials.gov) | March 2013 | 7/2/2013 | Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease | Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease | Idiopathic Parkinson's Disease;Drug Induced Dyskinesia | Drug: Topiramate;Drug: Placebo;Drug: Amantadine | Rush University Medical Center | Michael J. Fox Foundation for Parkinson's Research | Terminated | 30 Years | 90 Years | All | 42 | Phase 2 | United States |
| 639 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease | An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| 640 | EUCTR2012-002840-26-IT (EUCTR) | 18/02/2013 | 11/01/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro INN or Proposed INN: ROTIGOTINE | UCB BIOSCIENCES GMBH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy | ||
| 641 | EUCTR2012-002840-26-HU (EUCTR) | 11/02/2013 | 13/12/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 642 | NCT01782222 (ClinicalTrials.gov) | February 2013 | 30/1/2013 | Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy | A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood | Idiopathic Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 122 | Phase 4 | United States;Austria;Hungary;Poland;Slovakia;Slovenia;Spain |
| 643 | EUCTR2012-002840-26-ES (EUCTR) | 23/01/2013 | 29/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 644 | EUCTR2012-002608-42-HU (EUCTR) | 10/01/2013 | 12/11/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 645 | EUCTR2012-002608-42-DE (EUCTR) | 10/01/2013 | 26/09/2012 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Hungary;Slovakia;Poland;Germany;United Kingdom | |||
| 646 | EUCTR2012-002840-26-SK (EUCTR) | 07/01/2013 | 09/03/2016 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 647 | NCT01803945 (ClinicalTrials.gov) | January 2013 | 26/2/2013 | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AVE8112;Drug: Placebo | Michael J. Fox Foundation for Parkinson's Research | Sanofi | Terminated | 35 Years | 70 Years | Both | 32 | Phase 1 | United States |
| 648 | NCT01500707 (ClinicalTrials.gov) | January 2013 | 22/12/2011 | Single Dose Study to Assess the Pharmacokinetics of SCH 900800 in Subjects With Parkinson's Disease Being Treated With Levodopa (L-DOPA) (P08235) | A Single Dose Study to Assess the Pharmacokinetics of SCH 900800 Administered as Oral Tablets in L-DOPA-treated Subjects With Parkinson's Disease | Parkinson's Disease | Drug: SCH 900800 | Merck Sharp & Dohme Corp. | NULL | Withdrawn | 30 Years | 85 Years | Both | 0 | Phase 1 | NULL |
| 649 | EUCTR2012-002608-42-SK (EUCTR) | 17/12/2012 | 09/03/2016 | A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Parkinson’s disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 478 | France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of | |||
| 650 | NCT01725802 (ClinicalTrials.gov) | December 2012 | 4/11/2012 | A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | Parkinson's Disease | Drug: levodopa and carbidopa solution for SC administration;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 8 | Phase 1/Phase 2 | Israel |
| 651 | NCT02112812 (ClinicalTrials.gov) | December 2012 | 10/4/2014 | Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's Disease | A Study on Clinical Response Following Eradication Therapy of Helicobacter Pylori Infection in Parkinson's Disease | Response to Levodopa;Motor Outcomes;Quality of Life Outcomes | Drug: Eradication therapy for H.pylori infection;Drug: Eradication of Helcobacter Pylori;Drug: Eradication therapy for Helicobacter pylori | National University of Malaysia | NULL | Completed | 17 Years | N/A | Both | 82 | N/A | Malaysia |
| 652 | NCT01683253 (ClinicalTrials.gov) | November 2012 | 7/9/2012 | Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa | The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy | Impulse Control Disorder | Drug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic Agonists | Sandoz | NULL | Completed | 30 Years | 80 Years | All | 150 | Phase 4 | Korea, Republic of |
| 653 | NCT01744496 (ClinicalTrials.gov) | November 2012 | 5/12/2012 | Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain | Advanced Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 68 | Phase 4 | United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of |
| 654 | NCT01723228 (ClinicalTrials.gov) | November 2012 | 5/11/2012 | Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 45 Years | 80 Years | All | 170 | Phase 4 | United States |
| 655 | NCT03652363 (ClinicalTrials.gov) | October 25, 2012 | 21/8/2018 | GDNF in ideopathicParkinsons Disease | A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s Disease | Idiopathic Parkinson Disease | Drug: glial cell line-derived neurotrophic factor | North Bristol NHS Trust | NULL | Completed | 35 Years | 75 Years | All | 42 | Phase 2 | NULL |
| 656 | NCT01723904 (ClinicalTrials.gov) | October 2012 | 6/11/2012 | A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease | An Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3B | Advanced Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 90 | Phase 3 | Australia;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 657 | NCT01691924 (ClinicalTrials.gov) | October 2012 | 13/9/2012 | Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers | Randomized, Double Blind, Placebo Controlled First In-human Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy Volunteers | Parkinson Disease | Drug: PBF-509;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Palo Biofarma, S.L | Completed | 18 Years | 45 Years | Male | 56 | Phase 1 | Spain |
| 658 | NCT01560754 (ClinicalTrials.gov) | October 2012 | 9/3/2012 | Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease | A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess the Disease-modifying Potential of Transdermal Nicotine in Early Parkinson's Disease in Germany and the USA | Parkinson's Disease | Drug: nicotine transdermal patch | James BOYD MD | Michael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, Germany | Active, not recruiting | 30 Years | N/A | Both | 160 | Phase 2 | United States;Germany |
| 659 | NCT01603069 (ClinicalTrials.gov) | October 2012 | 14/5/2012 | A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | A Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: Placebo | AstraZeneca | NULL | Completed | 30 Years | 80 Years | Both | 51 | Phase 2 | United States |
| 660 | EUCTR2011-003866-34-GB (EUCTR) | 24/09/2012 | 01/05/2012 | Assessing the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD) | A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease | Parkinson's disease MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Glial Cell Line-Derived Neurotrophic Factor (GDNF) INN or Proposed INN: Liatermin Other descriptive name: r-metHuGDNF | North Bristol NHS Trust (NBT) | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 661 | EUCTR2011-004378-27-AT (EUCTR) | 04/09/2012 | 20/07/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 662 | NCT01711866 (ClinicalTrials.gov) | September 2012 | 18/10/2012 | A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease | An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4 | Advanced Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB BIOSCIENCES GmbH | Otsuka Pharmaceutical Co., Ltd. | Completed | 30 Years | 80 Years | All | 87 | Phase 4 | United States;Korea, Republic of;Malaysia;Singapore;Taiwan |
| 663 | NCT01684475 (ClinicalTrials.gov) | September 2012 | 11/9/2012 | A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE | A STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASE | Parkinson's Disease | Drug: CJH1 (CLR4001) | Alexandra Marine and General Hospital | NULL | Recruiting | 40 Years | 85 Years | Both | 21 | Phase 1/Phase 2 | Canada |
| 664 | EUCTR2011-004803-19-FI (EUCTR) | 16/08/2012 | 16/05/2012 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 665 | NCT00947037 (ClinicalTrials.gov) | August 2012 | 24/7/2009 | Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects | Parkinson's Disease | Drug: AP-CD/LD | Intec Pharma Ltd. | NULL | Withdrawn | 30 Years | 95 Years | Both | 0 | Phase 2 | Israel |
| 666 | NCT02764892 (ClinicalTrials.gov) | August 2012 | 25/9/2015 | A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease | An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers | Parkinson's Disease | Drug: V81444 | Vernalis (R&D) Ltd | NULL | Completed | 25 Years | 55 Years | Male | 6 | Phase 1 | NULL |
| 667 | JPRN-UMIN000008477 | 2012/07/19 | 19/07/2012 | Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. | Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. - Clinical study of selegiline to flexion of spine in Parkinson's disease. | Parkinson disease | Selegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points. | Department of Neurology, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 668 | NCT01646268 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine;Drug: Placebo Patch | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 249 | Phase 3 | China |
| 669 | NCT01602549 (ClinicalTrials.gov) | July 2012 | 17/5/2012 | A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying | Gastroparesis | Drug: GSK962040 (25 mg tablet);Drug: Placebo | GlaxoSmithKline | NULL | Completed | 40 Years | 80 Years | All | 58 | Phase 2 | Australia;Germany;Sweden;United Kingdom |
| 670 | NCT01491022 (ClinicalTrials.gov) | July 2012 | 8/12/2011 | A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease | A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease | Parkinson's Disease | Drug: Ampyra first, then Placebo;Drug: placebo first, then Ampyra | University of Miami | Acorda Therapeutics | Completed | 45 Years | 80 Years | All | 22 | Phase 1/Phase 2 | United States |
| 671 | NCT01646255 (ClinicalTrials.gov) | July 2012 | 18/7/2012 | Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On Levodopa | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo Patch;Drug: L-dopa | UCB Pharma | UCB Trading (Shanghai) Co. Ltd. | Completed | 30 Years | N/A | All | 346 | Phase 3 | China |
| 672 | EUCTR2011-003053-25-GB (EUCTR) | 18/06/2012 | 01/05/2012 | The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen. | A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen. - ReSPonD Study - Rivastigmine to Stabilise gait in Parkinson’s Disease | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Exelon ® Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine Trade Name: Exelon Product Name: ENA713 Product Code: N/A INN or Proposed INN: Rivastigmine | Research and Enterprise Department | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 673 | EUCTR2011-002074-23-AT (EUCTR) | 05/06/2012 | 07/05/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 674 | JPRN-UMIN000008057 | 2012/06/01 | 06/06/2012 | Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease | Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease - Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease | Parkinson's Disease | Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively. | St. Mariannna University School of Medicine | NULL | Complete: follow-up complete | 35years-old | 80years-old | Male and Female | 25 | Not applicable | Japan |
| 675 | NCT01993680 (ClinicalTrials.gov) | June 2012 | 27/4/2012 | Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -Treatment | A Monocentric Randomized, Controlled, Double Blind, Crossover Phase II Trial to Show Non-inferiority of the Effect of Pyridostigmine Bromide vs. Fludrocortisone on Symptoms of Autonomic Dysregulation in Parkinson's Disease | Autonomic Disturbances in Parkinson's Disease | Drug: Pyridostigmine bromide;Drug: fludrocortisone | Christian Baumann | NULL | Completed | 50 Years | 80 Years | All | 18 | Phase 2 | Switzerland |
| 676 | EUCTR2011-004378-27-DE (EUCTR) | 15/05/2012 | 24/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 677 | EUCTR2011-004378-27-SK (EUCTR) | 02/05/2012 | 12/04/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 678 | JPRN-UMIN000007896 | 2012/05/01 | 07/05/2012 | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Parkinson's disease and other parkinsonian syndromes | The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. | Kansai Medical University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan |
| 679 | EUCTR2011-004438-32-GB (EUCTR) | 25/04/2012 | 18/04/2012 | The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptying | A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC | Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism. MedDRA version: 20.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 Product Name: GSK962040 Product Code: GSK962040 INN or Proposed INN: GSK962040 Other descriptive name: GSK962040 | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;United Kingdom;Sweden | ||
| 680 | EUCTR2011-001092-39-IT (EUCTR) | 19/04/2012 | 20/06/2012 | efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias | A multi-centre, randomized, double-blind, placebo-controlled, parallelgroup, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesias | L-dopa induced dyskinesias in Parkinson's patients MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AQW051 Other descriptive name: Not established Product Name: NA Product Code: AQW051 Other descriptive name: Not established | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 72 | United States;Germany;Italy | |||
| 681 | NCT01494532 (ClinicalTrials.gov) | April 2, 2012 | 1/12/2011 | A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease | A Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole/L-dopa;Drug: placebo/L-dopa | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 352 | Phase 4 | United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 682 | NCT01486628 (ClinicalTrials.gov) | April 2012 | 4/12/2011 | Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 18 Years | 40 Years | Male | 36 | Phase 1 | Israel |
| 683 | NCT01550484 (ClinicalTrials.gov) | April 2012 | 6/3/2012 | A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders | An Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain Diagnosis | Parkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's Disease | Drug: 18F-AV-133 | Avid Radiopharmaceuticals | NULL | Completed | 40 Years | N/A | All | 170 | Phase 2/Phase 3 | United States;Australia |
| 684 | NCT01523301 (ClinicalTrials.gov) | April 2012 | 27/1/2012 | Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Korea Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 380 | Phase 4 | Korea, Republic of |
| 685 | NCT01491529 (ClinicalTrials.gov) | April 2012 | 12/12/2011 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | All | 154 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 686 | NCT01527695 (ClinicalTrials.gov) | April 2012 | 22/12/2011 | PET Study in Parkinson's Disease Patients | A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mg | AstraZeneca | NULL | Completed | 45 Years | 75 Years | Both | 24 | Phase 2 | Sweden |
| 687 | NCT01331122 (ClinicalTrials.gov) | April 2012 | 13/10/2010 | Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease | Gait Disorders, Neurologic | Drug: droxidopa | Chelsea Therapeutics | NULL | Withdrawn | 30 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States;Canada |
| 688 | EUCTR2011-002074-23-ES (EUCTR) | 30/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 689 | EUCTR2011-004378-27-HU (EUCTR) | 28/03/2012 | 15/02/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: mavoglurant | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;France;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 690 | EUCTR2011-002074-23-SK (EUCTR) | 28/03/2012 | 30/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 691 | EUCTR2011-004378-27-IT (EUCTR) | 27/03/2012 | 02/03/2012 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: mavoglurant Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 65 | United States;Hungary;Canada;Spain;Austria;Germany;Italy | |||
| 692 | EUCTR2011-002074-23-HU (EUCTR) | 21/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 693 | EUCTR2011-002074-23-DE (EUCTR) | 20/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 694 | EUCTR2011-002074-23-IT (EUCTR) | 15/03/2012 | 02/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: NA Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 695 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 696 | NCT01538329 (ClinicalTrials.gov) | March 4, 2012 | 20/2/2012 | Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease | Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study) | Parkinson Disease | Drug: Amantadine;Drug: placebo | University Hospital, Toulouse | NULL | Completed | 35 Years | N/A | All | 210 | Phase 2 | France |
| 697 | NCT01565395 (ClinicalTrials.gov) | March 2012 | 26/3/2012 | Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) | Parkinson Disease;Amyotrophic Lateral Sclerosis | Drug: Incobotulinum Toxin A;Drug: placebo | Beth Israel Deaconess Medical Center | Merz Pharmaceuticals | Withdrawn | 20 Years | 80 Years | All | 0 | Phase 2 | United States |
| 698 | NCT01491932 (ClinicalTrials.gov) | March 2012 | 1/12/2011 | Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 129 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 699 | NCT01653132 (ClinicalTrials.gov) | March 2012 | 25/7/2012 | Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism | Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism | Sialorrhea | Drug: Incobotulinum Toxin A;Drug: Placebo | Beth Israel Deaconess Medical Center | NULL | Completed | 18 Years | 90 Years | All | 10 | Phase 2 | United States |
| 700 | NCT03061513 (ClinicalTrials.gov) | February 28, 2012 | 13/2/2017 | Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers | Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers | Parkinson Disease | Drug: Ubiquinol;Dietary Supplement: Placebo | Weill Medical College of Cornell University | NULL | Completed | 40 Years | 75 Years | All | 11 | Phase 2 | NULL |
| 701 | EUCTR2011-004803-19-SE (EUCTR) | 22/02/2012 | 16/12/2011 | PET study in PD patients | A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease | Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AZD3241 Extended release tablets 25 mg Product Code: AZD3241 Product Name: AZD3241 Extended release tablets 100 mg Product Code: AZD3241 Product Name: [11C]PBR28 Product Code: [11C]PBR28 Product Name: [18F]FE-PE2I Product Code: [18F]FE-PE2I | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 702 | EUCTR2011-005054-59-RO (EUCTR) | 21/02/2012 | 13/06/2013 | SYN115 in Parkinson’s disease | A double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none) | Parkinson’s disease MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SYN115 Tablets, 60 mg Product Code: SYN115 INN or Proposed INN: tozadenant Other descriptive name: tozadenant | Biotie Therapies Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | United States;Canada;Argentina;Ukraine;Romania;Chile | |||
| 703 | NCT01568099 (ClinicalTrials.gov) | February 2012 | 16/3/2012 | Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's Disease | A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's Disease | Parkinson's Disease | Biological: AFFITOPE® PD01A;Other: Control | Affiris AG | NULL | Completed | 40 Years | 65 Years | Both | 32 | Phase 1 | Austria |
| 704 | EUCTR2011-005201-75-FR (EUCTR) | 12/01/2012 | 24/01/2012 | N/A | N/A | MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: mantadix Product Name: amantadine | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | France | |||
| 705 | NCT01536015 (ClinicalTrials.gov) | January 2012 | 15/2/2012 | Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction | Advanced Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Pharma | NULL | Terminated | 30 Years | N/A | All | 25 | Phase 3 | United States |
| 706 | NCT01515410 (ClinicalTrials.gov) | January 2012 | 11/1/2012 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations | Parkinson's Disease;Motor Fluctuations | Drug: DM-1992;Drug: Sinemet IR | Depomed | NULL | Completed | 30 Years | N/A | All | 34 | Phase 2 | United States |
| 707 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 708 | EUCTR2009-017412-32-IT (EUCTR) | 13/12/2011 | 27/04/2010 | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND | Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10013363 | Trade Name: BOTOX INN or Proposed INN: Botulinum toxin Trade Name: NEUROBLOC INN or Proposed INN: Botulinum toxin | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 709 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 710 | NCT01521117 (ClinicalTrials.gov) | December 2011 | 12/1/2012 | The Effect of Donepezil on Gait and Balance in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's Disease | Parkinson's Disease | Drug: Donepezil | Oregon Health and Science University | NULL | Recruiting | N/A | N/A | Both | 12 | Phase 4 | United States |
| 711 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODO | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 712 | EUCTR2011-002901-31-GB (EUCTR) | 25/11/2011 | 21/09/2011 | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: Oxycodone hydrochloride INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 713 | EUCTR2009-015162-57-NL (EUCTR) | 21/11/2011 | 11/05/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme corp. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 714 | EUCTR2011-002073-30-IT (EUCTR) | 14/11/2011 | 06/03/2012 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease | L-dopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10043118;Term: Tardive dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA Product Name: AFQ056 Product Code: AFQ056 INN or Proposed INN: NA Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 63 | United States;European Union;Canada;Spain;Germany;Switzerland;Italy | |||
| 715 | EUCTR2009-015162-57-PT (EUCTR) | 04/11/2011 | 12/08/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 716 | NCT01457807 (ClinicalTrials.gov) | November 2011 | 10/10/2011 | To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers | A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female Volunteers | Parkinson's Disease | Drug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 | AstraZeneca | NULL | Completed | 30 Years | 65 Years | Both | 24 | Phase 1 | United Kingdom |
| 717 | NCT01385592 (ClinicalTrials.gov) | November 2011 | 28/6/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | United States;Canada;France;Germany;Hungary;Italy;Spain |
| 718 | EUCTR2009-015162-57-PL (EUCTR) | 25/10/2011 | 30/08/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 719 | EUCTR2011-000056-42-GB (EUCTR) | 07/10/2011 | 11/08/2011 | Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's disease | A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease | Advanced Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Celltech, UK - Registered Branch of UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 720 | JPRN-UMIN000006521 | 2011/10/01 | 11/10/2011 | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole | Parkinson's disease | Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks. | Department of Neurology, Juntendo University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 721 | NCT02427646 (ClinicalTrials.gov) | October 2011 | 22/4/2015 | Kinematic-guided BoNT-A Treatment for ET and PD Tremor | Use of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson Disease | Tremor | Drug: BoNT-A | Western University, Canada | NULL | Active, not recruiting | 18 Years | 80 Years | All | 54 | Phase 2 | NULL |
| 722 | NCT01446614 (ClinicalTrials.gov) | October 2011 | 4/10/2011 | Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease | Phase?/?Trial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease. | Parkinson's Disease | Biological: bone marrow derived mesenchymal stem cells | Guangzhou General Hospital of Guangzhou Military Command | NULL | Recruiting | 30 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | China |
| 723 | NCT01479127 (ClinicalTrials.gov) | October 2011 | 26/9/2011 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: ABT-SLV187;Drug: Oral Levodopa/Carbidopa;Device: Infusion Pump: CADD-Legacy® 1400 Pump;Device: NJ-Tube: Silicon ED Tube;Device: Adaptor: Hakko Adaptor | AbbVie (prior sponsor, Abbott) | Abbott Japan Co.,Ltd | Completed | 30 Years | 99 Years | All | 8 | Phase 2 | Japan |
| 724 | EUCTR2010-018534-44-CZ (EUCTR) | 23/09/2011 | 04/07/2011 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 725 | EUCTR2009-015162-57-IT (EUCTR) | 22/09/2011 | 27/04/2011 | A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND | A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND | Parkinson`s disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH420814 INN or Proposed INN: Preladenant Trade Name: Azilect INN or Proposed INN: Rasagiline | Schering-Plough Research Institute, division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden | ||
| 726 | EUCTR2011-000612-26-IT (EUCTR) | 19/09/2011 | 05/03/2012 | Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK | Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK | Syndrome Gilles de la Tourette's disease Parkinosn Pounding MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: PROSCAR*30CPR RIV 5MG INN or Proposed INN: Finasteride | AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 727 | NCT01474421 (ClinicalTrials.gov) | September 15, 2011 | 5/10/2011 | Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias | Dyskinesias;Drug-induced | Drug: AQW051;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 71 | Phase 2 | United States;France;Germany;Italy |
| 728 | NCT01178047 (ClinicalTrials.gov) | September 2011 | 6/8/2010 | Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Rasagiline | University of Zurich | H. Lundbeck A/S | Terminated | 40 Years | N/A | Both | 1 | Phase 4 | Switzerland |
| 729 | NCT01515774 (ClinicalTrials.gov) | September 2011 | 10/1/2012 | Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) | An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease | Parkinson's Disease | Drug: Mirapex ER | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 200 | Phase 4 | Korea, Republic of |
| 730 | EUCTR2010-018534-44-HU (EUCTR) | 30/08/2011 | 08/07/2011 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | France;United States;Serbia;Czech Republic;Hungary;Canada;Poland;Romania;Germany;United Kingdom | ||
| 731 | EUCTR2010-020299-42-DE (EUCTR) | 30/08/2011 | 26/04/2011 | A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients. | A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD | Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE | Philipps-University Marburg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Germany | ||
| 732 | EUCTR2009-015162-57-GB (EUCTR) | 16/08/2011 | 26/01/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 733 | EUCTR2009-015162-57-BG (EUCTR) | 04/08/2011 | 09/06/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 734 | EUCTR2010-021394-37-BG (EUCTR) | 04/08/2011 | 02/06/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 735 | EUCTR2010-021860-13-BG (EUCTR) | 04/08/2011 | 02/06/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 736 | NCT01759888 (ClinicalTrials.gov) | August 2011 | 1/1/2013 | Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism | From Mouse Models to Patients: Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 Parkinsonism | Parkinson's Disease | Drug: 18F-DTBZ | Chang Gung Memorial Hospital | National Science Council, Taiwan | Completed | 20 Years | 80 Years | Both | 49 | Phase 2 | Taiwan |
| 737 | NCT01370811 (ClinicalTrials.gov) | August 2011 | 8/6/2011 | A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease | A Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's Disease | Sialorrhoea | Drug: OC oral solution treatment A;Drug: OC oral solution treatment B;Drug: OC oral solution treatment C;Drug: OC oral solution treatment D | Orient Pharma Co., Ltd. | NULL | Completed | 40 Years | 80 Years | Both | 24 | Phase 2 | United States |
| 738 | NCT01411137 (ClinicalTrials.gov) | August 2011 | 4/8/2011 | Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study | An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD | Parkinson's Disease | Drug: IPX066 | Impax Laboratories, LLC | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 43 | Phase 3 | United States |
| 739 | NCT01634568 (ClinicalTrials.gov) | August 2011 | 20/6/2012 | A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men | A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of V81444 in Healthy Male Volunteers | Parkinson's Disease | Drug: V81444 | Vernalis (R&D) Ltd | NULL | Completed | 18 Years | 45 Years | Male | 49 | Phase 1 | United Kingdom |
| 740 | EUCTR2009-015162-57-LT (EUCTR) | 25/07/2011 | 21/04/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 741 | EUCTR2010-021860-13-IT (EUCTR) | 25/07/2011 | 29/03/2012 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: NA Other descriptive name: NA Trade Name: Comtan® INN or Proposed INN: NA | BIAL - PORTELA & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina | |||
| 742 | EUCTR2009-015162-57-LV (EUCTR) | 19/07/2011 | 11/05/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM1) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 743 | EUCTR2010-023756-82-DE (EUCTR) | 13/07/2011 | 28/04/2011 | Study to test influence of parkinson drug of insomnia in parkinson patients | Rasagiline treatment for Sleep disorders in Parkinson´s disease - RaSPar | sleep disturbances/sleep disorders in patients with Parkinson´s disease MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Azilect Other descriptive name: RASAGILINE MESILATE | Dresden University of Technology | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 744 | EUCTR2009-015162-57-SE (EUCTR) | 12/07/2011 | 31/05/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 745 | EUCTR2011-001092-39-DE (EUCTR) | 29/06/2011 | 17/05/2011 | efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesiasin Parkinson’s patients with moderate to severe L-dopa induced dyskinesias | L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AQW051 Product Code: AQW051 Product Name: AQW051 Product Code: AQW051 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;United States;Germany;Italy | |||
| 746 | EUCTR2010-020112-11-LT (EUCTR) | 29/06/2011 | 06/04/2011 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 585 | Phase 3 | United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia | ||
| 747 | EUCTR2010-021860-13-CZ (EUCTR) | 24/06/2011 | 09/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 748 | EUCTR2010-020112-11-LV (EUCTR) | 21/06/2011 | 08/04/2011 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 | Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 585 | Phase 3 | United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia | ||
| 749 | EUCTR2010-022200-46-LV (EUCTR) | 21/06/2011 | 01/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease. | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 750 | EUCTR2009-015162-57-CZ (EUCTR) | 17/06/2011 | 15/04/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 751 | EUCTR2009-015161-31-PL (EUCTR) | 08/06/2011 | 23/02/2011 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 752 | NCT01652534 (ClinicalTrials.gov) | June 2011 | 15/8/2011 | Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease | Efficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Amantadine;Drug: Placebo | Northwestern University | NULL | Terminated | 18 Years | 85 Years | All | 3 | Phase 3 | United States |
| 753 | EUCTR2010-022517-25-DE (EUCTR) | 30/05/2011 | 14/02/2011 | Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 754 | EUCTR2008-005492-94-BG (EUCTR) | 25/05/2011 | 23/03/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 755 | EUCTR2010-021394-37-AT (EUCTR) | 19/05/2011 | 05/01/2011 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 756 | EUCTR2010-022200-46-FI (EUCTR) | 13/05/2011 | 23/03/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Germany;Latvia;Lithuania | |||
| 757 | EUCTR2010-022200-46-LT (EUCTR) | 09/05/2011 | 05/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 758 | EUCTR2007-002964-90-BE (EUCTR) | 05/05/2011 | 04/09/2007 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 759 | EUCTR2010-021394-37-SK (EUCTR) | 02/05/2011 | 16/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 760 | NCT01856439 (ClinicalTrials.gov) | May 2011 | 14/5/2013 | Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease | A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease. | Parkinson's Disease | Drug: ProSavin | Axovant Sciences Ltd. | Oxford BioMedica | Terminated | N/A | N/A | All | 15 | Phase 1/Phase 2 | France;United Kingdom |
| 761 | NCT01504178 (ClinicalTrials.gov) | May 2011 | 30/12/2011 | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Parkinson's Disease | Drug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-Dopa | University Hospital, Toulouse | French Parkinson Association | Completed | 30 Years | 70 Years | All | 28 | Phase 3 | France |
| 762 | NCT01766258 (ClinicalTrials.gov) | May 2011 | 22/11/2012 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Parkinson's Disease | Drug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: Stalevo | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 117 | Phase 2 | NULL |
| 763 | NCT01520987 (ClinicalTrials.gov) | May 2011 | 26/1/2012 | Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects | Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 65 Years | All | 105 | Phase 1 | United States |
| 764 | EUCTR2010-022517-25-AT (EUCTR) | 15/04/2011 | 17/02/2011 | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease | Levodopa induced dyskinesia in Parkinson's disease patients MedDRA version: 14.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ADX48621 Product Code: ADX48621 INN or Proposed INN: Dipraglurant | Addex Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;France;Austria;Germany | ||
| 765 | EUCTR2008-005492-94-PT (EUCTR) | 14/04/2011 | 19/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 766 | EUCTR2009-015161-31-DE (EUCTR) | 04/04/2011 | 24/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 767 | NCT01338896 (ClinicalTrials.gov) | April 2011 | 18/4/2011 | Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations | A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine transdermal patch | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 1 | Austria;Germany;United Kingdom |
| 768 | NCT01937078 (ClinicalTrials.gov) | April 2011 | 26/7/2012 | Famotidine for Levodopa-induced Dyskinesia in PD | An 'N-of-1' Study of the Histamine H@ Antagonist, Famotidine in Levodopa-induced Dyskinesia in Parkinson's Disease | Dyskinesia | Drug: Famotidine | University Health Network, Toronto | NULL | Completed | 18 Years | 80 Years | Both | 7 | Phase 2 | Canada |
| 769 | NCT01336088 (ClinicalTrials.gov) | April 2011 | 4/4/2011 | ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ADX48621;Drug: Placebo | Addex Pharma S.A. | NULL | Completed | 30 Years | 75 Years | Both | 83 | Phase 2 | United States;Austria;France;Germany |
| 770 | NCT01313819 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | Parkinson`s Disease;Freezing of Gait | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 20 | Phase 4 | Korea, Republic of |
| 771 | NCT01323855 (ClinicalTrials.gov) | March 28, 2011 | 24/3/2011 | A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512) | A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment | Parkinson Disease | Drug: Preladenant | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 75 Years | All | 46 | Phase 1 | Germany |
| 772 | EUCTR2009-015162-57-AT (EUCTR) | 17/03/2011 | 03/02/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 773 | EUCTR2008-005492-94-CZ (EUCTR) | 14/03/2011 | 03/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 774 | EUCTR2010-018534-44-DE (EUCTR) | 11/03/2011 | 10/08/2010 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 2 | United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 775 | EUCTR2010-021860-13-DE (EUCTR) | 09/03/2011 | 18/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 776 | EUCTR2010-021394-37-CZ (EUCTR) | 09/03/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 777 | EUCTR2010-021394-37-DE (EUCTR) | 08/03/2011 | 03/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 778 | EUCTR2009-015161-31-GB (EUCTR) | 07/03/2011 | 01/07/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 779 | EUCTR2008-005492-94-FI (EUCTR) | 04/03/2011 | 13/01/2011 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 780 | EUCTR2009-015162-57-FI (EUCTR) | 02/03/2011 | 20/01/2011 | An Active-Controlled Extension Study to P04938 and P07037 (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden | ||
| 781 | NCT01283594 (ClinicalTrials.gov) | March 2011 | 24/1/2011 | Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off | A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off | Parkinson's Disease | Drug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BID | Biotie Therapies Inc. | NULL | Completed | 30 Years | 80 Years | All | 420 | Phase 2/Phase 3 | United States;Argentina;Canada;Chile;Romania;Ukraine |
| 782 | NCT01264861 (ClinicalTrials.gov) | March 2011 | 20/12/2010 | A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging | Open-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease Patients | Parkinson Disease | Drug: Safinamide | Newron | NULL | Terminated | 40 Years | 80 Years | All | 5 | Phase 2 | United States |
| 783 | NCT02169427 (ClinicalTrials.gov) | March 2011 | 24/1/2012 | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral Administration | Parkinson's Disease (PD) | Drug: OPC | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | Male | 6 | Phase 1 | Netherlands |
| 784 | NCT01294800 (ClinicalTrials.gov) | February 25, 2011 | 10/2/2011 | A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402) | A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402) | Parkinson's Disease | Drug: Preladenant;Drug: Placebo tablet to match Preladenant | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 450 | Phase 2 | Japan |
| 785 | EUCTR2008-001329-33-GB (EUCTR) | 24/02/2011 | 15/03/2010 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom | ||
| 786 | EUCTR2009-015161-31-BG (EUCTR) | 17/02/2011 | 02/02/2011 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden | ||
| 787 | EUCTR2010-021860-13-SK (EUCTR) | 17/02/2011 | 09/12/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | |||
| 788 | EUCTR2010-021394-37-ES (EUCTR) | 17/02/2011 | 22/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 | Enfermedad de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: NEUPRO 2 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 4 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 6 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE Trade Name: NEUPRO 8 mg/24 h parche transdérmico INN or Proposed INN: ROTIGOTINA Other descriptive name: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy | ||
| 789 | EUCTR2010-021394-37-HU (EUCTR) | 14/02/2011 | 13/12/2010 | Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinson’s disease | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland | ||
| 790 | EUCTR2009-017174-20-AT (EUCTR) | 09/02/2011 | 07/12/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Canada;France;Austria;South Africa | |||
| 791 | NCT01300819 (ClinicalTrials.gov) | February 2011 | 18/2/2011 | Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms | Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Other: Placebo;Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 349 | Phase 4 | Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland |
| 792 | NCT01296464 (ClinicalTrials.gov) | February 2011 | 14/2/2011 | Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens | Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms | Parkinson's Disease | Drug: Carbidopa | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 27 | Phase 2 | Finland;Sweden |
| 793 | EUCTR2009-015161-31-PT (EUCTR) | 28/01/2011 | 29/10/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 794 | EUCTR2010-021860-13-AT (EUCTR) | 27/01/2011 | 11/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina | |||
| 795 | EUCTR2010-021860-13-RO (EUCTR) | 27/01/2011 | 25/07/2011 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina | ||
| 796 | EUCTR2010-021394-37-BE (EUCTR) | 25/01/2011 | 14/12/2010 | Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptoms | MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro 2mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 4mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 6mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE Trade Name: Neupro 8mg/24h transdermal patch INN or Proposed INN: ROTIGOTINE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 4 | Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland | ||
| 797 | EUCTR2010-021860-13-ES (EUCTR) | 24/01/2011 | 27/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 798 | EUCTR2009-015161-31-CZ (EUCTR) | 17/01/2011 | 28/07/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 799 | EUCTR2010-022915-21-SE (EUCTR) | 12/01/2011 | 18/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 800 | EUCTR2010-022915-21-FI (EUCTR) | 10/01/2011 | 11/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 801 | NCT01229332 (ClinicalTrials.gov) | January 2011 | 3/10/2010 | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients | A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Saline;Drug: Carbidopa | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Israel |
| 802 | EUCTR2010-021860-13-PT (EUCTR) | 22/12/2010 | 08/11/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina | |||
| 803 | EUCTR2010-021860-13-LV (EUCTR) | 22/12/2010 | 14/10/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 804 | EUCTR2008-004146-88-DE (EUCTR) | 20/12/2010 | 15/10/2010 | An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 805 | EUCTR2009-015161-31-NL (EUCTR) | 09/12/2010 | 09/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India | ||
| 806 | EUCTR2009-015161-31-IT (EUCTR) | 06/12/2010 | 28/09/2010 | A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND | A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND | Parkinson`s Disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Product Name: Preladenant Product Code: SCH420814 Trade Name: Azilect INN or Proposed INN: Rasagiline | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 807 | EUCTR2009-015161-31-SE (EUCTR) | 02/12/2010 | 06/10/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 808 | EUCTR2010-020109-34-ES (EUCTR) | 29/11/2010 | 23/09/2010 | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. | Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamida Product Code: NW-1015 Other descriptive name: Safinamida | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 809 | EUCTR2010-020109-34-IT (EUCTR) | 24/11/2010 | 27/12/2010 | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND | Cognition in non-demented patients with idiopathic Parkinson’s disease MedDRA version: 9.1;Level: PT;Classification code 10061536 | Product Name: SAFINAMIDE Product Code: NW-1015 | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain;Italy | ||
| 810 | NCT01227265 (ClinicalTrials.gov) | November 19, 2010 | 22/10/2010 | Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037) | A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease. | Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's Disease | Drug: Preladenant;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 476 | Phase 3 | Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States |
| 811 | NCT01215227 (ClinicalTrials.gov) | November 18, 2010 | 4/10/2010 | An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153) | A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153) | Parkinson Disease;Idiopathic Parkinson Disease | Drug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagiline | Merck Sharp & Dohme Corp. | NULL | Terminated | 30 Years | 85 Years | All | 839 | Phase 3 | Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States |
| 812 | EUCTR2010-021860-13-HU (EUCTR) | 11/11/2010 | 27/09/2010 | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I | Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy | |||
| 813 | EUCTR2007-001109-26-GB (EUCTR) | 04/11/2010 | 05/08/2010 | A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease | A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease | Patients with bilateral, idiopathic Parkinson's Disease | Product Name: ProSavin INN or Proposed INN: ProSavin | Oxford BioMedica (UK) Ltd | NULL | Not Recruiting | Female: yes Male: yes | 27 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 814 | EUCTR2009-015161-31-AT (EUCTR) | 03/11/2010 | 17/08/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 815 | NCT01060878 (ClinicalTrials.gov) | November 2010 | 1/2/2010 | Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD) | Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks | Parkinson's Disease | Drug: PYM50028;Drug: Placebo | Phytopharm | NULL | Completed | 35 Years | 75 Years | Both | 425 | Phase 2 | United States;Canada;Czech Republic;France;Germany;Hungary;Poland;Romania;Serbia;United Kingdom |
| 816 | EUCTR2010-018534-44-GB (EUCTR) | 22/10/2010 | 09/08/2010 | Investigation of Cogane (PYM50028) in early stage Parkinson's disease | A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD | Early-Stage Parkinson’s Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol Product Name: PYM50028 Product Code: PYM50028 INN or Proposed INN: SMILAGENIN Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol | Phytopharm plc | NULL | Not Recruiting | Female: yes Male: yes | 408 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom | ||
| 817 | EUCTR2009-015161-31-FR (EUCTR) | 19/10/2010 | 29/07/2010 | A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease | A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesilate Other descriptive name: RASAGILINE MESILATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 818 | EUCTR2009-015928-28-SE (EUCTR) | 07/10/2010 | 13/08/2010 | A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09 | A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09 | Dyskinesias related to levodopa treatment in Parkinson´s disease | Product Name: Eltoprazine HCl Product Code: Eltoprazine HCl | PsychoGenics Inc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Sweden | |||
| 819 | EUCTR2007-002964-90-CZ (EUCTR) | 06/10/2010 | 27/08/2010 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 820 | EUCTR2010-019418-25-DE (EUCTR) | 01/10/2010 | 19/07/2010 | Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma Sevices AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Canada;Finland;Australia;Germany;Italy;Japan | |||
| 821 | NCT01173731 (ClinicalTrials.gov) | October 2010 | 28/7/2010 | Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | Parkinson Disease;Dyskinesia, Drug-Induced;Levodopa | Drug: AFQ056 | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 66 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Finland;Spain |
| 822 | EUCTR2010-019418-25-FR (EUCTR) | 29/09/2010 | 15/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Finland;Germany;Italy | |||
| 823 | EUCTR2009-017238-39-DE (EUCTR) | 16/09/2010 | 28/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 3 | France;Belgium;Germany;Italy | ||
| 824 | EUCTR2009-017238-39-FR (EUCTR) | 15/09/2010 | 09/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 825 | EUCTR2010-019418-25-FI (EUCTR) | 08/09/2010 | 21/07/2010 | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias | Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 Product Name: AFQ056 Product Code: AFQ065 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 244 | France;Finland;Germany;Italy | |||
| 826 | NCT01211587 (ClinicalTrials.gov) | September 2010 | 28/9/2010 | A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease | A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment | Parkinson's Disease With Cognitive Impairments | Drug: safinamide;Drug: placebo | Newron | NULL | Completed | 45 Years | 80 Years | Both | 103 | Phase 2 | United States;Spain |
| 827 | EUCTR2009-017238-39-BE (EUCTR) | 27/08/2010 | 14/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Nacom 100 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 828 | EUCTR2009-017253-35-GB (EUCTR) | 20/08/2010 | 06/08/2010 | Long-term study of patients who received ProSavin in the PS1/001/07 clinical trial. | A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease | Patients with bilateral, idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ProSavin INN or Proposed INN: ProSavin | Oxford BioMedica (UK) Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 27 | United Kingdom | |||
| 829 | EUCTR2009-015161-31-FI (EUCTR) | 17/08/2010 | 23/06/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Preladenant Product Code: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE Trade Name: Azilect Product Name: Azilect Product Code: N04BD02 INN or Proposed INN: Rasagiline mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden | ||
| 830 | EUCTR2010-020769-25-FR (EUCTR) | 10/08/2010 | 09/07/2010 | Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical | Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Trade Name: DUODOPA INN or Proposed INN: LEVODOPA/CARBIDOPA INN or Proposed INN: LEVODOPA/BENZERASIDE INN or Proposed INN: PERGOLIDE INN or Proposed INN: LISURIDE INN or Proposed INN: BROMOCRIPTINE INN or Proposed INN: ROPINIROLE INN or Proposed INN: PRAMIPEXOLE INN or Proposed INN: IPRONIAZID Other descriptive name: MOCLOBEMIDE INN or Proposed INN: AMANTADINE INN or Proposed INN: CLOZAPINE INN or Proposed INN: SELEGILINE INN or Proposed INN: RASAGILINE INN or Proposed INN: ENTACAPONE INN or Proposed INN: TOLCAPONE | CHU de Poitiers | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 831 | NCT01191944 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients | A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa | Parkinson Disease | Drug: pramipexole immediate release tablet;Drug: pramipexole extended release tablet | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 475 | Phase 3 | China |
| 832 | NCT01824056 (ClinicalTrials.gov) | August 2010 | 12/3/2013 | The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography | The Differential Diagnosis of Parkinson's Disease and Parkinsonism by Positron-emission Tomography With Vesicular Monoamine Transporter Ligand (18F-DTBZ) | Parkinson's Disease | Drug: 18F-FDG | Chang Gung Memorial Hospital | National Science Council, Taiwan | Completed | 20 Years | 80 Years | Both | 120 | Phase 2 | Taiwan |
| 833 | NCT01155466 (ClinicalTrials.gov) | July 14, 2010 | 30/6/2010 | A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938) | A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938) | Parkinson Disease | Drug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsule | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | 85 Years | All | 778 | Phase 3 | Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States |
| 834 | EUCTR2010-018650-12-FR (EUCTR) | 13/07/2010 | 06/05/2010 | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | maladie de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: CYMBALTA Product Name: duloxetine Trade Name: APOKINON Product Name: apomorphine Trade Name: MODOPAR Product Name: levodopa Trade Name: MOTILIUM Product Name: dompéridone | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 835 | NCT01149811 (ClinicalTrials.gov) | July 2010 | 10/6/2010 | A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's Disease | A Randomized, Double-Blind, Crossover Study Comparing the Safety and Tolerability of Two Dose Regimens of Oromucosal Fipamezole ODT in Adult Patients With Parkinson's Disease Who Are Receiving Levodopa | Parkinson's Disease | Drug: Fipamezole ODT;Drug: Fipamezole ODT Cohort 2 | Valeant Pharmaceuticals International, Inc. | NULL | Completed | 30 Years | 75 Years | Both | 27 | United States | |
| 836 | NCT01174004 (ClinicalTrials.gov) | July 2010 | 30/7/2010 | A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate;Drug: placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 199 | Phase 3 | United States;Canada |
| 837 | NCT01435915 (ClinicalTrials.gov) | June 28, 2010 | 1/9/2011 | Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects | A Single Dose and Repeat Dose Study to Investigate the Pharmacokinetics of Ropinirole After Single and Multiple Doses of a PR-formulation in Chinese Healthy Male and Female Subjects | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | All | 24 | Phase 1 | China |
| 838 | EUCTR2009-017238-39-IT (EUCTR) | 21/06/2010 | 13/07/2010 | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536 | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA LEVODOPA Trade Name: NACOM 100 INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone | IMPAX LABORATORIES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Germany;France;Italy | |||
| 839 | EUCTR2009-013886-24-SE (EUCTR) | 08/06/2010 | 21/12/2009 | Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Czech Republic;Germany;Sweden | |||
| 840 | NCT01141023 (ClinicalTrials.gov) | June 2010 | 8/6/2010 | Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease Progression | The Parkinson's Progression Markers Initiative (PPMI) | Parkinson Disease | Drug: DaTscan | Ken Marek, MD | Institute for Neurodegenerative Disorders | Active, not recruiting | 30 Years | N/A | All | 1100 | Phase 2 | United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Norway;Spain;United Kingdom |
| 841 | NCT01140841 (ClinicalTrials.gov) | June 2010 | 8/6/2010 | A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa | A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving Levodopa | Parkinson's Disease | Drug: Fipamezole ODT;Drug: Placebo | Valeant Pharmaceuticals International, Inc. | NULL | Completed | 30 Years | 75 Years | Both | 40 | United States | |
| 842 | NCT01176240 (ClinicalTrials.gov) | June 2010 | 30/7/2010 | A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease | A Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease | Orthostatic Hypotension;Parkinson's Disease | Drug: Droxidopa;Other: Placebo | Chelsea Therapeutics | NULL | Completed | 18 Years | N/A | All | 225 | Phase 3 | United States |
| 843 | EUCTR2009-016143-19-AT (EUCTR) | 26/05/2010 | 12/05/2010 | Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie | Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie | Parkinson's disease | Trade Name: Amantadin-ratiopharm 100mg Other descriptive name: AMANTADINE HYDROCHLORIDE | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | 66 | France;Austria | |||
| 844 | EUCTR2010-019396-29-IT (EUCTR) | 18/05/2010 | 05/03/2012 | Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease. | Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD | Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: STALEVO*100CPR 50/12,5/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor Trade Name: STALEVO*100CPR 100/25/200MG INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor INN or Proposed INN: Levodopa and decarboxylase inhibitor | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 845 | NCT01532115 (ClinicalTrials.gov) | May 2010 | 23/1/2012 | Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women | A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacin | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | Both | 64 | Phase 1 | France |
| 846 | NCT01130493 (ClinicalTrials.gov) | May 2010 | 24/5/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: CLE | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Italy |
| 847 | NCT00988117 (ClinicalTrials.gov) | April 2010 | 29/9/2009 | The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems | The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD) | Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems | Drug: Rivastigmine Patch 9.5 cm2 | University of California, San Francisco | Novartis | Completed | 55 Years | N/A | All | 15 | Phase 4 | United States |
| 848 | NCT01113320 (ClinicalTrials.gov) | April 2010 | 8/4/2010 | Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects | A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias | Parkinson's Disease | Drug: Placebo;Drug: Safinamide | Newron | NULL | Completed | 30 Years | N/A | Both | 26 | Phase 2 | Austria;Canada;France;Germany;South Africa |
| 849 | NCT01103011 (ClinicalTrials.gov) | April 2010 | 12/4/2010 | Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611 | A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611 | Parkinson's Disease | Drug: ND0611 | NeuroDerm Ltd. | NULL | Completed | 18 Years | 50 Years | Male | 8 | Phase 1 | Israel |
| 850 | EUCTR2009-017174-20-DE (EUCTR) | 15/03/2010 | 07/01/2010 | A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study | Idiopathic Parkinson's disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015E, EMD 1195686, MSC2191632B INN or Proposed INN: safinamide Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 24 | France;Canada;Austria;South Africa;Germany | |||
| 851 | EUCTR2009-013886-24-DE (EUCTR) | 03/03/2010 | 29/10/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Czech Republic;Germany;Sweden | |||
| 852 | NCT01503944 (ClinicalTrials.gov) | March 2010 | 14/7/2010 | A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET) | Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers | Dementia With Lewy Bodies;Alzheimer's Disease;Parkinson's Disease | Drug: 18F-AV-133;Drug: 18F-AV-45 | Avid Radiopharmaceuticals | NULL | Completed | 50 Years | N/A | Both | 30 | Phase 1/Phase 2 | United States |
| 853 | NCT01066442 (ClinicalTrials.gov) | March 2010 | 9/2/2010 | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase | Parkinson's Disease | Drug: BF2.649 (Pitolisant) | Bioprojet | NULL | Completed | 30 Years | 80 Years | Both | 273 | Phase 3 | Germany |
| 854 | NCT01092065 (ClinicalTrials.gov) | March 2010 | 22/3/2010 | Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia | A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia | Parkinson's Disease | Drug: AFQ056 with L-dopa;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 23 | Phase 2 | United States |
| 855 | NCT01055379 (ClinicalTrials.gov) | March 2010 | 22/1/2010 | Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn | A Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO Study | Depressive Symptoms;Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Lundbeck Italia S.p.A. | Teva Pharmaceutical Industries | Completed | 40 Years | 80 Years | All | 121 | Phase 4 | Italy |
| 856 | EUCTR2009-017174-20-FR (EUCTR) | 24/02/2010 | 18/01/2010 | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. | Idiopathic Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Austria;Germany | ||
| 857 | EUCTR2007-002963-28-DE (EUCTR) | 17/02/2010 | 22/12/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 858 | EUCTR2009-014688-37-PL (EUCTR) | 09/02/2010 | 20/01/2010 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 859 | EUCTR2009-016360-37-SE (EUCTR) | 06/02/2010 | 04/12/2009 | TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY | TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY | Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries. | Product Name: not available Product Code: OSU 6162 similar to (-)-OSU 6162 INN or Proposed INN: not available | Björn Holmberg | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Sweden | ||
| 860 | EUCTR2008-005492-94-BE (EUCTR) | 25/01/2010 | 12/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 861 | EUCTR2008-005492-94-NL (EUCTR) | 18/01/2010 | 25/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Netherlands;Germany | ||
| 862 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 863 | EUCTR2008-001329-33-CZ (EUCTR) | 18/01/2010 | 03/12/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy | ||
| 864 | NCT01007864 (ClinicalTrials.gov) | January 2010 | 3/11/2009 | Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine Agonists | Influence of the Non-Ergot Dopamine Agonist Piribedil on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Oral Non-Ergot Dopamine Agonists | Idiopathic Parkinson's Disease | Drug: piribedil;Drug: pramipexole or ropinirole | Desitin Arzneimittel GmbH | FGK Clinical Research GmbH | Completed | 35 Years | 80 Years | Both | 80 | Phase 3 | Germany |
| 865 | EUCTR2009-014688-37-ES (EUCTR) | 30/12/2009 | 21/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 866 | EUCTR2009-011541-24-NL (EUCTR) | 30/12/2009 | 29/05/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 867 | EUCTR2009-014688-37-DE (EUCTR) | 15/12/2009 | 07/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 868 | EUCTR2008-005492-94-GB (EUCTR) | 09/12/2009 | 01/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 869 | EUCTR2009-012897-12-RO (EUCTR) | 08/12/2009 | 30/03/2015 | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 | Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE | BIAL-Portela & Ca, SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Romania | |||
| 870 | EUCTR2009-014688-37-FR (EUCTR) | 04/12/2009 | 09/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | France;Poland;Spain;Germany | ||
| 871 | EUCTR2009-012419-16-DE (EUCTR) | 03/12/2009 | 20/10/2009 | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD | idiopathic Parkinson's disease MedDRA version: 12.0;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Clarium 50 mg Retardtabletten INN or Proposed INN: piribedil | Desitin Arzneimittel GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 872 | NCT01049984 (ClinicalTrials.gov) | December 2009 | 13/1/2010 | Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease | A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | Teva Neuroscience, Inc. | H. Lundbeck A/S | Completed | 30 Years | N/A | All | 328 | Phase 4 | United States |
| 873 | NCT00660387 (ClinicalTrials.gov) | December 2009 | 15/4/2008 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 35 | Phase 3 | United States;New Zealand |
| 874 | NCT01036139 (ClinicalTrials.gov) | December 2009 | 11/12/2009 | Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease | A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase | Parkinson's Disease | Drug: BF2.649 (pitolisant) | Bioprojet | NULL | Completed | 30 Years | 80 Years | Both | 268 | Phase 3 | France |
| 875 | NCT01032486 (ClinicalTrials.gov) | December 2009 | 11/12/2009 | Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease | An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects | Parkinson's Disease | Drug: Rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | Both | 120 | Canada | |
| 876 | EUCTR2009-013886-24-CZ (EUCTR) | 26/11/2009 | 18/11/2009 | A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2 | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Germany;Czech Republic;Sweden | ||||
| 877 | EUCTR2008-005492-94-FR (EUCTR) | 25/11/2009 | 01/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 878 | EUCTR2009-013885-14-FR (EUCTR) | 23/11/2009 | 25/09/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase | Excessive daytime sleepiness in Parkinson’s Disease MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 3 | France;Spain | ||
| 879 | EUCTR2008-005492-94-ES (EUCTR) | 23/11/2009 | 18/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 880 | NCT00660673 (ClinicalTrials.gov) | November 13, 2009 | 15/4/2008 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD | Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump | AbbVie | IQVIA, formerly Quintiles | Completed | 30 Years | 99 Years | All | 262 | Phase 3 | United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic |
| 881 | EUCTR2009-013885-14-ES (EUCTR) | 12/11/2009 | 23/09/2009 | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. | A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. | Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism | Product Name: Pitolisant Product Code: BF2.649 INN or Proposed INN: Pitolisant | BIOPROJET | NULL | Not Recruiting | Female: yes Male: yes | 246 | Phase 3 | France;Spain | ||
| 882 | NCT01023282 (ClinicalTrials.gov) | November 2009 | 1/12/2009 | Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients | Randomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary Measure | Parkinson's Disease;Tolerability | Drug: ACR325;Drug: Placebo | NeuroSearch A/S | NULL | Completed | 30 Years | 75 Years | Both | 22 | Phase 1 | Germany |
| 883 | NCT01519284 (ClinicalTrials.gov) | November 2009 | 23/1/2012 | Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic | A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 82 | Phase 1 | Portugal |
| 884 | EUCTR2008-005492-94-HU (EUCTR) | 27/10/2009 | 22/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | |||
| 885 | EUCTR2008-004146-88-PL (EUCTR) | 19/10/2009 | 31/08/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 886 | EUCTR2008-005492-94-SK (EUCTR) | 14/10/2009 | 22/10/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1285 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 887 | EUCTR2009-011541-24-GB (EUCTR) | 09/10/2009 | 29/05/2009 | A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagiline | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands | ||
| 888 | EUCTR2008-001329-33-PT (EUCTR) | 02/10/2009 | 19/08/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 275 | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand | |||
| 889 | EUCTR2008-005492-94-AT (EUCTR) | 02/10/2009 | 03/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 890 | EUCTR2008-005492-94-EE (EUCTR) | 01/10/2009 | 15/09/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 891 | NCT00914095 (ClinicalTrials.gov) | October 2009 | 2/6/2009 | Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II) | Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial | Parkinson's Disease;Gait Disorders, Neurologic;Dementia | Drug: methylphenidate;Drug: placebo | University Hospital, Lille | NULL | Completed | 30 Years | 80 Years | Both | 69 | Phase 4 | France |
| 892 | NCT00957918 (ClinicalTrials.gov) | October 2009 | 11/8/2009 | Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy | Randomized, Double-Blind, Parallel Group, Placebo Controlled Safety, Tolerability and Efficacy Study of NP002 in Subjects With Idiopathic Parkinson's Disease With Dyskinesias Due to Levodopa Therapy | Parkinson's Disease | Drug: nicotine;Other: placebo comparator | Neuraltus Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 83 Years | Both | 65 | Phase 1/Phase 2 | United States |
| 893 | NCT01108029 (ClinicalTrials.gov) | October 2009 | 20/7/2009 | Study of Memantine for Gait Disorders And Attention Deficit In Parkinson's Disease | Study of Memantine to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Monocentric Trial | Parkinson's Disease;Gait Disorders, Neurologic | Drug: memantine;Drug: placebo | University Hospital, Lille | NULL | Completed | 30 Years | 80 Years | Both | 28 | Phase 4 | France |
| 894 | NCT01028586 (ClinicalTrials.gov) | October 2009 | 7/12/2009 | MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) | A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide, MAO-B inhibitor;Drug: Placebo | Newron | NULL | Terminated | 30 Years | 80 Years | Both | 507 | Phase 3 | Switzerland |
| 895 | EUCTR2009-011541-24-DE (EUCTR) | 22/09/2009 | 27/07/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom | |||
| 896 | NCT01371682 (ClinicalTrials.gov) | September 18, 2009 | 10/6/2010 | A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda | An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda | Parkinson Disease | Drug: Ropinirole XL | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | All | 50 | Phase 1 | Belgium |
| 897 | EUCTR2009-011541-24-PT (EUCTR) | 09/09/2009 | 29/07/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 898 | NCT00986414 (ClinicalTrials.gov) | September 2009 | 29/9/2009 | Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Parkinson Disease;Dyskinesias | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 80 Years | All | 260 | Phase 2 | Australia;Canada;Finland;France;Germany;Italy;Japan;Spain |
| 899 | NCT00909883 (ClinicalTrials.gov) | September 2009 | 19/5/2009 | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Foot Dystonia Treatment by Botulinum Toxin Injections in Parkinson Disease : Efficiency of Injections Made in Extrinsic Muscle (Flexor Digitorum Longus Muscle) Compared to Intrinsic Muscle (Flexor Digitorum Brevis or Quadratus Plantae Muscles) | Parkinson's Disease;Foot Dystonia | Drug: Botulinum Toxin: Xeomin;Drug: Placebo | University Hospital, Clermont-Ferrand | Merz Pharma France | Recruiting | 30 Years | 75 Years | Both | 45 | Phase 3 | France |
| 900 | NCT01026428 (ClinicalTrials.gov) | September 2009 | 1/12/2009 | A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics | A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Safinamide + Levodopa;Other: Placebo + Levodopa | Newron | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Italy |
| 901 | NCT00794313 (ClinicalTrials.gov) | September 2009 | 19/11/2008 | Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease | Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease | Parkinson's Disease | Drug: Amantadine 300 mg;Drug: Topiramate;Drug: Sugar Pill | Oregon Health and Science University | NULL | Terminated | 21 Years | N/A | All | 3 | N/A | United States |
| 902 | NCT00903838 (ClinicalTrials.gov) | September 2009 | 14/5/2009 | A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia. | Advanced Stage Parkinson's Disease | Drug: pardoprunox;Drug: pramipexole | Abbott Products | NULL | Terminated | 30 Years | N/A | Both | 37 | Phase 2 | Germany;Italy;Portugal |
| 903 | NCT00986245 (ClinicalTrials.gov) | September 2009 | 24/9/2009 | Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily | An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease | Parkinson Disease | Drug: Ropinirole Prolonged release | Seoul National University Hospital | NULL | Completed | 30 Years | 80 Years | All | 82 | Phase 4 | Korea, Republic of |
| 904 | NCT00974974 (ClinicalTrials.gov) | September 2009 | 10/9/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 471 | Phase 3 | United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine |
| 905 | EUCTR2009-011541-24-ES (EUCTR) | 27/08/2009 | 26/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up | Parkinson's Disease Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT 1 mg comprimidos INN or Proposed INN: RASAGILINA MESILATO Other descriptive name: RASAGILINA MESILATO | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 906 | EUCTR2008-004146-88-BG (EUCTR) | 13/08/2009 | 13/07/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 907 | EUCTR2008-008712-98-DE (EUCTR) | 07/08/2009 | 13/07/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | France;Finland;Spain;Germany;Italy | |||
| 908 | EUCTR2008-004146-88-PT (EUCTR) | 31/07/2009 | 14/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 909 | EUCTR2009-011541-24-FR (EUCTR) | 17/07/2009 | 19/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 910 | EUCTR2009-011541-24-HU (EUCTR) | 10/07/2009 | 05/06/2009 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesylate | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom | ||
| 911 | NCT00909545 (ClinicalTrials.gov) | July 2009 | 26/5/2009 | Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease | A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease | Parkinson Disease | Drug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: Placebo | Northwestern University | Michael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study Group | Completed | 30 Years | N/A | All | 99 | Phase 2 | United States;Canada |
| 912 | NCT00955604 (ClinicalTrials.gov) | July 2009 | 6/8/2009 | Azilect + Antidepressant Chart Review | Investigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart Review | Serotonin Syndrome | Drug: Group R+AD Rasagiline + Antidepressant;Drug: Group R Rasagiline;Drug: Group AD Anti-PD + Antidepressant | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | All | 1500 | N/A | United States |
| 913 | NCT00936676 (ClinicalTrials.gov) | July 2009 | 8/7/2009 | ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO Study | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | Teva Neuroscience, Inc.;H. Lundbeck A/S | Completed | N/A | N/A | Both | 684 | N/A | United States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom |
| 914 | EUCTR2009-011541-24-IT (EUCTR) | 24/06/2009 | 26/06/2009 | An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up | An open-label, multi-center, follow-up study designed to evaluate the long-term effects of rasagiline in Parkinson?s disease subjects who participated in the ADAGIO study - ADAGIO Follow -Up | Parkinson?s disease MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: AZILECT INN or Proposed INN: Rasagiline | Teva Pharmaceutical Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Portugal;France;Hungary;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 915 | EUCTR2008-001966-10-EE (EUCTR) | 16/06/2009 | 13/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 916 | EUCTR2008-004146-88-ES (EUCTR) | 16/06/2009 | 16/04/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 917 | EUCTR2008-008712-98-FR (EUCTR) | 10/06/2009 | 28/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Other descriptive name: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | France;Finland;Spain;Germany;Italy | |||
| 918 | EUCTR2009-012529-12-FR (EUCTR) | 10/06/2009 | 18/05/2009 | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: REQUIP-LP Product Name: ropinirole Trade Name: REQUIP Product Name: ropinirole | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | France | |||
| 919 | EUCTR2008-004146-88-CZ (EUCTR) | 08/06/2009 | 07/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 920 | EUCTR2009-010193-38-LV (EUCTR) | 04/06/2009 | 24/08/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 921 | NCT00921128 (ClinicalTrials.gov) | June 2, 2009 | 13/6/2009 | Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s Disease | Convection Enhanced Delivery of Muscimol to Study the Pathophysiology Underlying the Clinical Features of Parkinson's Disease | Parkinson's Disease | Drug: Muscimol | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 922 | EUCTR2009-010193-38-LT (EUCTR) | 02/06/2009 | 26/03/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 923 | NCT00833690 (ClinicalTrials.gov) | June 2009 | 27/1/2009 | Safety of Urate Elevation in Parkinson's Disease | A Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease | Parkinson Disease | Drug: Placebo;Drug: inosine | The Parkinson Study Group | Massachusetts General Hospital;Harvard School of Public Health;University of Rochester;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 75 | Phase 2 | United States |
| 924 | EUCTR2008-001966-10-AT (EUCTR) | 27/05/2009 | 08/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 925 | EUCTR2008-004146-88-IT (EUCTR) | 26/05/2009 | 27/04/2009 | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study | Idiopatic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Safinamide INN or Proposed INN: Safinamide Product Name: Safinamide INN or Proposed INN: Safinamide | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 926 | EUCTR2008-001966-10-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Other descriptive name: NW-1015 Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Estonia;Hungary;Slovakia;Austria;United Kingdom | ||
| 927 | EUCTR2008-004146-88-SK (EUCTR) | 25/05/2009 | 28/05/2009 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 928 | EUCTR2008-004146-88-FI (EUCTR) | 19/05/2009 | 06/04/2009 | An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist | A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 498 | Phase 3 | United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany | ||
| 929 | EUCTR2008-008712-98-FI (EUCTR) | 18/05/2009 | 08/04/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | moderate to severe levodopa induced dyskinesias in patients with Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 198 | Finland;Germany;France;Spain;Italy | |||
| 930 | EUCTR2008-008712-98-IT (EUCTR) | 14/05/2009 | 05/05/2009 | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND | moderate to severe levodopa induced dyskinesia with Parkinson`s disease MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia | Product Code: AFQ056 Product Code: AFQ056 Product Code: AFQ056 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 234 | Finland;Germany;France;Spain;Italy | |||
| 931 | EUCTR2008-001966-10-GB (EUCTR) | 12/05/2009 | 27/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 932 | EUCTR2008-000400-81-DE (EUCTR) | 11/05/2009 | 29/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 933 | EUCTR2009-010193-38-EE (EUCTR) | 07/05/2009 | 15/04/2009 | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 934 | EUCTR2008-001966-10-HU (EUCTR) | 04/05/2009 | 06/04/2009 | A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 416 | Phase 3 | Hungary;United Kingdom;Estonia;Austria | |||
| 935 | EUCTR2007-002963-28-BG (EUCTR) | 03/05/2009 | 21/05/2009 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 936 | NCT01515891 (ClinicalTrials.gov) | May 2009 | 19/1/2012 | Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral Administration | Parkinson Disease | Drug: BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 40 Years | 55 Years | Male | 4 | Phase 1 | Switzerland |
| 937 | NCT00767546 (ClinicalTrials.gov) | May 2009 | 5/10/2008 | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian Patients | Parkinson Disease;Parkinsonism;Seborrheic Dermatitis | Drug: Botulinum toxin | Rabin Medical Center | NULL | Not yet recruiting | 18 Years | N/A | Both | 40 | Phase 1 | NULL |
| 938 | EUCTR2008-002769-30-IT (EUCTR) | 30/04/2009 | 22/04/2009 | A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics | A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics | Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113 | Product Name: Safinamide INN or Proposed INN: Safinamide INN or Proposed INN: NACOM levodopa+cardidopa | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 939 | EUCTR2008-005492-94-IT (EUCTR) | 30/04/2009 | 15/04/2009 | OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND | OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND | IDIOPATHIC PARKINSON`S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: SAFINAMIDE Product Code: NW-1015 Product Name: SAFINAMIDE Product Code: NW-1015 | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands | ||
| 940 | EUCTR2007-001095-36-SK (EUCTR) | 09/04/2009 | 09/04/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Phase 3 | Hungary;Slovakia | ||
| 941 | EUCTR2008-005085-30-DE (EUCTR) | 06/04/2009 | 04/03/2009 | Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline | Einfluss von Rasagilin auf das Riechvermögen von Patienten mit idiopathischem Parkinson-Syndrom(Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline) - Olfaction | Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III MedDRA version: 13.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Azilect INN or Proposed INN: Rasagilin | Technische Universität Dresden | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 942 | EUCTR2008-000400-81-PT (EUCTR) | 03/04/2009 | 27/01/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia | Advanced Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex Product Name: pramipexole INN or Proposed INN: pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate Trade Name: Mirapex Product Name: Pramipexole INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals BV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 943 | EUCTR2007-002963-28-PL (EUCTR) | 02/04/2009 | 27/02/2009 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy | ||
| 944 | EUCTR2007-004235-37-AT (EUCTR) | 02/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 945 | EUCTR2007-002964-90-AT (EUCTR) | 02/04/2009 | 13/02/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 946 | JPRN-JapicCTI-090888 | 01/4/2009 | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | Parkinson's Disease Treated Concomitantly with L-dopa | Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. | Otsuka Pharmaceutical Co., Ltd. | NULL | 30 | 79 | BOTH | 400 | Phase 3 | NULL | ||
| 947 | JPRN-UMIN000001841 | 2009/04/01 | 02/04/2009 | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life | A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life - RCT with vitamin D for Parkinson disease | Parkinson disease | Vitamin D3 placebo | Jikei University School of Medicine | NULL | Complete: follow-up complete | 45years-old | 85years-old | Male and Female | 120 | Not selected | Japan |
| 948 | NCT00875316 (ClinicalTrials.gov) | April 2009 | 2/4/2009 | Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients | A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month | Parkinson's Disease | Drug: Cogane™ (PYM50028) | Phytopharm | NULL | Completed | 40 Years | 80 Years | Both | 36 | Phase 1 | United Kingdom |
| 949 | NCT00865579 (ClinicalTrials.gov) | April 2009 | 10/3/2009 | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Parkinson's Disease | Drug: Safinamide | Newron | NULL | Terminated | 30 Years | N/A | All | 964 | Phase 3 | Romania |
| 950 | NCT01568034 (ClinicalTrials.gov) | April 2009 | 29/3/2012 | A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | All | 10 | Phase 2 | Portugal;Romania;Ukraine |
| 951 | NCT00880620 (ClinicalTrials.gov) | April 2009 | 3/4/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine |
| 952 | EUCTR2008-000400-81-IT (EUCTR) | 31/03/2009 | 17/04/2009 | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND | Advanced Parkinson`s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole Trade Name: Mirapex INN or Proposed INN: Pramipexole | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Portugal;Germany;Italy | |||
| 953 | EUCTR2007-003035-22-AT (EUCTR) | 30/03/2009 | 26/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 560 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 954 | EUCTR2007-002963-28-PT (EUCTR) | 26/03/2009 | 07/01/2009 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 955 | EUCTR2007-002964-90-FR (EUCTR) | 09/03/2009 | 12/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 956 | NCT00888004 (ClinicalTrials.gov) | March 2009 | 23/4/2009 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients | A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias | Parkinson's Disease;L-dopa Induced Dyskinesia | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany |
| 957 | NCT00823836 (ClinicalTrials.gov) | March 2009 | 15/1/2009 | Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease | Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole PR/XR;Drug: ropinirole IR | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 302 | Phase 3 | Japan |
| 958 | NCT00870974 (ClinicalTrials.gov) | March 2009 | 26/3/2009 | A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions | Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions | Parkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive Impairment | Drug: [18F]FPEB | Institute for Neurodegenerative Disorders | NULL | Completed | 18 Years | 85 Years | All | 48 | Phase 1 | United States |
| 959 | NCT00940914 (ClinicalTrials.gov) | March 2009 | 16/7/2009 | Dopaminergic Loss and Pain in Parkinson's Disease | Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain | Parkinson's Disease;Pain | Drug: ioflupane 123I (DATSCAN®) | University Hospital, Toulouse | NULL | Completed | 30 Years | 70 Years | All | 20 | Phase 2 | France |
| 960 | NCT00866502 (ClinicalTrials.gov) | March 2009 | 18/3/2009 | A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump. | Parkinson's Disease | Drug: sNN0031;Drug: Placebo | Newron Sweden AB | Medtronic;Quintiles | Completed | 30 Years | 75 Years | Both | 12 | Phase 1/Phase 2 | Sweden |
| 961 | NCT00767091 (ClinicalTrials.gov) | March 2009 | 1/9/2008 | Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric Trial | Parkinson's Disease;Apathy;no Dementia | Drug: rivastigmine;Drug: placebo | University Hospital, Lille | NULL | Completed | 15 Years | 80 Years | Both | 40 | Phase 3 | France |
| 962 | EUCTR2008-006278-13-NL (EUCTR) | 04/02/2009 | 15/10/2008 | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. | patients with advanced (>5 years) Parkinson's disease and visual hallucinations. MedDRA version: 9.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations MedDRA version: 9.1;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Reminyl Retard Trade Name: Sinemet 125 mg | UMCG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Netherlands | |||
| 963 | NCT01421719 (ClinicalTrials.gov) | February 2009 | 19/8/2011 | Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease | Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy | Parkinson's Disease;Neurogenic Bladder;Urinary Incontinence;Clostridium Botulinum Toxin Adverse Reaction | Drug: Cystoscopic injection of Botox into the urinary bladder | Stanford University | Allergan | Completed | 50 Years | 85 Years | All | 20 | Phase 4 | United States |
| 964 | NCT00806468 (ClinicalTrials.gov) | February 2009 | 9/12/2008 | Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease | Parkinson Disease | Drug: Desmotabs | Johannes Gutenberg University Mainz | NULL | Terminated | 18 Years | 85 Years | Male | 1 | Phase 4 | Germany |
| 965 | NCT00627640 (ClinicalTrials.gov) | February 2009 | 13/2/2008 | Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa | A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine | Idiopathic Parkinson's Disease | Drug: Safinimide 50-100 mg/day;Drug: Matching Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 549 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom |
| 966 | EUCTR2007-007853-30-SE (EUCTR) | 28/01/2009 | 21/12/2007 | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. | Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III) | Product Name: sNN0031 Product Code: sNN0031 | NeuroNova AB | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 967 | EUCTR2009-015833-66-IT (EUCTR) | 20/01/2009 | 18/04/2012 | Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release | Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: REQUIP*28CPR 8MG R.P. INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: REQUIP*21CPR 5MG INN or Proposed INN: ROPINIROLE Other descriptive name: NA Trade Name: MIRAPEXIN*30CPR 0,7MG INN or Proposed INN: PRAMIPEXOLE Other descriptive name: NA | CASA DI CURA PRIVATA S.RAFFAELE - PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 968 | EUCTR2007-002963-28-CZ (EUCTR) | 19/01/2009 | 30/10/2007 | A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany | ||
| 969 | EUCTR2007-003035-22-PT (EUCTR) | 09/01/2009 | 01/07/2008 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/A | ACADIA Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | ||
| 970 | EUCTR2007-003035-22-IT (EUCTR) | 07/01/2009 | 23/07/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015 | Psychosis in Parkinson?s Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: primavanserin tartrate Product Code: ACP-103 INN or Proposed INN: primavanserin tartrate | ACADIA PHARMACEUTICALS INC. | NULL | Not Recruiting | Female: yes Male: yes | 486 | Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden | ||||
| 971 | EUCTR2008-004906-15-FR (EUCTR) | 05/01/2009 | 16/03/2009 | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson | Maladie de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DATSCAN | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 972 | NCT00357994 (ClinicalTrials.gov) | January 2009 | 27/7/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 36 | Phase 3 | United States;Germany |
| 973 | EUCTR2004-000148-26-AT (EUCTR) | 31/12/2008 | 26/11/2008 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
| 974 | EUCTR2008-003966-25-DE (EUCTR) | 23/12/2008 | 04/11/2008 | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA | Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Trade Name: Desmotabs® 0,2 mg Tabletten Product Name: Desmotabs® 0,2mg Tabletten INN or Proposed INN: Desmopressin Acetat | Universität Mainz, Klinik und Poliklinik für Neurologie | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 975 | NCT00809302 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) | Early Parkinson Disease | Drug: aplindore MR tablets or Placebo | Neurogen Corporation | NULL | Terminated | 30 Years | N/A | Both | 9 | Phase 2 | United States |
| 976 | EUCTR2008-004943-12-SK (EUCTR) | 24/11/2008 | 10/10/2008 | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study | Early Stage Parkinson’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Other descriptive name: SLV308 hydrochloride Trade Name: Mirapex INN or Proposed INN: Pramipexole Other descriptive name: pramipexole dihydrochloride monohydrate | Solvay Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Slovakia | ||
| 977 | EUCTR2007-003051-36-BE (EUCTR) | 06/11/2008 | 21/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Austria;Sweden;Portugal;Spain;Belgium | |||
| 978 | EUCTR2007-003035-22-GB (EUCTR) | 05/11/2008 | 20/12/2007 | A safety and tolerability study of ACP-103 in patients with Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015 | Psychosis in Parkinson's Disease MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate Other descriptive name: N/a | ACADIA Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden | ||
| 979 | NCT00869791 (ClinicalTrials.gov) | November 2008 | 24/3/2009 | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 27 | Phase 2 | United States |
| 980 | EUCTR2008-003869-72-PT (EUCTR) | 03/10/2008 | 25/06/2008 | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR | Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067 | Bial - Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Portugal | |||
| 981 | EUCTR2007-000350-31-IT (EUCTR) | 02/10/2008 | 11/02/2008 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND | mild to moderately severe dementia associated with Parkinson?s disease (PDD) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Trade Name: EXELON INN or Proposed INN: Rivastigmine Product Name: Exelon path transdermal Product Code: ENA713B INN or Proposed INN: Rivastigmine | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 982 | NCT01048229 (ClinicalTrials.gov) | October 2008 | 12/1/2010 | Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease | Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's Disease | Early-stage Parkinson's Disease | Drug: Rasagiline;Drug: Pramipexole | Qualissima | H. Lundbeck A/S | Terminated | 18 Years | 70 Years | Both | 112 | Phase 4 | NULL |
| 983 | NCT00906828 (ClinicalTrials.gov) | October 2008 | 19/5/2009 | Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors | Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors | Parkinson Disease | Drug: levodopa/carbidopa;Drug: entacapone;Drug: tolcapone | Uppsala University | Swedish Parkinson's Disease Foundation;Swedish Society for Medical Research | Completed | 30 Years | 90 Years | Both | 10 | Phase 4 | Sweden |
| 984 | EUCTR2008-003225-16-FI (EUCTR) | 10/09/2008 | 30/05/2008 | Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla | Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla | Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS | Trade Name: Duodopa | Organisation name was not entered | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 985 | EUCTR2007-003051-36-AT (EUCTR) | 10/09/2008 | 29/04/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 986 | EUCTR2007-003051-36-PT (EUCTR) | 05/09/2008 | 27/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 987 | EUCTR2007-003035-22-BE (EUCTR) | 02/09/2008 | 21/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 988 | EUCTR2007-004235-37-GB (EUCTR) | 19/08/2008 | 26/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 989 | EUCTR2004-005234-39-DE (EUCTR) | 11/08/2008 | 02/12/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 990 | NCT00643890 (ClinicalTrials.gov) | August 2008 | 24/3/2008 | Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease | Phase 2 Safety and Efficacy Study Evaluating Glutamic Acid Decarboxylase Gene Transfer to Subthalamic Nuclei in Subjects With Advanced Parkinson's Disease | Parkinson's Disease | Genetic: Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus | Neurologix, Inc. | NULL | Terminated | 30 Years | 75 Years | Both | 44 | Phase 2 | United States |
| 991 | EUCTR2004-000148-26-HU (EUCTR) | 26/07/2008 | 19/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Finland;Hungary;Czech Republic;Spain;Italy;Sweden | ||
| 992 | EUCTR2008-003581-26-SE (EUCTR) | 18/07/2008 | 30/05/2008 | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa Trade Name: Comtess INN or Proposed INN: entacapone Trade Name: Tasmar INN or Proposed INN: tolcapone | Dept of Neuroscience, Uppsala University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Sweden | ||||
| 993 | EUCTR2007-003051-36-ES (EUCTR) | 01/07/2008 | 05/05/2008 | Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psicosis en la enfermedad de Parkinson.Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 994 | EUCTR2007-003051-36-SE (EUCTR) | 30/06/2008 | 16/05/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Portugal;Spain;Austria;Sweden | |||
| 995 | EUCTR2007-002963-28-IT (EUCTR) | 30/06/2008 | 04/01/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: safinamide Product Name: safinamide | MERCK SERONO INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 666 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 996 | EUCTR2007-003035-22-SE (EUCTR) | 11/06/2008 | 16/05/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: pimavanserin (ACP-103) INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2;Phase 3 | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 997 | EUCTR2007-002964-90-HU (EUCTR) | 03/06/2008 | 15/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A.-Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 998 | NCT00822913 (ClinicalTrials.gov) | June 2008 | 14/1/2009 | Botulinum A Toxin in Patients With Parkinson's Disease | The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity. | Parkinson's Disease;Multiple System Atrophy;Detrusor Overactivity | Drug: Intravesical injection of Botulinum A toxin | University Of Perugia | University of Roma La Sapienza | Enrolling by invitation | 18 Years | 80 Years | Both | 20 | Phase 4 | NULL |
| 999 | EUCTR2007-004235-37-PL (EUCTR) | 29/05/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden | |||
| 1000 | EUCTR2006-006752-35-DE (EUCTR) | 06/05/2008 | 23/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1001 | EUCTR2007-004235-37-SE (EUCTR) | 23/04/2008 | 25/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 1002 | EUCTR2007-002906-23-BG (EUCTR) | 16/04/2008 | 07/07/2008 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | United Kingdom;France;Bulgaria | |||
| 1003 | EUCTR2007-001096-10-SK (EUCTR) | 11/04/2008 | 09/04/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Slovakia | ||
| 1004 | NCT02071810 (ClinicalTrials.gov) | April 2008 | 19/1/2012 | Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 34 | Phase 1 | France |
| 1005 | NCT00605553 (ClinicalTrials.gov) | April 2008 | 15/1/2008 | Study to Evaluate SYN115 in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: Tozadenant | Biotie Therapies Inc. | NULL | Completed | 40 Years | 75 Years | All | 30 | Phase 2 | United States |
| 1006 | NCT00753636 (ClinicalTrials.gov) | April 2008 | 13/9/2008 | Parkinson's Disease Isradipine Safety Study | Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II | Parkinson's Disease | Drug: Dynacirc CR (Isradipine) | Northwestern University | Northwestern Memorial Hospital | Completed | 30 Years | 75 Years | All | 31 | Phase 2 | United States |
| 1007 | EUCTR2007-001095-36-HU (EUCTR) | 27/03/2008 | 06/02/2008 | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 625 | Hungary | |||
| 1008 | EUCTR2006-003732-30-PL (EUCTR) | 27/03/2008 | 08/01/2008 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Early Parkinson's Disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Name: Lisuride TTS 10cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,088 INN or Proposed INN: PRAMIPEXOLE Product Name: Lisuride TTS 20cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,18 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,35 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,7 INN or Proposed INN: PRAMIPEXOLE | NeuroBiotec Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 1009 | EUCTR2007-001096-10-HU (EUCTR) | 27/03/2008 | 15/02/2008 | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study | advanced stage of idiopathic PD with dose-dependent motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 INN or Proposed INN: Pardoprunox hydrochloride Product Name: Pardoprunox Product Code: SLV308 | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 500 | Hungary | |||
| 1010 | EUCTR2007-002964-90-GB (EUCTR) | 20/03/2008 | 14/01/2009 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 1011 | EUCTR2007-004235-37-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 1012 | NCT00727727 (ClinicalTrials.gov) | March 2008 | 31/7/2008 | SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K) | Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices. | Parkinson's Disease | Drug: Piribedil | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 750 | N/A | Germany |
| 1013 | NCT00607451 (ClinicalTrials.gov) | March 2008 | 22/1/2008 | Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia | A Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced Dyskinesia | Levodopa-induced Dyskinesia | Drug: Neu-120 | Neurim Pharmaceuticals Ltd. | NULL | Terminated | 30 Years | 80 Years | All | 8 | Phase 1/Phase 2 | Israel |
| 1014 | NCT00761137 (ClinicalTrials.gov) | March 2008 | 25/9/2008 | Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients | Sialorrhea Secondary to Parkinson's Disease | Drug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamide | NeuroHealing Pharmaceuticals Inc. | Michael J. Fox Foundation for Parkinson's Research | Completed | 50 Years | 80 Years | All | 19 | Phase 2 | Argentina |
| 1015 | EUCTR2007-003035-22-FR (EUCTR) | 29/02/2008 | 15/02/2008 | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 486 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden | ||
| 1016 | EUCTR2007-002964-90-DE (EUCTR) | 28/02/2008 | 17/12/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 484 | Phase 3 | France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom | ||
| 1017 | EUCTR2007-000350-31-ES (EUCTR) | 13/02/2008 | 21/12/2007 | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) | Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | France;Spain;Italy | ||
| 1018 | EUCTR2007-002964-90-EE (EUCTR) | 13/02/2008 | 02/01/2008 | A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine. | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 1019 | NCT00888186 (ClinicalTrials.gov) | February 2008 | 24/4/2009 | Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics | Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics | Parkinson Disease;Dyskinesias | Drug: levodopa/carbidopa | Uppsala University | Swedish Parkinson's Disease Foundation;Swedish Society for Medical Research | Completed | 30 Years | 90 Years | Both | 5 | Phase 4 | Sweden |
| 1020 | NCT00624741 (ClinicalTrials.gov) | February 2008 | 15/2/2008 | Compassionate Use Study of Pergolide in Patients With Parkinson's Disease | Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease | Parkinson Disease | Drug: Pergolide | Valeant Pharmaceuticals International, Inc. | NULL | No longer available | N/A | N/A | Both | N/A | NULL | |
| 1021 | EUCTR2007-004235-37-ES (EUCTR) | 24/01/2008 | 08/03/2010 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 1022 | EUCTR2007-002467-27-GB (EUCTR) | 24/01/2008 | 26/11/2007 | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate | Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 13.1;Classification code 10061536;Term: Parkinson's disease;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders | Product Name: Topiramate INN or Proposed INN: TOPIRAMATE | Salford Royal NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 1023 | EUCTR2007-000350-31-FR (EUCTR) | 22/01/2008 | 25/10/2007 | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). | Mild to moderately severe dementia associated with Parkinson’s disease (PDD). MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon INN or Proposed INN: rivastigmine Trade Name: Exelon 4.6 mg/24 h transdermal patch INN or Proposed INN: rivastigmine Trade Name: Exelon 9.5 mg/24 h transdermal patch INN or Proposed INN: rivastigmine | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 550 | France;Spain;Italy | |||
| 1024 | EUCTR2006-006752-35-IT (EUCTR) | 21/01/2008 | 24/04/2007 | PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER | PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER | Idiopathic Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro Trade Name: Neupro | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 336 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1025 | EUCTR2007-004235-37-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden | |||
| 1026 | EUCTR2007-002964-90-ES (EUCTR) | 18/01/2008 | 30/11/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 1027 | EUCTR2007-002963-28-ES (EUCTR) | 17/01/2008 | 16/11/2007 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1036 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 1028 | EUCTR2007-004235-37-SK (EUCTR) | 14/01/2008 | 16/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 1029 | NCT00627588 (ClinicalTrials.gov) | January 2008 | 31/1/2008 | Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's Disease | A Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease. | Parkinson's Disease | Biological: ProSavin | Oxford BioMedica | NULL | Completed | 48 Years | 65 Years | Both | 15 | Phase 1/Phase 2 | France;United Kingdom |
| 1030 | NCT00623103 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD) | A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD) | Parkinson's Disease Dementia | Drug: Rivastigmine capsule;Drug: Rivastigmine transdermal patch | Novartis | NULL | Completed | 50 Years | 85 Years | All | 583 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom |
| 1031 | NCT00623324 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease | A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Aplindore;Drug: Placebo | Ligand Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 40 | Phase 2 | United States |
| 1032 | NCT00725478 (ClinicalTrials.gov) | January 2008 | 28/7/2008 | SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease | Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices. | Parkinson's Disease | Drug: Piribedil | Desitin Arzneimittel GmbH | NULL | Completed | 18 Years | N/A | Both | 250 | N/A | NULL |
| 1033 | EUCTR2006-003732-30-IT (EUCTR) | 31/12/2007 | 13/02/2008 | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I | Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: lisuride TTS INN or Proposed INN: Lisuride Trade Name: mirapexin INN or Proposed INN: Pramipexole | NEUROBIOTEC GMBH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 1034 | EUCTR2007-004654-81-GB (EUCTR) | 20/12/2007 | 16/10/2007 | A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients | A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients | Sialorrhoea associated with Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10059812;Term: Sialorrhoea | Trade Name: Catapres ampoules INN or Proposed INN: Clonidine hydrochloride Trade Name: Ditropan elixir INN or Proposed INN: Oxybutynin hydrochloride | Summit (Cambridge) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 1035 | EUCTR2007-000801-30-HU (EUCTR) | 20/12/2007 | 15/11/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 1036 | EUCTR2006-006907-35-IT (EUCTR) | 19/12/2007 | 20/04/2007 | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER | Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: rotigotine INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 1037 | EUCTR2004-000185-12-GB (EUCTR) | 13/12/2007 | 11/02/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Finland;Austria;Italy;United Kingdom;Sweden | ||
| 1038 | EUCTR2007-002963-28-FI (EUCTR) | 12/12/2007 | 18/10/2007 | A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist. | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals SpA | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany | ||
| 1039 | EUCTR2007-002964-90-NL (EUCTR) | 11/12/2007 | 11/12/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 1040 | EUCTR2007-002963-28-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 839 | Phase 3 | Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy | ||
| 1041 | EUCTR2007-002964-90-SK (EUCTR) | 06/12/2007 | 16/04/2008 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 540 | Phase 3 | France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 1042 | EUCTR2007-002964-90-FI (EUCTR) | 04/12/2007 | 18/10/2007 | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa | Ideopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1121 | Phase 3 | Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria | ||
| 1043 | EUCTR2007-004985-41-SE (EUCTR) | 29/11/2007 | 10/10/2007 | Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study | Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study | Parkinson's disease, G20.9. Different dyskinesias related to advanced Parkinson's disease will be investigated. | Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa | Department of Neuroscience, neurology | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 1044 | EUCTR2007-000801-30-ES (EUCTR) | 29/11/2007 | 12/09/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras | Parkinson's DiseaseEnfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Poland;Spain;Lithuania;Latvia;Italy | ||
| 1045 | EUCTR2007-002906-23-GB (EUCTR) | 14/11/2007 | 15/08/2007 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | United Kingdom;Bulgaria;France | |||
| 1046 | ChiCTR-TRC-07000027 | 2007-11-01 | 2007-11-09 | A randomized controlled clinical study of Pramipexole for Parkinson's disease | A randomized controlled clinical study of Pramipexole for Parkinson's disease | Primary Parkinson's disease | Group 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease; | First Affiliated Hospital of Xinjiang Medical University | NULL | Completed | 30 | 80 | Both | Group 1:45;Group 3:45;Group 2:45; | China | |
| 1047 | NCT00605683 (ClinicalTrials.gov) | November 2007 | 19/12/2007 | MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist | A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide (as add-on therapy) | Newron | NULL | Completed | 30 Years | 80 Years | Both | 679 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel |
| 1048 | NCT00558337 (ClinicalTrials.gov) | November 2007 | 12/11/2007 | Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease | An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients | Parkinson's Disease | Drug: levodopa-carbidopa | Osmotica Pharmaceutical Corp. | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | Argentina |
| 1049 | NCT00632762 (ClinicalTrials.gov) | November 2007 | 20/2/2008 | Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK) | Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK. | Parkinson's Disease | Drug: mantadix | University Hospital, Toulouse | NULL | Completed | 30 Years | 80 Years | Both | 80 | Phase 4 | France |
| 1050 | NCT00560508 (ClinicalTrials.gov) | November 2007 | 16/11/2007 | A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period | A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER | Parkinson Disease | Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 1 Year | N/A | All | 112 | Phase 2/Phase 3 | Japan |
| 1051 | EUCTR2007-002906-23-FR (EUCTR) | 25/10/2007 | 21/08/2007 | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Psychosis in Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS | Product Name: Pimavanserin tartrate Product Code: ACP-103 INN or Proposed INN: Pimavanserin tartrate | Acadia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2;Phase 3 | France;Bulgaria;United Kingdom | ||
| 1052 | EUCTR2007-001717-42-FR (EUCTR) | 25/10/2007 | 11/09/2007 | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A | Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Product Name: SCH 420814 Product Code: N/A | Schering Plough Research Institute | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Spain | ||
| 1053 | EUCTR2007-003353-90-NL (EUCTR) | 23/10/2007 | 07/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | France;Germany;Netherlands | ||
| 1054 | EUCTR2007-000801-30-FR (EUCTR) | 22/10/2007 | 23/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy | ||
| 1055 | EUCTR2007-003353-90-FR (EUCTR) | 17/10/2007 | 27/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | BOEHRINGER INGELHEIM | NULL | Not Recruiting | Female: yes Male: yes | 145 | Phase 3 | France;Germany;Netherlands | ||
| 1056 | EUCTR2006-006907-35-GB (EUCTR) | 09/10/2007 | 26/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1057 | EUCTR2005-005791-32-SE (EUCTR) | 04/10/2007 | 30/07/2007 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom;Sweden | |||
| 1058 | EUCTR2007-002900-16-DE (EUCTR) | 01/10/2007 | 21/08/2007 | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa | The main objective of this study is to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias. | Product Code: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 34 | Germany | |||
| 1059 | NCT01520727 (ClinicalTrials.gov) | October 2007 | 18/1/2012 | A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects | A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 64 | Phase 1 | France |
| 1060 | NCT00582673 (ClinicalTrials.gov) | October 2007 | 21/12/2007 | Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa | A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa | Parkinson's Disease | Drug: AFQ056;Drug: Placebo | Novartis | NULL | Completed | 30 Years | 85 Years | Both | 31 | Phase 2 | Germany |
| 1061 | NCT00559871 (ClinicalTrials.gov) | October 2007 | 15/11/2007 | Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients. | Parkinson's Disease | Drug: fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States;India |
| 1062 | NCT00642928 (ClinicalTrials.gov) | October 2007 | 21/3/2008 | Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients | Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD) | Excessive Daytime Sleepiness;Parkinson's Disease | Drug: Placebo;Drug: BF 2.649 5 mg;Drug: BF 2.649 10 mg;Drug: BF 2.649 20 mg;Drug: BF 2.649 40 mg | Bioprojet | NULL | Completed | 18 Years | N/A | Both | 108 | Phase 2 | France |
| 1063 | NCT00558025 (ClinicalTrials.gov) | October 2007 | 12/11/2007 | Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease | A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR | Parkinson Disease | Drug: Pramipexole Extended Release;Drug: Pramipexole Immediate Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 156 | Phase 3 | France;Germany;Netherlands |
| 1064 | EUCTR2006-002937-20-HU (EUCTR) | 20/09/2007 | 17/05/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1065 | EUCTR2007-002874-75-IT (EUCTR) | 10/09/2007 | 14/01/2008 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 | Psycosis associated to Parkinson's Disease MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC | Product Name: Melperon | OVATION PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
| 1066 | EUCTR2007-000801-30-LT (EUCTR) | 07/09/2007 | 05/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 1067 | EUCTR2007-003353-90-DE (EUCTR) | 05/09/2007 | 08/08/2007 | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. | Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Pramipexole Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 132 | Germany;Netherlands;France | |||
| 1068 | NCT00524914 (ClinicalTrials.gov) | September 2007 | 4/9/2007 | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study. | Parkinson's Disease | Drug: apomorphine;Drug: placebo | University Hospital, Toulouse | NULL | Completed | 30 Years | 70 Years | Both | 16 | N/A | France |
| 1069 | EUCTR2007-000801-30-PL (EUCTR) | 29/08/2007 | 17/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | Spain;Poland;Lithuania;Latvia;Italy;France;Hungary;Estonia;Czech Republic | ||
| 1070 | EUCTR2007-003512-57-FR (EUCTR) | 24/08/2007 | 23/07/2007 | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) | Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease | Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 Product Name: BF 2.649 Product Code: BF 2.649 | Bioprojet | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | France | ||
| 1071 | EUCTR2007-000801-30-EE (EUCTR) | 22/08/2007 | 17/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 1072 | EUCTR2006-000859-18-DE (EUCTR) | 13/08/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania | |||
| 1073 | EUCTR2007-000074-23-HU (EUCTR) | 10/08/2007 | 01/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 1074 | EUCTR2007-000801-30-CZ (EUCTR) | 01/08/2007 | 15/06/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 1075 | NCT00335374 (ClinicalTrials.gov) | August 2007 | 8/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 202 | Phase 3 | United States;Australia;Czech Republic;Estonia;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Taiwan;Thailand;France;Spain;United Kingdom |
| 1076 | NCT00407095 (ClinicalTrials.gov) | August 2007 | 30/11/2006 | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 140 | Phase 3 | United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 1077 | EUCTR2007-000801-30-LV (EUCTR) | 27/07/2007 | 05/07/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 726 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania | |||
| 1078 | EUCTR2006-006752-35-GB (EUCTR) | 23/07/2007 | 13/01/2009 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH, UCB Group | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1079 | EUCTR2007-000801-30-IT (EUCTR) | 17/07/2007 | 13/11/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND | Parkinson's Disease Subjects with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 726 | Phase 3 | France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy | ||
| 1080 | EUCTR2006-005318-11-FR (EUCTR) | 06/07/2007 | 10/05/2007 | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | maladie de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: APOKINON | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1081 | NCT00593606 (ClinicalTrials.gov) | July 2007 | 21/12/2007 | Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine | A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 124 | Phase 3 | NULL |
| 1082 | NCT00556764 (ClinicalTrials.gov) | July 2007 | 8/11/2007 | Development of Cognitive Assessment Tools in Parkinson Disease | Development of Cognitive Assessment Tools in Parkinson Disease | Parkinson Disease | Drug: [123I] IBVM and SPECT imaging;Drug: Subjects will undergo the 123-I IBVM imaging visit | Institute for Neurodegenerative Disorders | Department of Defense;University of Oklahoma | Completed | 30 Years | N/A | Both | 75 | Phase 0 | United States |
| 1083 | NCT00505622 (ClinicalTrials.gov) | July 2007 | 9/7/2007 | Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: Perampanel | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 328 | Phase 3 | France |
| 1084 | NCT00550238 (ClinicalTrials.gov) | July 2007 | 26/10/2007 | A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 459 | Phase 3 | United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom |
| 1085 | NCT00519532 (ClinicalTrials.gov) | July 2007 | 21/8/2007 | Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease | A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Terminated | 18 Years | N/A | All | 84 | Phase 3 | United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria |
| 1086 | NCT00515437 (ClinicalTrials.gov) | July 2007 | 10/8/2007 | A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients | Drooling | Biological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to Myobloc | Solstice Neurosciences | NULL | Completed | 18 Years | 85 Years | All | 54 | Phase 2 | United States |
| 1087 | NCT00522379 (ClinicalTrials.gov) | July 2007 | 28/8/2007 | Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch | A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 514 | Phase 3 | United States;Chile;India;Mexico;Peru |
| 1088 | EUCTR2006-006752-35-HU (EUCTR) | 22/06/2007 | 12/04/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1089 | EUCTR2007-000073-39-CZ (EUCTR) | 18/06/2007 | 18/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 1090 | EUCTR2006-000678-57-CZ (EUCTR) | 18/06/2007 | 02/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1091 | EUCTR2007-000074-23-CZ (EUCTR) | 18/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 1092 | EUCTR2007-000074-23-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 1093 | EUCTR2007-000073-39-HU (EUCTR) | 14/06/2007 | 31/05/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Finland;Hungary;Czech Republic;Austria | ||
| 1094 | EUCTR2007-000073-39-SK (EUCTR) | 14/06/2007 | 09/04/2008 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Finland;Austria;Germany | ||
| 1095 | EUCTR2006-005861-21-IT (EUCTR) | 11/06/2007 | 05/01/2007 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. | Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Italy | ||
| 1096 | EUCTR2006-006684-22-FR (EUCTR) | 08/06/2007 | 27/03/2007 | Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK | Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK | maladie de parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10013916;Term: Dyskinesia | Trade Name: MANTADIX | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1097 | EUCTR2006-000858-45-SE (EUCTR) | 05/06/2007 | 04/04/2007 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 1098 | JPRN-UMIN000000780 | 2007/06/01 | 01/08/2007 | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease - The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | Parkinson's disease | An observation period (2 to 3 weeks) An administration of amantadine hydrochloride (27 days) A wash out period (15 days) An administration of placebo (27 days) An observation period (2 to 3 weeks) An administration of placebo (27 days) A wash out period (15 days) An administration of amantadine hydrochloride (27 days) | Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders | Musashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University Hospital | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 60 | Not applicable | Japan |
| 1099 | NCT00477672 (ClinicalTrials.gov) | June 2007 | 22/5/2007 | A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate (ACP-103);Drug: Placebo | ACADIA Pharmaceuticals Inc. | NULL | Completed | 40 Years | N/A | All | 298 | Phase 3 | United States;Bulgaria;France;India;Russian Federation;Ukraine;United Kingdom |
| 1100 | EUCTR2007-000074-23-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 1101 | EUCTR2007-000073-39-AT (EUCTR) | 30/05/2007 | 05/06/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma Ges mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 1102 | EUCTR2007-000074-23-ES (EUCTR) | 29/05/2007 | 02/03/2010 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. | Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 1103 | EUCTR2007-000073-39-DE (EUCTR) | 29/05/2007 | 26/02/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Czech Republic;Finland;Austria;Germany | ||
| 1104 | EUCTR2006-006907-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1105 | EUCTR2006-006752-35-ES (EUCTR) | 27/05/2007 | 27/03/2007 | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover | Enfermedad de Parkinson(Parkinson's disease) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1106 | EUCTR2007-000074-23-IT (EUCTR) | 17/05/2007 | 06/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND | Patients with advanced idiopathic Parkinson s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Product Name: Pramipexole ER Product Code: SND 919 CL2Y Trade Name: Sifrol Trade Name: Sifrol | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 1107 | EUCTR2006-006907-35-HU (EUCTR) | 17/05/2007 | 12/04/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Finland;Hungary;United Kingdom;Germany;Spain;Italy;Austria | ||
| 1108 | EUCTR2007-000074-23-GB (EUCTR) | 11/05/2007 | 29/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 1109 | EUCTR2006-006752-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1110 | EUCTR2006-006907-35-FI (EUCTR) | 09/05/2007 | 21/03/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 1111 | EUCTR2007-000074-23-SE (EUCTR) | 02/05/2007 | 02/04/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). | Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Product Name: Pramipexole ER Product Code: SND 919 CL2Y INN or Proposed INN: Pramipexole Trade Name: SIFROL INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 1 | Hungary;United Kingdom;Spain;Italy;Austria;Sweden | ||
| 1112 | NCT00479401 (ClinicalTrials.gov) | May 2007 | 25/5/2007 | Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD). | Early Parkinson Disease (Early PD) | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 539 | Phase 3 | United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil |
| 1113 | NCT00477802 (ClinicalTrials.gov) | May 2007 | 22/5/2007 | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease | Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design Study | Parkinson Disease | Biological: Botulinum Toxin Type A;Biological: Placebo | University of Cincinnati | Allergan | Terminated | 35 Years | 75 Years | Both | 8 | Phase 4 | United States |
| 1114 | NCT00474058 (ClinicalTrials.gov) | May 2007 | 14/5/2007 | Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine | Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 287 | Phase 3 | United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom |
| 1115 | NCT00489255 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment | A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo | Parkinson's Disease | Drug: Tigan®;Drug: Placebo | Ipsen | INC Research Limited | Completed | 18 Years | N/A | All | 117 | Phase 4 | United States |
| 1116 | NCT00505843 (ClinicalTrials.gov) | May 2007 | 24/7/2007 | A Study of MK0657 in Parkinson's Disease Patients (0657-006) | A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease | Parkinson's Disease | Drug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopa | Merck Sharp & Dohme Corp. | NULL | Completed | 40 Years | 80 Years | Both | 18 | Phase 1 | United States |
| 1117 | EUCTR2006-002937-20-ES (EUCTR) | 27/04/2007 | 26/04/2007 | Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras | Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras | Enfermedad de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1118 | EUCTR2006-000577-29-DE (EUCTR) | 27/04/2007 | 12/10/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate Trade Name: Sinemet®25-100 INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate | Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories) | NULL | Not Recruiting | Female: yes Male: yes | 31 | United States;Germany | |||
| 1119 | EUCTR2006-002339-26-PT (EUCTR) | 27/04/2007 | 07/03/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1120 | EUCTR2007-000073-39-FI (EUCTR) | 25/04/2007 | 06/03/2007 | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) | Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet Product Name: Pramipexole ER Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Other descriptive name: Prolonged release tablet | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 1121 | EUCTR2006-002339-26-ES (EUCTR) | 19/04/2007 | 30/01/2007 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. | Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1122 | EUCTR2006-006907-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
| 1123 | EUCTR2006-006752-35-AT (EUCTR) | 17/04/2007 | 21/05/2007 | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24 h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24 h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24 h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy | ||
| 1124 | EUCTR2006-002339-26-DE (EUCTR) | 10/04/2007 | 22/12/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1125 | NCT00459420 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Parkinson's Disease;Excessive Daytime Somnolence | Drug: Caffeine 100-200 mg BID;Drug: placebo | Ron Postuma | Canadian Institutes of Health Research (CIHR);University of Toronto | Completed | 18 Years | N/A | Both | 58 | Phase 2/Phase 3 | Canada |
| 1126 | NCT00438607 (ClinicalTrials.gov) | April 2007 | 20/2/2007 | Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa | Parkinson's Disease | Drug: BIIB014;Drug: Placebo | Biogen Idec | NULL | Completed | 30 Years | N/A | Both | 83 | Phase 2 | India;Israel;United Kingdom |
| 1127 | NCT00466167 (ClinicalTrials.gov) | April 2007 | 25/4/2007 | Pivotal Study in Advanced Parkinsons Disease Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD). | Parkinson Disease | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 517 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 1128 | NCT00460148 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole | An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany;South Africa |
| 1129 | EUCTR2006-006209-94-DE (EUCTR) | 15/03/2007 | 26/01/2007 | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Trade Name: Requip-Modutab Product Name: Requip-Modutab Product Code: SK&F101468 INN or Proposed INN: Ropinirole Product Name: Ropinirole Product Code: SK&F101468 INN or Proposed INN: Ropinirole | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany | |||
| 1130 | EUCTR2006-002937-20-FR (EUCTR) | 12/03/2007 | 12/02/2007 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Phase 3 | France;Hungary;Czech Republic;Estonia;Spain;Lithuania;Latvia;Italy | ||
| 1131 | NCT01693081 (ClinicalTrials.gov) | March 2007 | 21/9/2012 | Phase IIa Multicentre Study Investigating of VR040 in Parkinson's Disease | A Clinic-Based, Phase IIa, Double-Blind, Placebo- Controlled, Ascending-Dose, Multicentre Study of Safety, Tolerability, Efficacy and Pharmacokinetics of VR040 in Parkinson's Disease | Parkinson's Disease | Drug: VR040/Aspirair® inhaler;Drug: placebo | South Glasgow University Hospitals NHS Trust | Vectura Limited | Completed | 30 Years | 90 Years | Both | 47 | Phase 2 | Serbia;United Kingdom |
| 1132 | NCT00406588 (ClinicalTrials.gov) | March 2007 | 30/11/2006 | SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations. | Advanced Stage Parkinson's Disease | Drug: Pardoprunox;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 295 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine |
| 1133 | NCT00437125 (ClinicalTrials.gov) | March 2007 | 16/2/2007 | Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease | An Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's Disease | Major Depressive Disorder;Idiopathic Parkinson Disease | Drug: Duloxetine hydrochloride | Eli Lilly and Company | NULL | Completed | 30 Years | 75 Years | All | 151 | Phase 4 | Italy |
| 1134 | NCT00451633 (ClinicalTrials.gov) | March 2007 | 21/3/2007 | The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Withdrawn | 30 Years | 80 Years | Both | 0 | Phase 2 | Germany;Italy |
| 1135 | NCT00443872 (ClinicalTrials.gov) | March 2007 | 3/3/2007 | Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists | Adding Orally Disintegrating Selegiline (Zelapar) to Patients Taking Dopamine Agonists and Experiencing Complications | Parkinson's Disease | Drug: orally disintegrating selegiline (Zelapar) | Parkinson's Disease and Movement Disorder Center of Boca Raton | Valeant Pharmaceuticals International, Inc. | Completed | 30 Years | 90 Years | All | 77 | Phase 4 | United States |
| 1136 | EUCTR2006-005714-12-IT (EUCTR) | 27/02/2007 | 03/08/2007 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005 | Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 1137 | EUCTR2005-002038-36-GR (EUCTR) | 27/02/2007 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1138 | EUCTR2006-005183-91-LT (EUCTR) | 14/02/2007 | 20/12/2006 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 220 | Latvia;Lithuania | |||
| 1139 | EUCTR2006-005182-20-LT (EUCTR) | 13/02/2007 | 20/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| 1140 | EUCTR2006-005182-20-LV (EUCTR) | 02/02/2007 | 28/12/2006 | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 280 | Latvia;Lithuania | |||
| 1141 | EUCTR2006-005183-91-LV (EUCTR) | 02/02/2007 | 11/01/2007 | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study | An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study | Advanced stage Parkinson's disease with motor fluctuations. | Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride Product Name: SLV308(mono)hydrochloride Product Code: SLV308(mono)hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Latvia;Lithuania | |||
| 1142 | NCT00332917 (ClinicalTrials.gov) | February 2007 | 1/6/2006 | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients | Early Stage Parkinson's Disease | Drug: Pardoprunox | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 224 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro |
| 1143 | NCT00427011 (ClinicalTrials.gov) | February 2007 | 24/1/2007 | A Study of E2007 In Patients With Parkinson's Disease | A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 1144 | EUCTR2006-003732-30-DE (EUCTR) | 31/01/2007 | 29/11/2006 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 | Early Parkinson's Disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Name: Lisuride TTS 10cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,088 INN or Proposed INN: PRAMIPEXOLE Product Name: Lisuride TTS 20cm² INN or Proposed INN: LISURIDE Trade Name: Sifrol 0,18 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,35 INN or Proposed INN: PRAMIPEXOLE Trade Name: Sifrol 0,7 INN or Proposed INN: PRAMIPEXOLE | Axxonis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Germany;Italy;Poland | |||
| 1145 | EUCTR2006-000859-18-NL (EUCTR) | 25/01/2007 | 05/04/2007 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 247 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 1146 | EUCTR2006-002339-26-HU (EUCTR) | 24/01/2007 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1147 | EUCTR2006-000678-57-FR (EUCTR) | 09/01/2007 | 10/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | Portugal;France;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom | ||
| 1148 | EUCTR2006-000859-18-PT (EUCTR) | 04/01/2007 | 18/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 1149 | NCT00640159 (ClinicalTrials.gov) | January 2007 | 18/3/2008 | Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease | Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease. | Parkinson's Disease | Drug: Zelapar | Baylor College of Medicine | NULL | Completed | 30 Years | 90 Years | Both | 55 | Phase 4 | United States |
| 1150 | NCT00465452 (ClinicalTrials.gov) | January 2007 | 24/4/2007 | Impact of Switching to Continuous Release Dopamine Agonists | The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects | Parkinson Disease | Drug: Continuous Release Dopamine Agonists | University of Toledo Health Science Campus | NULL | Completed | 55 Years | N/A | Both | 15 | Phase 3 | United States |
| 1151 | NCT01187966 (ClinicalTrials.gov) | January 2007 | 31/5/2010 | Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease | A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 669 | Phase 3 | NULL |
| 1152 | EUCTR2006-000678-57-PT (EUCTR) | 29/12/2006 | 10/08/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1153 | EUCTR2006-002339-26-GB (EUCTR) | 28/12/2006 | 16/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1154 | EUCTR2006-000678-57-DE (EUCTR) | 22/12/2006 | 06/10/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 376 | Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1155 | EUCTR2006-005509-79-GB (EUCTR) | 21/12/2006 | 07/12/2006 | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periods | Product Name: apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United Kingdom | ||
| 1156 | EUCTR2006-003490-27-GB (EUCTR) | 19/12/2006 | 29/09/2006 | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa | Parkinson's disease MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Product Code: BIIB014 Product Code: BIIB014 Product Code: BIIB014 | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 137 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1157 | EUCTR2006-005860-14-IT (EUCTR) | 19/12/2006 | 17/03/2009 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND | PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Safinamide Product Code: NW-1015 Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy | ||
| 1158 | EUCTR2006-000858-45-FI (EUCTR) | 18/12/2006 | 26/06/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Sweden | |||
| 1159 | EUCTR2006-002339-26-IT (EUCTR) | 16/12/2006 | 05/06/2007 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Levodopa treated Parkinson's Disease Patients with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 1160 | EUCTR2006-002937-20-CZ (EUCTR) | 14/12/2006 | 24/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1161 | EUCTR2006-002937-20-EE (EUCTR) | 11/12/2006 | 19/10/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1162 | EUCTR2006-005140-89-NL (EUCTR) | 11/12/2006 | 01/12/2006 | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study | This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD). MedDRA version: 9.1;Level: PT;Classification code 10061536 | Trade Name: Selegiline HCl 5 PCH Trade Name: Nardil Product Name: Rasagiline 1mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate Product Name: Rasagiline 2 mg tablet Product Code: TVP-1012 INN or Proposed INN: Rasagiline Other descriptive name: Rasagiline mesilate | TEVA Pharmaceuticals Industries Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 4 | Netherlands | ||
| 1163 | EUCTR2006-002937-20-LT (EUCTR) | 04/12/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone INN or Proposed INN: entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1164 | NCT01964573 (ClinicalTrials.gov) | December 2006 | 14/10/2013 | Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects | A Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean Subjects | Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB Pharma | NULL | Completed | 19 Years | 45 Years | Both | 48 | Phase 1 | Korea, Republic of |
| 1165 | NCT00406029 (ClinicalTrials.gov) | November 20, 2006 | 30/11/2006 | Dyskinesia in Parkinson's Disease (Study P04501) | A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias | Parkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain Diseases | Drug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatments | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | N/A | All | 253 | Phase 2 | Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States |
| 1166 | EUCTR2006-001755-36-GB (EUCTR) | 20/11/2006 | 29/09/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom;Sweden | ||
| 1167 | EUCTR2006-004112-51-IT (EUCTR) | 14/11/2006 | 04/12/2006 | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | Parkinson s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: SIRIO*30CPR EFF 25MG+100MG INN or Proposed INN: Melevodopa and decarboxylase inhibitor Trade Name: SINEMET*50CPR 100MG+25MG INN or Proposed INN: LEVODOPA DC.IT FU INN or Proposed INN: CARBIDOPA FU | VERNALIS DEVELOPMENT LIMITED | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1168 | EUCTR2006-000678-57-GB (EUCTR) | 14/11/2006 | 30/05/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydro | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom | ||
| 1169 | EUCTR2006-001793-24-PT (EUCTR) | 07/11/2006 | 31/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 1170 | EUCTR2006-000859-18-LT (EUCTR) | 07/11/2006 | 07/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 1171 | EUCTR2006-000678-57-LT (EUCTR) | 07/11/2006 | 07/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1172 | EUCTR2006-000678-57-EE (EUCTR) | 03/11/2006 | 01/09/2006 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1173 | EUCTR2006-000859-18-EE (EUCTR) | 03/11/2006 | 01/09/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 1174 | EUCTR2006-002339-26-CZ (EUCTR) | 01/11/2006 | 21/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1175 | EUCTR2006-002937-20-LV (EUCTR) | 01/11/2006 | 02/11/2006 | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: E2007 Product Code: MARS Trade Name: Comtess Product Name: Entacapone | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 702 | Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania | |||
| 1176 | NCT00491998 (ClinicalTrials.gov) | November 2006 | 26/6/2007 | PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets | Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets | Parkinson's Disease | Drug: V1512;Drug: V1512 and Entacapone | Vernalis (R&D) Ltd | Cita NeuroPharmaceuticals;INC Research | Completed | 30 Years | N/A | Both | 27 | Phase 1/Phase 2 | Italy |
| 1177 | NCT00387075 (ClinicalTrials.gov) | November 2006 | 10/10/2006 | A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease | Parkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson Disease | Parkinson Disease | Procedure: [123I]ß-CIT and SPECT imaging;Drug: [123I]ß-CIT | Institute for Neurodegenerative Disorders | United States Department of Defense;Molecular NeuroImaging | Active, not recruiting | 50 Years | N/A | All | 3000 | Phase 2 | United States |
| 1178 | NCT00400634 (ClinicalTrials.gov) | November 2006 | 15/11/2006 | Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease | Multicenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]);Procedure: Sham Surgery | Sangamo Therapeutics | Ceregene | Completed | 35 Years | 75 Years | All | 58 | Phase 2 | United States |
| 1179 | NCT00468078 (ClinicalTrials.gov) | November 2006 | 30/4/2007 | Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients | The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients | Parkinson's Disease | Procedure: PET/CT;Drug: F-18 FPCIT | Asan Medical Center | NULL | Completed | 40 Years | N/A | Both | 78 | Phase 3 | Korea, Republic of |
| 1180 | NCT00360308 (ClinicalTrials.gov) | November 2006 | 2/8/2006 | Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Placebo;Drug: E2007 | Eisai Limited | NULL | Terminated | 30 Years | N/A | All | 723 | Phase 3 | France |
| 1181 | NCT00335166 (ClinicalTrials.gov) | November 2006 | 8/6/2006 | SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease | A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease. | Early Stage Parkinson Disease | Drug: Pardaprunox;Drug: pramipexole;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 330 | Phase 3 | United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom |
| 1182 | EUCTR2005-002038-36-GB (EUCTR) | 31/10/2006 | 09/10/2006 | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies | Patients with Parkinson’s disease dementia or dementia with Lewy Bodies MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Code: Lu 00-800 INN or Proposed INN: memantine hydrochloride | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Greece;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1183 | EUCTR2006-002339-26-EE (EUCTR) | 20/10/2006 | 15/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1184 | EUCTR2006-002339-26-SE (EUCTR) | 19/10/2006 | 22/09/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden | |||
| 1185 | EUCTR2006-002339-26-BE (EUCTR) | 16/10/2006 | 24/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1186 | EUCTR2006-000858-45-SK (EUCTR) | 11/10/2006 | 28/09/2006 | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochlo | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Finland;Sweden | ||
| 1187 | EUCTR2006-002339-26-LT (EUCTR) | 05/10/2006 | 07/08/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1188 | NCT00590122 (ClinicalTrials.gov) | October 2006 | 28/12/2007 | Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study | COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL | Parkinson's Disease | Drug: Parcopa;Drug: carbidopa-levodopa | Baylor College of Medicine | UCB Pharma | Completed | 31 Years | 80 Years | Both | 20 | Phase 4 | United States |
| 1189 | NCT00360412 (ClinicalTrials.gov) | October 2006 | 2/8/2006 | A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Terminated | 30 Years | N/A | Male | 997 | Phase 3 | Germany |
| 1190 | NCT00391898 (ClinicalTrials.gov) | October 2006 | 24/10/2006 | Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off | A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa | Parkinson's Disease | Drug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopa | Novartis | NULL | Completed | 30 Years | 80 Years | All | 95 | Phase 4 | Spain |
| 1191 | NCT03103399 (ClinicalTrials.gov) | September 26, 2006 | 28/3/2017 | Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon | A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide | Parkinson Disease | Drug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 30 Years | 80 Years | All | 254 | Phase 2 | NULL |
| 1192 | EUCTR2006-002339-26-AT (EUCTR) | 25/09/2006 | 18/10/2006 | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. | Levodopa treated Parkinson's disease patients with motor fluctuations. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania | |||
| 1193 | EUCTR2006-000678-57-IT (EUCTR) | 14/09/2006 | 26/06/2007 | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND | Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: Pramipexole INN or Proposed INN: Pramipexole Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 Product Name: SLV308 (mono)hydrochloride Product Code: SLV308 | SOLVAY PHARMACEUTICALS B.V. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1194 | EUCTR2005-005146-39-IT (EUCTR) | 14/09/2006 | 06/12/2006 | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND | Moderate to severe Parkinson s disease with motor fluctuation and dyskinesias. MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Code: SCH 420814 Product Code: SCH 420814 | Schering Plough Research Institute | NULL | Not Recruiting | Female: yes Male: yes | 160 | Italy | |||
| 1195 | EUCTR2006-000859-18-CZ (EUCTR) | 11/09/2006 | 02/08/2006 | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study | Parkinson's Disease Early stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 225 | Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania | |||
| 1196 | EUCTR2005-004949-34-SE (EUCTR) | 06/09/2006 | 27/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1197 | EUCTR2004-005234-39-LV (EUCTR) | 06/09/2006 | 29/09/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 1198 | EUCTR2005-001006-12-CZ (EUCTR) | 06/09/2006 | 24/08/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 1199 | NCT00507715 (ClinicalTrials.gov) | September 2006 | 25/7/2007 | Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk | Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk | Parkinson's Disease, Idiopathic | Drug: Plantago ovata husk;Other: hemicellulose crystalline | Rottapharm Spain | NULL | Completed | 60 Years | 80 Years | Both | 18 | Phase 1 | Spain |
| 1200 | NCT00208611 (ClinicalTrials.gov) | September 2006 | 13/9/2005 | Vitamin B12 Status and Response to Vitamin B12 Supplementation in Patients With Parkinson's Disease | Assessment of Cobalamin Status and Responses to Supplementation in Patients With Parkinson's Disease : a Pilot Study | Parkinson's Disease | Dietary Supplement: Vitamin B12 Supplementation | Emory University | National Institutes of Health (NIH) | Terminated | 21 Years | N/A | Both | 57 | Phase 2/Phase 3 | United States |
| 1201 | NCT00462007 (ClinicalTrials.gov) | September 2006 | 17/4/2007 | Study to Evaluate Initiation of Stalevo in Early Wearing-off | Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients | Parkinson's Disease | Drug: Stalevo | Orion Corporation, Orion Pharma | NULL | Completed | 35 Years | N/A | Both | 115 | Phase 4 | Germany;Sweden;United Kingdom |
| 1202 | EUCTR2005-006033-32-SE (EUCTR) | 15/08/2006 | 22/06/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 1203 | EUCTR2006-001755-36-SE (EUCTR) | 09/08/2006 | 30/06/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma, FI-02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden | |||
| 1204 | EUCTR2005-004314-33-PT (EUCTR) | 09/08/2006 | 10/05/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1205 | EUCTR2005-004949-34-DE (EUCTR) | 04/08/2006 | 30/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: SIFROL Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1206 | EUCTR2006-000678-57-NL (EUCTR) | 03/08/2006 | 04/04/2007 | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study | Parkinson 's Disease early stage MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochlori | Solvay pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 330 | Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania | |||
| 1207 | NCT00368108 (ClinicalTrials.gov) | August 2006 | 22/8/2006 | Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparator | Eisai Inc. | NULL | Completed | 30 Years | N/A | All | 752 | Phase 3 | United States;Canada |
| 1208 | EUCTR2006-001793-24-AT (EUCTR) | 31/07/2006 | 24/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 1209 | EUCTR2006-000391-32-NL (EUCTR) | 18/07/2006 | 10/05/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Germany;Netherlands;United Kingdom | ||
| 1210 | NCT03097211 (ClinicalTrials.gov) | July 17, 2006 | 27/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Nebicapone | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 38 | Phase 1 | Portugal |
| 1211 | EUCTR2006-003717-41-IT (EUCTR) | 13/07/2006 | 12/07/2007 | EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND | EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND | MOOD DEPRESSION MedDRA version: 6.1;Level: PT;Classification code 10012374 | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 1212 | EUCTR2006-000680-28-ES (EUCTR) | 07/07/2006 | 22/05/2006 | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Enfermedad de Parkinson (Parkinson Disease) | Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA | NOVARTIS FARMACEUTICA, S.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Spain | |||
| 1213 | EUCTR2006-000391-32-DE (EUCTR) | 04/07/2006 | 27/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Netherlands | |||
| 1214 | NCT00354133 (ClinicalTrials.gov) | July 2006 | 19/7/2006 | Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease | The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study) | Parkinson Disease | Device: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical Treatment | German Parkinson Study Group (GPS) | University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS Netzwerk | Active, not recruiting | 18 Years | 60 Years | All | 251 | Phase 4 | France;Germany |
| 1215 | NCT00408915 (ClinicalTrials.gov) | July 2006 | 5/12/2006 | Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion | Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy | Parkinson's Disease | Drug: Continuous Subcutaneous Lisuride Infusion | Axxonis Pharma AG | NULL | Completed | 18 Years | 75 Years | Both | 60 | Phase 3 | Germany |
| 1216 | EUCTR2006-000361-11-GB (EUCTR) | 23/06/2006 | 01/02/2006 | A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) | A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) | Treatment of Parkinson's Disease MedDRA version: 8.0;Classification code 10029205 | Product Name: FPFS-1169 INN or Proposed INN: R-(-)-1-(benzofuran-2-yl)-2-propylaminopentane hydrochloride | Fujimoto Pharmaceutical Corporation | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1217 | EUCTR2005-004314-33-DE (EUCTR) | 21/06/2006 | 01/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1218 | EUCTR2005-004949-34-GB (EUCTR) | 19/06/2006 | 24/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1219 | EUCTR2005-006033-32-SK (EUCTR) | 13/06/2006 | 02/05/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 1220 | EUCTR2006-000391-32-GB (EUCTR) | 06/06/2006 | 21/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Netherlands;Germany;United Kingdom | ||
| 1221 | NCT00269516 (ClinicalTrials.gov) | June 2006 | 22/12/2005 | SLV308 for Treatment of Patients With Early Parkinson's Disease | A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: pardoprunox;Drug: Pardoprunox;Drug: Placebo | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 468 | Phase 3 | United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro |
| 1222 | EUCTR2005-004949-34-ES (EUCTR) | 29/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol, Mirapexin Product Name: Sifrol, Mirapexin Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1223 | NCT00302146 (ClinicalTrials.gov) | May 23, 2006 | 11/3/2006 | Positron Emission Tomography (PET) Imaging in People With Gaucher Mutations | Functional Imaging in Subjects With Glucocerebrosidase Mutations | Parkinson Disease;Gaucher Disease | Drug: 15-0 H20 | National Human Genome Research Institute (NHGRI) | NULL | Completed | 18 Years | N/A | All | 64 | United States | |
| 1224 | EUCTR2005-004314-33-ES (EUCTR) | 19/05/2006 | 15/03/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1225 | EUCTR2005-004949-34-FI (EUCTR) | 17/05/2006 | 21/04/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim | Boehringer Ingelheim Finland Ky | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1226 | EUCTR2004-005234-39-LT (EUCTR) | 09/05/2006 | 24/03/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania | |||
| 1227 | NCT00321854 (ClinicalTrials.gov) | May 2006 | 3/5/2006 | Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD) | A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease. | Parkinson Disease | Drug: pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | 79 Years | All | 535 | Phase 4 | United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom |
| 1228 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 1229 | EUCTR2005-005791-32-GB (EUCTR) | 24/04/2006 | 17/02/2006 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom;Sweden | ||
| 1230 | EUCTR2005-006033-32-FI (EUCTR) | 20/04/2006 | 06/03/2006 | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study | Parkinson's Disease Early Stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Other descriptive name: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 440 | Finland;Slovakia;Sweden | |||
| 1231 | EUCTR2005-004949-34-AT (EUCTR) | 18/04/2006 | 21/03/2006 | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study | Parkinson's disease MedDRA version: 6.1;Level: pref;Classification code 10061536 | Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden | |||
| 1232 | EUCTR2005-001006-12-AT (EUCTR) | 02/04/2006 | 28/02/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 1233 | NCT00461942 (ClinicalTrials.gov) | April 2006 | 17/4/2007 | Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | Parkinson's Disease | Drug: Green Tea Polyphenols (EGCG/ECG) | Xuanwu Hospital, Beijing | Ministry of Health, China;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | Both | 480 | Phase 2 | China |
| 1234 | EUCTR2005-001032-72-PT (EUCTR) | 23/03/2006 | 11/11/2005 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Parkinson disease | Trade Name: Stalevo Product Code: ELC200 INN or Proposed INN: levodopa/carbidopa/entacapone Trade Name: SINEMET Product Name: sinemet INN or Proposed INN: levodopa/carbidopa | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 1235 | EUCTR2005-001006-12-DE (EUCTR) | 09/03/2006 | 05/09/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 1236 | EUCTR2005-004314-33-HU (EUCTR) | 01/03/2006 | 20/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1237 | EUCTR2005-004314-33-GB (EUCTR) | 01/03/2006 | 29/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1238 | NCT00305331 (ClinicalTrials.gov) | March 2006 | 20/3/2006 | Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease | Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease | Parkinson's Disease;Peripheral Edema | Drug: Domperidone (drug) | University Health Network, Toronto | NULL | Terminated | 30 Years | 90 Years | Both | 25 | Phase 2 | Canada |
| 1239 | NCT00282152 (ClinicalTrials.gov) | March 2006 | 23/1/2006 | Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD) | Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease | Parkinson's Disease | Device: B-STN DBS;Drug: Optimal drug therapy | Vanderbilt University Medical Center | NULL | Completed | 50 Years | 75 Years | All | 37 | N/A | United States |
| 1240 | EUCTR2005-001032-72-CZ (EUCTR) | 16/02/2006 | 12/01/2006 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Trade Name: Stalevo 100 mg/25 mg / 200 mg Product Code: ELC200 Trade Name: SINEMET CR Product Name: SINEMET CR | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | ||||
| 1241 | EUCTR2005-004314-33-SE (EUCTR) | 03/02/2006 | 13/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1242 | EUCTR2005-004290-19-GB (EUCTR) | 03/02/2006 | 09/01/2006 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Austria;Germany;United Kingdom | ||
| 1243 | EUCTR2005-004314-33-BE (EUCTR) | 02/02/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1244 | EUCTR2005-004314-33-CZ (EUCTR) | 01/02/2006 | 11/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1245 | EUCTR2005-004314-33-LT (EUCTR) | 01/02/2006 | 03/01/2006 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania | |||
| 1246 | NCT00286897 (ClinicalTrials.gov) | February 2006 | 3/2/2006 | The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Limited | NULL | Completed | 30 Years | N/A | Both | 702 | Phase 3 | Austria;Belgium;Czech Republic;Estonia;France;Germany;Hungary;Israel;Italy;Lithuania;Poland;Portugal;Serbia;South Africa;Spain;Sweden;United Kingdom;Former Serbia and Montenegro |
| 1247 | NCT00296192 (ClinicalTrials.gov) | February 2006 | 22/2/2006 | Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms | A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of OFF Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease | Parkinson's Disease | Drug: Rotigotine nasal spray;Other: Placebo | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 82 | Phase 2 | Germany |
| 1248 | EUCTR2005-004314-33-IT (EUCTR) | 31/01/2006 | 07/09/2007 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND | Parkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 900 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1249 | EUCTR2005-004290-19-DE (EUCTR) | 25/01/2006 | 05/12/2005 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Spain | |||
| 1250 | NCT03095105 (ClinicalTrials.gov) | January 24, 2006 | 23/3/2017 | Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young Subjects | An Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol) | Parkinson Disease | Drug: 200 mg BIA 6-512 | Bial - Portela C S.A. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 1 | Germany |
| 1251 | EUCTR2005-004314-33-EE (EUCTR) | 17/01/2006 | 24/11/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden | |||
| 1252 | NCT00275275 (ClinicalTrials.gov) | January 2006 | 9/1/2006 | Pramipexole Conversion to Ropinirole Controlled Release (CR) | An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease. | Parkinson Disease | Drug: Requip PR;Drug: Mirapex | Rajesh Pahwa, MD | GlaxoSmithKline | Completed | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 1253 | NCT00279825 (ClinicalTrials.gov) | January 2006 | 18/1/2006 | Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 16 | Phase 2 | United States |
| 1254 | NCT00273351 (ClinicalTrials.gov) | January 2006 | 4/1/2006 | Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-risk Families | Assessment of Pre-symptomatic and Symptomatic Patients With Parkinson Disease to Identify and Characterize Genetic and Phenotypic Biomarkers for Disease Onset and Progression. | Parkinson Disease;Parkinsonian Syndrome | Drug: [123I]B-CIT | Institute for Neurodegenerative Disorders | Department of Defense;Molecular NeuroImaging | Completed | 21 Years | N/A | Both | 62 | Phase 2 | United States |
| 1255 | NCT02772614 (ClinicalTrials.gov) | January 2006 | 12/5/2016 | Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites | An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral Administration | Parkinson's Disease | Drug: BIA 3-202 (200 mg) | Bial - Portela C S.A. | NULL | Completed | 40 Years | 55 Years | Male | 4 | Phase 1 | Switzerland |
| 1256 | NCT00292227 (ClinicalTrials.gov) | January 2006 | 14/2/2006 | Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease | Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial. | Parkinson's Disease | Drug: Rotigotine;Other: Placebo;Drug: Moxifloxacin infusion;Other: Placebo infusion | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 130 | Phase 1 | South Africa |
| 1257 | NCT01683292 (ClinicalTrials.gov) | January 2006 | 7/9/2012 | Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease | An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease | Parkinson's Disease | Drug: Inhaled VR040;Drug: Placebo for VR040 | South Glasgow University Hospitals NHS Trust | Vectura Limited | Completed | 30 Years | N/A | Both | 29 | Phase 2 | United Kingdom |
| 1258 | EUCTR2005-005120-13-GB (EUCTR) | 21/12/2005 | 02/11/2005 | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s disease | Product Name: Apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 1259 | EUCTR2005-001032-72-IT (EUCTR) | 25/11/2005 | 26/03/2007 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | Parkinson s Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: ENTACAPONE INN INN or Proposed INN: LEVODOPA INN INN or Proposed INN: CARBIDOPA INN Trade Name: Sinemet INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA ANIDRA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 1260 | EUCTR2005-002432-10-MT (EUCTR) | 25/11/2005 | 10/10/2005 | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease | Parkinson Disease late stage | Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride Product Name: SLV308 (mono) hydrochloride Product Code: SLV308 (mono) hydrochloride | Solvay Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 60 | Malta | |||
| 1261 | EUCTR2005-000444-84-GB (EUCTR) | 23/11/2005 | 13/09/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 1262 | EUCTR2005-002010-38-DE (EUCTR) | 21/11/2005 | 10/02/2006 | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study | Advanced Parkinson´s Disease | Product Name: Trivastal Product Code: S 90049 INN or Proposed INN: Piribedil | Institut de Recherches Internationales Servier (I.R.I.S.) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 1263 | EUCTR2005-001416-42-PT (EUCTR) | 07/11/2005 | 25/08/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Hungary;Portugal;Germany;United Kingdom;Spain;Italy | |||
| 1264 | NCT00256204 (ClinicalTrials.gov) | November 2005 | 16/11/2005 | A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease | A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | Parkinson's Disease | Drug: Rasagiline Mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | 80 Years | All | 1174 | Phase 3 | Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States |
| 1265 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 1266 | EUCTR2004-005234-39-IE (EUCTR) | 20/10/2005 | 16/08/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 1267 | NCT00134251 (ClinicalTrials.gov) | October 2005 | 22/8/2005 | Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease | Parkinson's Disease | Drug: SLV308 | Solvay Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | Phase 3 | Bulgaria;Malta;Serbia;Former Serbia and Montenegro | |
| 1268 | NCT00517842 (ClinicalTrials.gov) | October 2005 | 15/8/2007 | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's Disease | Parkinson Disease | Drug: ViNeuro | Hospital Authority, Hong Kong | Vigconic (International) Ltd. | Completed | 30 Years | N/A | Both | 160 | N/A | China |
| 1269 | NCT00239564 (ClinicalTrials.gov) | October 2005 | 13/10/2005 | Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 100 mg;Drug: IPX054 150 mg;Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: IPX054 300 mg | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 1/Phase 2 | United States |
| 1270 | EUCTR2005-001416-42-HU (EUCTR) | 27/09/2005 | 20/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | |||
| 1271 | EUCTR2004-005234-39-FI (EUCTR) | 22/09/2005 | 03/06/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 1272 | EUCTR2005-001416-42-GB (EUCTR) | 15/09/2005 | 13/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: Azilect Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: Rasagiline Product Code: TVP-1012 | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1273 | EUCTR2005-000444-84-FI (EUCTR) | 08/09/2005 | 26/07/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;United Kingdom;Spain;Italy | ||
| 1274 | EUCTR2005-001416-42-DE (EUCTR) | 01/09/2005 | 17/10/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;United Kingdom;Germany;Spain;Italy | |||
| 1275 | NCT00224263 (ClinicalTrials.gov) | September 2005 | 20/9/2005 | Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI | Parkinson's Disease | Drug: Lingzhi (Ganoderma) | Xuanwu Hospital, Beijing | NULL | Completed | 30 Years | 80 Years | Both | 360 | Phase 2 | China |
| 1276 | NCT00165789 (ClinicalTrials.gov) | September 2005 | 12/9/2005 | A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations | Parkinson's Disease | Drug: E2007 | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States |
| 1277 | EUCTR2005-001416-42-AT (EUCTR) | 24/08/2005 | 20/07/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | |||
| 1278 | EUCTR2004-005234-39-DK (EUCTR) | 04/08/2005 | 31/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 1279 | NCT00125567 (ClinicalTrials.gov) | August 2005 | 29/7/2005 | Stalevo in Early Wearing-Off Patients | Multicentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-Off | Idiopathic Parkinson's Disease | Drug: Stalevo (levodopa/carbidopa/entacapone);Drug: Levodopa/carbidopa | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 223 | Phase 4 | Denmark;Finland;Germany;Ireland;Sweden;United Kingdom |
| 1280 | NCT00134966 (ClinicalTrials.gov) | August 2005 | 23/8/2005 | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa | A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa | Parkinson's Disease | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Novartis | NULL | Completed | 30 Years | 80 Years | All | 493 | Phase 3 | United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic |
| 1281 | EUCTR2005-001416-42-ES (EUCTR) | 28/07/2005 | 28/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO | Parkinson's Disease MedDRA version: 7.1;Level: PT;Classification code 10061536 | Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate Trade Name: AZILECT Product Name: rasagiline tablets Product Code: TVP-1012 INN or Proposed INN: rasagiline Other descriptive name: rasagiline mesilate | Teva Pharmaceuticals Industries LtD | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom | ||
| 1282 | EUCTR2004-000835-27-ES (EUCTR) | 18/07/2005 | 23/05/2006 | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Early idiopathic Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.P.A | NULL | Not Recruiting | Female: yes Male: yes | 212 | Phase 3 | Spain;Italy | ||
| 1283 | EUCTR2005-004290-19-AT (EUCTR) | 17/07/2005 | 06/12/2005 | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease | advanced-stage, idiopathic Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536 | Product Name: Rotigotine Nasal Spray Product Code: ND1421 INN or Proposed INN: Rotigotine hydrochloride | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Spain;Austria;Germany;United Kingdom | |||
| 1284 | EUCTR2005-001416-42-IT (EUCTR) | 14/07/2005 | 21/06/2005 | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects | Neuroprotective early treatment of Parkinson's disease subjects MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: NA Other descriptive name: NA Product Name: rasagiline Product Code: TVP-1012 | TEVA | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Hungary;Germany;United Kingdom;Spain;Italy | ||||
| 1285 | EUCTR2005-000444-84-ES (EUCTR) | 12/07/2005 | 22/05/2006 | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O | Treatment- Associated Dyskinesia in Parkinson´s Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 1286 | NCT00143026 (ClinicalTrials.gov) | July 2005 | 31/8/2005 | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. | Parkinson's Disease | Drug: carbidopa, levodopa, entacapone | Novartis | NULL | Completed | 30 Years | N/A | All | 184 | Phase 4 | Australia;Philippines;Taiwan;Thailand |
| 1287 | EUCTR2005-000444-84-AT (EUCTR) | 22/06/2005 | 18/05/2005 | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Spain;Austria;Italy;United Kingdom | ||
| 1288 | EUCTR2005-004314-33-AT (EUCTR) | 16/06/2005 | 05/12/2005 | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations | Levodopa treated Parkinson's disease patients with motor fluctuations MedDRA version: 8.1;Classification code 10061536 | Product Name: MARS Product Code: E2007 Product Name: MARS Product Code: E2007 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 1289 | EUCTR2004-005234-39-SE (EUCTR) | 08/06/2005 | 02/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 1290 | NCT00642889 (ClinicalTrials.gov) | June 2005 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension) | A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. | Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 227 | Phase 3 | NULL |
| 1291 | NCT00252850 (ClinicalTrials.gov) | June 2005 | 11/11/2005 | Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease | A Phase I, Open-Label Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin[NTN] to Assess the Safety and Tolerability of Intrastriatal Delivery to Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Genetic: CERE-120: AAV2-NTN | Sangamo Therapeutics | Ceregene | Completed | 35 Years | 75 Years | All | 12 | Phase 1 | United States |
| 1292 | EUCTR2004-005234-39-GB (EUCTR) | 27/05/2005 | 22/03/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet | Orion Corporation, ORION PHARMA, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 1293 | EUCTR2004-002641-12-GB (EUCTR) | 16/05/2005 | 30/06/2005 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 1294 | NCT03093389 (ClinicalTrials.gov) | May 11, 2005 | 22/3/2017 | Tolerability and Steady-state Pharmacokinetics of BIA 6-512 | A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy Volunteers | Parkinson Disease | Drug: BIA 6-512;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 40 | Phase 1 | Portugal |
| 1295 | NCT00163085 (ClinicalTrials.gov) | May 2005 | 9/9/2005 | The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil) | Pfizer | NULL | Completed | 30 Years | 80 Years | Both | 12 | Phase 2 | United States |
| 1296 | NCT00199433 (ClinicalTrials.gov) | May 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients | A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's Disease | Parkinson's Disease;Movement Disorder Syndrome | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 160 | Phase 2 | United States |
| 1297 | EUCTR2004-002641-12-ES (EUCTR) | 25/04/2005 | 10/07/2006 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 1298 | EUCTR2004-000817-20-IT (EUCTR) | 06/04/2005 | 13/04/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: istradefylline Product Code: KW-6002 Other descriptive name: NA Trade Name: COMTAN 200* 60 CPR 200 MG Product Name: NA Product Code: NA INN or Proposed INN: Entacapone | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1299 | NCT00375778 (ClinicalTrials.gov) | April 2005 | 12/9/2006 | Parkinson's Disease Evaluated by PET and the Effect of Memantine | Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine | Parkinson's Disease | Drug: memantine (drug) | University of Aarhus | Lundbeck Foundation | Completed | 50 Years | 70 Years | Both | 12 | N/A | Denmark |
| 1300 | NCT00199355 (ClinicalTrials.gov) | April 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 75 | Phase 2 | Japan |
| 1301 | NCT00108667 (ClinicalTrials.gov) | April 2005 | 15/4/2005 | Talampanel to Treat Parkinson's Disease | AMPA Receptor Antagonist Treatment of Parkinson's Disease | Parkinson Disease | Drug: IV Levodopa;Drug: Talampanel | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 40 | Phase 2 | United States |
| 1302 | EUCTR2004-001593-10-GB (EUCTR) | 21/03/2005 | 25/08/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: SARIZOTAN Product Code: EMD128130 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 1303 | EUCTR2004-002598-21-GB (EUCTR) | 02/03/2005 | 07/07/2005 | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Idiopathic Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United Kingdom | ||
| 1304 | NCT02834507 (ClinicalTrials.gov) | March 2005 | 13/7/2016 | Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | A Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: Placebo;Drug: BIA 3-202;Drug: Comtan®;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | Both | 19 | Phase 2 | NULL |
| 1305 | EUCTR2004-002650-59-GB (EUCTR) | 03/02/2005 | 30/06/2005 | A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a | A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a | Idiopathic Parkinson's disease | Product Name: rotigotine Product Code: SPM 962 INN or Proposed INN: rotigotine | SCHWARZ BIOSCIENCES | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United Kingdom | ||
| 1306 | EUCTR2004-001594-25-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 1307 | EUCTR2004-000817-20-AT (EUCTR) | 02/02/2005 | 29/12/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Lithuania;Austria;Latvia;Italy | |||
| 1308 | NCT00505687 (ClinicalTrials.gov) | February 2005 | 20/7/2007 | An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease | A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 186 | Phase 3 | United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom |
| 1309 | EUCTR2004-002641-12-AT (EUCTR) | 21/01/2005 | 17/12/2004 | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease | Parkinson's disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Austria;Italy;United Kingdom | ||
| 1310 | NCT00219284 (ClinicalTrials.gov) | January 2005 | 30/6/2005 | Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease | A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off | Parkinson's Disease With End of Dose Wearing Off | Drug: Carbidopa/levodopa/entacapone | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 359 | Phase 4 | United States;Puerto Rico |
| 1311 | EUCTR2004-001594-25-FI (EUCTR) | 30/12/2004 | 26/10/2004 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Code: EMD128130 INN or Proposed INN: Sarizotan hydrochloride | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain | ||
| 1312 | EUCTR2004-002598-21-AT (EUCTR) | 22/12/2004 | 17/11/2004 | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United Kingdom | ||
| 1313 | EUCTR2004-002609-66-IT (EUCTR) | 21/12/2004 | 03/03/2006 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 1314 | EUCTR2004-000817-20-ES (EUCTR) | 10/12/2004 | 04/05/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtan Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1315 | EUCTR2004-002609-66-DE (EUCTR) | 06/12/2004 | 22/04/2005 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 1316 | EUCTR2004-000835-27-IT (EUCTR) | 03/12/2004 | 21/07/2005 | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 1317 | EUCTR2004-000833-12-ES (EUCTR) | 02/12/2004 | 23/11/2004 | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. | Early idiopathic Parkinson’s disease MedDRA version: 7.0;Level: LLT;Classification code 10013113 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Safinamide | Newron Pharmaceuticals S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Spain;Italy | ||
| 1318 | EUCTR2004-000833-12-IT (EUCTR) | 02/12/2004 | 15/03/2005 | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: Monoamine oxidase B inhibitors | NEWRON PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain;Italy | |||
| 1319 | EUCTR2004-001593-10-IT (EUCTR) | 02/12/2004 | 03/01/2005 | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan hydrochloride Product Code: EMD 128130 INN or Proposed INN: Sarizotan hydrochloride | MERCK S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom;Italy | |||
| 1320 | EUCTR2004-000185-12-IT (EUCTR) | 02/12/2004 | 27/06/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1321 | NCT00243945 (ClinicalTrials.gov) | December 2004 | 24/10/2005 | A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease | A Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's Disease | IDIOPATHIC PARKINSON'S DISEASE | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 58 | Phase 3 | Germany |
| 1322 | NCT00242008 (ClinicalTrials.gov) | December 2004 | 18/10/2005 | A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease | A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | United States | |
| 1323 | NCT00643045 (ClinicalTrials.gov) | December 2004 | 21/3/2008 | Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist | Idiopathic Parkinson's Disease | Drug: Safinamide;Drug: Placebo | Newron | NULL | Completed | 30 Years | 80 Years | Both | 269 | Phase 3 | NULL |
| 1324 | EUCTR2004-000185-12-AT (EUCTR) | 25/11/2004 | 21/10/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;Austria;Italy;United Kingdom;Sweden | |||
| 1325 | EUCTR2004-001594-25-ES (EUCTR) | 24/11/2004 | 02/11/2004 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 | Treatment-Associated Dyskinesia in Parkinson's Disease | Product Name: Sarizotan Product Code: EMD 128130 INN or Proposed INN: Sarizotan Hydrochloride | MERCK KGaA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Austria | ||
| 1326 | EUCTR2004-000185-12-SE (EUCTR) | 11/11/2004 | 03/09/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1327 | EUCTR2004-000817-20-GB (EUCTR) | 08/11/2004 | 11/02/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | ||
| 1328 | NCT03091868 (ClinicalTrials.gov) | November 3, 2004 | 21/3/2017 | Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | Portugal |
| 1329 | NCT00296946 (ClinicalTrials.gov) | November 2004 | 23/2/2006 | Ipratropium Spray for Drooling Saliva in Parkinson's Disease | Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ipratropium bromide (drug) | University Health Network, Toronto | Parkinson's Disease Foundation | Completed | 30 Years | N/A | All | 20 | Phase 2 | Canada |
| 1330 | NCT00199394 (ClinicalTrials.gov) | November 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin UK, Ltd. | NULL | Completed | 30 Years | N/A | Both | 405 | Phase 3 | United Kingdom |
| 1331 | NCT00243971 (ClinicalTrials.gov) | November 2004 | 24/10/2005 | A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | A Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: SPM 962 | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | Germany | |
| 1332 | NCT01634360 (ClinicalTrials.gov) | November 2004 | 3/7/2012 | Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations | A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period Dyskinesias | Parkinson's Disease | Drug: Perampanel | Eisai Inc. | NULL | Terminated | N/A | N/A | All | 185 | Phase 2 | NULL |
| 1333 | EUCTR2004-000817-20-LV (EUCTR) | 22/10/2004 | 27/10/2004 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1334 | EUCTR2004-000361-35-IT (EUCTR) | 22/10/2004 | 23/05/2005 | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. | Parkinson's disease. MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: NA Product Code: E2007 Other descriptive name: NA | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Italy | ||||
| 1335 | EUCTR2004-000361-35-CZ (EUCTR) | 18/10/2004 | 22/10/2004 | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. | Parkinson's Disease | Product Name: MARS Product Code: E2007 Other descriptive name: MARS Other descriptive name: MARS Other descriptive name: MARS | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 225 | Czech Republic;Italy | |||
| 1336 | EUCTR2004-000148-26-ES (EUCTR) | 13/10/2004 | 16/09/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
| 1337 | EUCTR2004-000148-26-CZ (EUCTR) | 12/10/2004 | 11/10/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1338 | NCT00105508 (ClinicalTrials.gov) | September 30, 2004 | 15/3/2005 | Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan;Drug: Placebo | EMD Serono | NULL | Completed | 30 Years | N/A | All | 506 | Phase 3 | United States |
| 1339 | EUCTR2004-000148-26-SE (EUCTR) | 29/09/2004 | 05/07/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1340 | EUCTR2004-000185-12-FI (EUCTR) | 21/09/2004 | 23/07/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 1341 | EUCTR2004-000817-20-LT (EUCTR) | 16/09/2004 | 07/01/2005 | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. | Parkinson's Disease | Product Name: Istradefylline Product Code: KW-6002 INN or Proposed INN: Istradefylline Trade Name: Comtess Product Name: Comtess INN or Proposed INN: Entacapone | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 405 | Spain;Italy;Latvia;Lithuania | |||
| 1342 | EUCTR2004-003355-39-AT (EUCTR) | 14/09/2004 | 08/10/2004 | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. | Dementia associated with Parkinson's disease | Trade Name: Aricept 5 mg-Filmtabletten Product Name: Aricept 5mg-Filmtabletten | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 468 | Austria | |||
| 1343 | NCT00105521 (ClinicalTrials.gov) | September 2004 | 15/3/2005 | Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated Dyskinesia | A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HC1 | EMD Serono | NULL | Completed | 30 Years | N/A | All | 594 | Phase 3 | United States |
| 1344 | NCT00099268 (ClinicalTrials.gov) | September 2004 | 10/12/2004 | Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis Pharmaceuticals | Orion Corporation, Orion Pharma | Completed | 30 Years | 70 Years | All | 747 | Phase 3 | United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 1345 | NCT00641186 (ClinicalTrials.gov) | September 2004 | 18/3/2008 | Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) | A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: sodium oxybate | Baylor College of Medicine | Jazz Pharmaceuticals | Completed | 30 Years | 75 Years | All | 30 | Phase 2 | NULL |
| 1346 | NCT00296959 (ClinicalTrials.gov) | September 2004 | 23/2/2006 | Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease | Anti-Dyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients With Parkinson's Disease and Levodopa-Induced Dyskinesias | Parkinson's Disease | Drug: topiramate (drug) | University Health Network, Toronto | NULL | Terminated | 30 Years | 75 Years | Both | 20 | Phase 2 | Canada |
| 1347 | NCT00089622 (ClinicalTrials.gov) | August 4, 2004 | 6/8/2004 | Lisuride Patch to Treat Parkinson's Disease | Transcutaneous Lisuride Therapy of Parkinson's Disease | Parkinson Disease | Drug: Intravenous Levodopa;Drug: Lisuride Transdermal System | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 40 Years | 80 Years | All | 40 | Phase 2 | United States |
| 1348 | NCT00501969 (ClinicalTrials.gov) | August 2004 | 16/7/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa | Advanced Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 395 | Phase 3 | Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom |
| 1349 | EUCTR2004-000148-26-FI (EUCTR) | 30/07/2004 | 28/06/2004 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Italy;Sweden | ||
| 1350 | NCT00199420 (ClinicalTrials.gov) | July 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 580 | Phase 3 | United States |
| 1351 | NCT00086294 (ClinicalTrials.gov) | June 25, 2004 | 29/6/2004 | ACP-103 to Treat Parkinson's Disease | 5HT2A/C Serotonin Blockade in Parkinson's Disease | Parkinson's Disease;Dyskinesias | Drug: Intravenous Levodopa;Drug: ACP-103 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 30 Years | 80 Years | All | 40 | Phase 2 | United States |
| 1352 | EUCTR2004-000148-26-IT (EUCTR) | 14/06/2004 | 26/07/2007 | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa | Advanced stage Parkinson's Disease | INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Hungary;Finland;Czech Republic;Spain;Italy;Sweden | ||
| 1353 | NCT00199407 (ClinicalTrials.gov) | June 2004 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | A 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 230 | Phase 3 | United States |
| 1354 | NCT00203138 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's Disease | A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | 35 Years | N/A | Both | 306 | Phase 3 | United States |
| 1355 | NCT03091543 (ClinicalTrials.gov) | May 4, 2004 | 21/3/2017 | Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg | Parkinson Disease | Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Portugal |
| 1356 | NCT01172379 (ClinicalTrials.gov) | May 2004 | 26/7/2010 | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period Dyskinesias | Parkinson's Disease | Drug: E2007;Other: Placebo Comparator | Eisai Limited | NULL | Completed | 30 Years | 75 Years | Both | 2 | Phase 2 | Czech Republic;France;Germany;Italy;Serbia;Spain |
| 1357 | NCT02231905 (ClinicalTrials.gov) | January 2004 | 3/9/2014 | Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease | Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole | Parkinson Disease | Drug: BI-Sifrol® | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 29 | Phase 4 | NULL |
| 1358 | NCT00139867 (ClinicalTrials.gov) | January 2004 | 29/8/2005 | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | Parkinson's Disease | Drug: PARCOPA | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | United States | |
| 1359 | NCT00111982 (ClinicalTrials.gov) | December 2003 | 27/5/2005 | Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin | Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168) | Parkinson's Disease | Biological: Liatermin | Amgen | Medtronic | Completed | 35 Years | 70 Years | Both | 34 | Phase 1/Phase 2 | United States |
| 1360 | NCT00363727 (ClinicalTrials.gov) | December 2003 | 7/8/2006 | Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's | A Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects. | Parkinson's Disease;Parkinson Disease;Dyskinesias | Drug: ropinirole controlled-release (REQUIP CR) for RLS | GlaxoSmithKline | NULL | Completed | 30 Years | 70 Years | All | 209 | Phase 3 | United States |
| 1361 | NCT01941732 (ClinicalTrials.gov) | November 2003 | 10/9/2013 | Motor Response to Sildenafil in PD | Motor Response to Acute Challenge to Sildenafil in Parkinsons Disease | Parkinsons Disease;Erectile Dysfunction | Drug: Sildenafil | Bispebjerg Hospital | NULL | Completed | 18 Years | 80 Years | Male | 8 | Phase 4 | Denmark |
| 1362 | NCT00234676 (ClinicalTrials.gov) | October 2003 | 5/10/2005 | POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease | A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease | Parkinson's Disease | Drug: Premarin ® | The Parkinson Study Group | Wyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman Foundation | Completed | N/A | 75 Years | Female | 23 | Phase 2 | United States |
| 1363 | NCT00160576 (ClinicalTrials.gov) | July 2003 | 8/9/2005 | Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias | A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease | Idiopathic Parkinson Disease | Drug: Levetiracetam | UCB Pharma | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | NULL |
| 1364 | NCT00228150 (ClinicalTrials.gov) | July 2003 | 26/9/2005 | Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease | A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease | Parkinson Disease | Drug: SR57667B | Sanofi | NULL | Completed | 35 Years | N/A | Both | 564 | Phase 2 | Austria;Canada;Denmark;France;Germany;Morocco;Netherlands;Portugal;South Africa;Spain;Sweden;Tunisia;United Kingdom |
| 1365 | NCT00095810 (ClinicalTrials.gov) | July 2003 | 9/11/2004 | Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease | An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease | Parkinson's Disease;Psychoses | Drug: aripiprazole | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka America Pharmaceutical | Completed | 50 Years | N/A | Both | 50 | Phase 4 | United States |
| 1366 | NCT00058721 (ClinicalTrials.gov) | April 2003 | 11/4/2003 | Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease | SPECT Evaluation of Nicotinic Cholinergic Receptors in Parkinson's Disease | Parkinson Disease | Drug: I-123-5-IA85380 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 60 | N/A | United States |
| 1367 | NCT01327859 (ClinicalTrials.gov) | March 2003 | 30/3/2011 | Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With Dementia | A 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With Dementia | Parkinson's Disease;Dementia | Drug: Prior Donepezil 5mg;Drug: Prior Donzepezil 10mg;Drug: Prior Placebo | Eisai Inc. | NULL | Completed | 40 Years | N/A | Both | 357 | Phase 3 | United Kingdom |
| 1368 | NCT00115427 (ClinicalTrials.gov) | March 2003 | 22/6/2005 | Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease | Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: Liatermin (r-metHuGDNF) | Amgen | NULL | Completed | 35 Years | 70 Years | Both | Phase 1 | United States | |
| 1369 | NCT00237263 (ClinicalTrials.gov) | February 2003 | 7/10/2005 | An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United States | An Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off | Parkinson's Disease | Drug: Entacapone | Novartis | NULL | Completed | 20 Years | N/A | All | 285 | Phase 2 | United States |
| 1370 | NCT00056524 (ClinicalTrials.gov) | February 2003 | 15/3/2003 | Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter) | An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect. | Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain Injury | Drug: AVP-923 | Avanir Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | Both | 600 | Phase 3 | United States |
| 1371 | NCT02248207 (ClinicalTrials.gov) | January 2003 | 22/9/2014 | Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease | Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 1293 | N/A | NULL |
| 1372 | NCT00206687 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | STEPS Trial - Spheramine Safety and Efficacy Study | Study of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's Disease | Parkinson Disease | Biological: Spheramine (BAY86-5280);Procedure: Placebo | Bayer | Titan Pharmaceuticals | Terminated | 30 Years | 70 Years | Both | 71 | Phase 2 | United States;Germany;Spain;Austria;France |
| 1373 | NCT00247247 (ClinicalTrials.gov) | December 2002 | 31/10/2005 | Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off. | Efficacy and Tolerability of Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing-Off Phenomenon | Parkinson's Disease | Drug: Comtess® | Orion Corporation, Orion Pharma | NULL | Completed | 60 Years | N/A | Both | 300 | Phase 4 | Germany |
| 1374 | NCT00209508 (ClinicalTrials.gov) | November 2002 | 13/9/2005 | 2 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PD | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy. | Parkinson's Disease | Drug: GPI 1485 | Eisai Inc. | Symphony Neuro Development Company | Completed | 40 Years | 80 Years | Both | 200 | Phase 2 | NULL |
| 1375 | NCT00165815 (ClinicalTrials.gov) | August 2002 | 13/9/2005 | The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia | Dementia With Parkinson's Disease | Drug: ARICEPT | Eisai Limited | NULL | Completed | 40 Years | N/A | Both | Phase 3 | Germany;Ireland | ||
| 1376 | NCT00594386 (ClinicalTrials.gov) | August 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease. | Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 258 | Phase 3 | United States;Canada |
| 1377 | NCT00599196 (ClinicalTrials.gov) | August 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease | An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom |
| 1378 | NCT00314288 (ClinicalTrials.gov) | July 2002 | 12/4/2006 | Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia | Parkinson's Disease;Dyskinesia | Drug: Sarizotan HCl | EMD Serono | NULL | Completed | 30 Years | N/A | All | 360 | Phase 2 | United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Portugal;Romania;South Africa;United Kingdom |
| 1379 | NCT00040209 (ClinicalTrials.gov) | June 2002 | 21/6/2002 | JP-1730 to Treat Parkinson's Disease | Alpha-2 Adrenergic Antagonist Treatment of Parkinson's Disease | Parkinson Disease | Drug: JP 1730;Drug: IV Levodopa;Drug: IV Apomorphine | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 30 | Phase 2 | United States |
| 1380 | NCT00594165 (ClinicalTrials.gov) | June 2002 | 24/12/2007 | An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. | An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease. | Early-Stage Parkinson's Disease | Drug: Rotigotine | UCB Pharma | NULL | Completed | 31 Years | N/A | All | 217 | Phase 3 | United States;Canada |
| 1381 | NCT00203164 (ClinicalTrials.gov) | May 2002 | 13/9/2005 | Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease Patients | A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: rasagiline mesylate | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 254 | Phase 3 | United States |
| 1382 | NCT01044992 (ClinicalTrials.gov) | May 2002 | 6/1/2010 | Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study | Motor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic Challenge | Multisystemic Atrophy | Radiation: H215O PET;Drug: Levodopa | University Hospital, Toulouse | NULL | Completed | 40 Years | 75 Years | Both | 38 | N/A | France |
| 1383 | NCT00650104 (ClinicalTrials.gov) | May 2002 | 27/3/2008 | Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 | 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164 | Parkinson Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 76 | Phase 3 | United States;Belgium;France;Netherlands;Norway |
| 1384 | NCT00024622 (ClinicalTrials.gov) | March 15, 2002 | 23/9/2001 | PET Scanning in Parkinson s Disease | Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia | Schizophrenia;Parkinson's Disease | Drug: 18F-Fluoro-L-dopa;Drug: O-15 Water | National Institute of Mental Health (NIMH) | NULL | Recruiting | 18 Years | 90 Years | All | 580 | United States | |
| 1385 | NCT00040404 (ClinicalTrials.gov) | March 2002 | 26/6/2002 | Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's Disease | Parkinson Disease | Drug: CEP-1347 10mg;Drug: CEP1347 25mg;Drug: CEP-1347 50mg;Other: Placebo Comparator | Cephalon | H. Lundbeck A/S;The Parkinson Study Group | Terminated | 30 Years | N/A | Both | 806 | Phase 2/Phase 3 | United States;Canada;Puerto Rico |
| 1386 | NCT00030979 (ClinicalTrials.gov) | February 2002 | 15/2/2002 | Donepezil to Treat Dementia in Parkinson's Disease | Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial | Parkinson Disease | Drug: Donepezil | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 28 | Phase 4 | United States |
| 1387 | NCT00407212 (ClinicalTrials.gov) | January 2002 | 30/11/2006 | A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease | Parkinson's Disease | Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt) | Novartis | NULL | Completed | 30 Years | 80 Years | Both | 301 | Phase 1/Phase 2 | United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom |
| 1388 | NCT00036218 (ClinicalTrials.gov) | December 2001 | 8/5/2002 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease. | A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole;Drug: ropinirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 600 | Phase 3 | United States;Argentina;Mexico;Puerto Rico |
| 1389 | NCT00203177 (ClinicalTrials.gov) | October 2001 | 13/9/2005 | Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy. | A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy. | Parkinson's Disease | Drug: rasagiline mesylate;Drug: rasagiline mesylate 1.0 mg | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 254 | Phase 3 | United States;Canada |
| 1390 | NCT02772627 (ClinicalTrials.gov) | September 2001 | 12/5/2016 | Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers. | Parkinson's Disease | Drug: Nebicapone;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 22 | Phase 1 | Portugal |
| 1391 | NCT00013624 (ClinicalTrials.gov) | March 2001 | 24/3/2001 | Riluzole to Treat Parkinson's Disease | Effect of Antiglutamatergic Treatment in Parkinson's Disease | Parkinson's Disease | Drug: IV Levodopa | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |
| 1392 | NCT00145171 (ClinicalTrials.gov) | February 2001 | 2/9/2005 | A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 3 | NULL |
| 1393 | NCT00203125 (ClinicalTrials.gov) | October 2000 | 13/9/2005 | A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study. | Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133) | Parkinson's Disease | Drug: rasagiline mesylate;Other: tyramine | Teva Pharmaceutical Industries | NULL | Completed | N/A | N/A | Both | 55 | Phase 3 | United States |
| 1394 | NCT00006337 (ClinicalTrials.gov) | October 2000 | 4/10/2000 | KW-6002 to Treat Parkinson's Disease | Adenosine A2A Blockade With KW-6002 in Parkinson's Disease | Parkinson's Disease | Drug: KW-6002;Drug: IV Levodopa | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 16 | Phase 2 | United States |
| 1395 | NCT00070928 (ClinicalTrials.gov) | September 2000 | 9/10/2003 | Valerian to Improve Sleep in Patients With Parkinson's Disease | Polysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's Disease | Insomnia;Parkinson's Disease | Drug: valerian | National Center for Complementary and Integrative Health (NCCIH) | NULL | Completed | 30 Years | 80 Years | Both | 80 | Phase 2 | United States |
| 1396 | NCT02763800 (ClinicalTrials.gov) | September 2000 | 4/5/2016 | Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202 | Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 35 Years | Male | 33 | Phase 1 | United Kingdom |
| 1397 | NCT00036205 (ClinicalTrials.gov) | August 2000 | 8/5/2002 | Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease | Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Terminated | 30 Years | N/A | Both | 984 | Phase 3 | United States;Argentina;Colombia;Puerto Rico |
| 1398 | NCT00203034 (ClinicalTrials.gov) | May 2000 | 13/9/2005 | Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations | A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: rasagiline mesylate;Drug: 1.0 mg rasagiline mesylate;Other: Placebo | Teva Pharmaceutical Industries | NULL | Completed | 30 Years | N/A | Both | 472 | Phase 3 | United States |
| 1399 | NCT02763787 (ClinicalTrials.gov) | April 2000 | 4/5/2016 | Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202 | A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers. | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 35 Years | Male | 71 | Phase 1 | United Kingdom |
| 1400 | NCT00761436 (ClinicalTrials.gov) | February 29, 2000 | 26/9/2008 | Pilot Study of Safety and Efficacy of Spheramine | Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy. | Parkinson''s Disease | Biological: Spheramine (BAY86-5280) | Bayer | Titan Pharmaceuticals | Terminated | 40 Years | 70 Years | All | 6 | Phase 2 | United States |
| 1401 | NCT02172573 (ClinicalTrials.gov) | April 1999 | 20/6/2014 | Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease | A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine;Drug: Placebo pramipexole;Drug: Placebo bromocriptine | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 315 | Phase 3 | NULL |
| 1402 | NCT02177357 (ClinicalTrials.gov) | November 1998 | 24/6/2014 | Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients | Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | Both | 150 | Phase 3 | NULL |
| 1403 | NCT02248220 (ClinicalTrials.gov) | October 1998 | 22/9/2014 | Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease | Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease | Parkinson Disease | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 657 | N/A | NULL |
| 1404 | NCT02233023 (ClinicalTrials.gov) | June 1998 | 4/9/2014 | Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine and other dopamine agonists | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 705 | Phase 4 | NULL |
| 1405 | NCT00203060 (ClinicalTrials.gov) | July 1997 | 13/9/2005 | Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa | A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa | Parkinson's Disease | Drug: Rasagiline Mesylate;Drug: placebo | Teva Neuroscience, Inc. | NULL | Completed | 35 Years | N/A | Both | 404 | Phase 3 | United States |
| 1406 | NCT00001258 (ClinicalTrials.gov) | November 26, 1993 | 3/11/1999 | Studies of Frontal Lobe Brain Functioning in Schizophrenia | Studies of Frontal Lobe Function During Cognitive Stimulation as Measured With Oxygen-15 Water Positron Emission Tomography in Normal Subjects and Patients With Neuropsychiatric Disorders | Healthy Subjects;Schizophrenia;Parkinson Disease | Drug: Oxygen-15 Water | National Institute of Mental Health (NIMH) | NULL | Completed | 18 Years | 90 Years | All | 1039 | United States | |
| 1407 | EUCTR2006-006907-35-DE (EUCTR) | 30/01/2007 | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER | Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2mg/24h transdermal patch Product Code: ND1587 INN or Proposed INN: Rotigotine Trade Name: Neupro 4mg/24h transdermal patch Product Code: ND1589 INN or Proposed INN: Rotigotine Trade Name: Neupro 6mg/24h transdermal patch Product Code: ND1590 INN or Proposed INN: Rotigotine Trade Name: Neupro 8mg/24h transdermal patch Product Code: ND1702 INN or Proposed INN: Rotigotine | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | |||
| 1408 | JPRN-JapicCTI-111699 | 22/11/2011 | Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects with Advanced Parkinson's Disease | Advanced Parkinson's disease | Intervention name : ABT-SLV187 Dosage And administration of the intervention : Usually 2-6 ml/hour (40-120 mg levodopa/hour), dose will be individually optimized for each subject based on the subject's symptoms Control intervention name : null | Abbott Japan Co., Ltd. | NULL | 30 | BOTH | 8 | Phase 2 | NULL | |||
| 1409 | EUCTR2010-022200-46-DE (EUCTR) | 13/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Latvia;Germany | ||||
| 1410 | EUCTR2009-014341-84-DE (EUCTR) | 07/10/2009 | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. | idiopathic Parkinson's disease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 2mg/24h(10cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 4mg/24h (20cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 6mg/24h (30cm2) INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch Product Name: Rotigotine transdermal patch 8mg/24h (40cm2) INN or Proposed INN: rotigotine | Schwarz Pharma Deutschland GmbH, UCB Group | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | |||||
| 1411 | EUCTR2006-001755-36-DE (EUCTR) | 15/08/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden | ||||
| 1412 | EUCTR2020-006067-28-BE (EUCTR) | 18/11/2021 | A study to investigate if CST-103 and CST-107 has an effect on the brain in patients with progressive disease of the nervous system. | A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 co-administered with CST-107 on the Central Nervous System in Subjects with Neurodegenerative Disorders - PD Effects of CST-103/CST-107 on CNS in Neurodegenerative Disorders | Patients with Parkinson’s Disease with REM sleep behaviour disorder, Mild Cognitive Impairment, Dementia with Lewy Bodies and Parkinson’s Disease Dementia. MedDRA version: 24.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10009846;Term: Cognitive impairment;Classification code 10067889;Term: Dementia with Lewy bodies;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Spiropent Product Name: Spiropent Product Code: CST-103 INN or Proposed INN: Clenbuterol Hydrochloride Product Name: Nadolol Product Code: CST-107 INN or Proposed INN: Nadolol | CuraSen Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Belgium;Australia;United Kingdom;New Zealand | |||
| 1413 | EUCTR2011-002073-30-DE (EUCTR) | 20/09/2011 | Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease | L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 Product Name: AFQ056 Product Code: AFQ056 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | France;United States;Hungary;Canada;Spain;Germany;Italy | ||||
| 1414 | EUCTR2008-005492-94-DE (EUCTR) | 11/08/2009 | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients | Idiopathic Parkinson's Disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide Product Name: Safinamide Product Code: NW-1015 INN or Proposed INN: safinamide | Newron Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 1285 | United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand |