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 | NCT05669170 (ClinicalTrials.gov) | January 2024 | 16/12/2022 | Methylphenidate for Apathy in Veterans With Parkinson's Disease | Evaluating Safety and Potential Benefit of Methylphenidate as a Symptomatic Treatment for Apathy in Veterans With Parkinson's Disease. | Parkinson Disease;Apathy | Behavioral: Psychosocial intervention;Drug: Methylphenidate | Ralph H. Johnson VA Medical Center | NULL | Not yet recruiting | 40 Years | N/A | All | 60 | Phase 2 | NULL |
2 | NCT05721911 (ClinicalTrials.gov) | June 2023 | 30/1/2023 | Implementing a National Biobank of PD With WGS and Functional Assessment of Polygenic Inheritance by iPSC Technology | Implementing a National Biobank of Genetic, Sporadic and Prodromic Parkinson's Disease With Whole Genome Analysis and Functional Assessment of Polygenic Inheritance by iPSC Technology | Parkinson Disease;REM Sleep Behavior Disorder | Genetic: whole genome sequencing | Neuromed IRCCS | NULL | Not yet recruiting | 18 Years | N/A | All | 230 | Italy | |
3 | NCT05709301 (ClinicalTrials.gov) | April 1, 2023 | 11/1/2023 | Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Parkinson Disease;Mild Cognitive Impairment | Drug: Donepezil Hydrochloride;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Not yet recruiting | 50 Years | 80 Years | All | 120 | Phase 2 | NULL |
4 | NCT05634876 (ClinicalTrials.gov) | April 2023 | 23/11/2022 | UB-312 in Patients With Synucleinopathies | A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies | Multiple System Atrophy;Parkinson Disease | Biological: UB-312 Injection;Biological: Placebo Injection | NYU Langone Health | NULL | Not yet recruiting | 40 Years | 75 Years | All | 8 | Phase 1/Phase 2 | United States |
5 | NCT05636852 (ClinicalTrials.gov) | March 31, 2023 | 1/11/2022 | Altropane Dose for Imaging Patients With Suspected Parkinson's Disease | An Open-label Multicenter Phase 2 Dose-evaluation Study of Altropane (123I) Injection for Striatal Dopamine Transporter Visualization Using SPECT Brain Imaging | Parkinson Disease;Movement Disorders | Drug: Altropane (123I) Injection | GE Healthcare | Labcorp Drug Development Inc | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 2 | NULL |
6 | 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 |
7 | 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 |
8 | NCT05469997 (ClinicalTrials.gov) | January 2023 | 15/6/2022 | Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome | Ketogenic Diet Interventions in Parkinson's Disease: Safeguarding the Gut Microbiome | Parkinson Disease | Behavioral: Mediterranean-Ketogenic Diet;Dietary Supplement: Mediterranean diet supplemented with medium-chain triglyceride oil | University of British Columbia | Weston Family Foundation | Not yet recruiting | 45 Years | 85 Years | All | 50 | N/A | NULL |
9 | NCT05435755 (ClinicalTrials.gov) | December 2, 2022 | 15/3/2022 | Precise Transplantation of hAESCs Into the Ventricle for Parkinson's Disease. | The Precise Transplantation of Human Amniotic Epithelial Stem Cells Into the Ventricle Through Surgical Robot in the Treatment of Parkinson's Disease. | Parkinson's Disease | Biological: hAESCs treatment;Biological: placebo (saline) | Shanghai East Hospital | Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | Not yet recruiting | 30 Years | 70 Years | All | 12 | Early Phase 1 | China |
10 | NCT05197439 (ClinicalTrials.gov) | December 1, 2022 | 5/1/2022 | Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease | Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial | Dexmedetomidine;Postoperative Delirium;Deep Brain Stimulation | Drug: Dexmedetomidine;Drug: 0.9% saline | Beijing Tiantan Hospital | NULL | Not yet recruiting | 60 Years | N/A | All | 192 | N/A | China |
11 | 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 |
12 | NCT05589766 (ClinicalTrials.gov) | November 28, 2022 | 13/10/2022 | N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease | N-DOSE: A Dose Optimization Trial of Nicotinamide Riboside in Parkinson's Disease | Parkinson Disease | Dietary Supplement: Nicotinamide Riboside;Other: Placebo | Haukeland University Hospital | NULL | Recruiting | 40 Months | 100 Years | All | 80 | N/A | Norway |
13 | NCT05568498 (ClinicalTrials.gov) | October 30, 2022 | 15/6/2022 | Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease | Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease | Parkinson Disease;Depression | Dietary Supplement: Probiotic;Dietary Supplement: Placebo | University of British Columbia | NULL | Not yet recruiting | 40 Years | 80 Years | All | 60 | Phase 2 | NULL |
14 | 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 |
15 | NCT05550714 (ClinicalTrials.gov) | October 15, 2022 | 20/9/2022 | Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease | Choice of Anesthesia in Microelectrode Recording Guided Deep Brain Stimulation for Parkinson's Disease (CHAMPION):A Randomized Controlled, Non-Inferiority Study | PD - Parkinson's Disease;Dexmedetomidine;Desflurane;Deep Brain Stimulation | Drug: general anesthesia;Drug: Conscious sedation | Beijing Tiantan Hospital | NULL | Recruiting | 50 Years | 80 Years | All | 188 | N/A | China |
16 | NCT04810104 (ClinicalTrials.gov) | October 2022 | 15/3/2021 | Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug | Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist Drug | Parkinson Disease;Mild Cognitive Impairment | Drug: AZD0328;Drug: Placebo | King's College London | Helse Stavanger HF;Michael J. Fox Foundation for Parkinson's Research;Parkinsons Org UK;AstraZeneca;Masaryk University;Norges Parkinsonforbund, Norway;University of Exeter;Stichting Lygature;Innovative Medicines Initiative | Withdrawn | 50 Years | 80 Years | All | 0 | Phase 2 | Norway |
17 | NCT05370079 (ClinicalTrials.gov) | September 16, 2022 | 6/5/2022 | Control Cohort CTRL COH | Control Cohort CTRL COH | Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis | Biological: Collection of biological sample (blood and/or CSF) | Hospices Civils de Lyon | NULL | Not yet recruiting | 18 Years | N/A | All | 350 | N/A | France |
18 | 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 |
19 | JPRN-jRCTs041220054 | 15/08/2022 | 15/08/2022 | The effects of prebiotics on Parkinson's disease patients with wearing-off | The effects of prebiotics on wearing-off and intestinal environment in patients with Parkinson's disease | Parkinson's disease patients with wearing-off over 20 years old | administration of kestose and inulin Dose / Usage) Kestose: 6 g (3 g in the morning, 3 g in the evening) / 2 times a day, orally Inulin: 6g (3g in the morning, 3g in the evening) / 2 times a day, orally Administration period) 8 weeks | Hirooka Yoshiki | Watanabe Hirohisa | Recruiting | >= 20age old | Not applicable | Both | 20 | Phase 1-2 | Japan |
20 | 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 |
21 | 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 |
22 | NCT05355064 (ClinicalTrials.gov) | May 2022 | 18/12/2021 | Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease | Efficacy of Oral Administration of Trehalose in Patients With Parkinson Disease in Both Idiopathic and Induced by LRRK2 Mutation | Parkinson Disease | Drug: Trehalose | Neuromed IRCCS | NULL | Not yet recruiting | 18 Years | 80 Years | All | 20 | Phase 4 | NULL |
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 | 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 |
25 | 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 | ||
26 | NCT04831281 (ClinicalTrials.gov) | January 20, 2022 | 1/4/2021 | ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial) | A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Parkinson Disease Dementia;Dementia With Lewy Bodies | Drug: ATH-1017;Drug: Placebo | Athira Pharma | NULL | Active, not recruiting | 40 Years | 85 Years | All | 28 | Phase 2 | United States |
27 | 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 |
28 | NCT05152394 (ClinicalTrials.gov) | January 2022 | 29/11/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Parkinson's Disease | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Parkinson's Disease | Parkinson Disease | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Not yet recruiting | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda |
29 | 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 |
30 | NCT03446807 (ClinicalTrials.gov) | December 2021 | 20/2/2018 | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism | Parkinson Disease;Multiple System Atrophy;Progressive Supranuclear Palsy | Drug: Droxidopa;Drug: Placebo Oral Tablet | Loma Linda University | H. Lundbeck A/S | Not yet recruiting | 50 Years | N/A | All | 32 | Phase 2 | United States |
31 | 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 |
32 | NCT04944017 (ClinicalTrials.gov) | November 23, 2021 | 22/6/2021 | Ketamine for the Treatment of Depression in Parkinson's Disease | Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) | Parkinson's Disease;Depression | Drug: Ketamine Infusion;Other: Placebo - Saline Infusion | Yale University | Fox (Michael J.) Foundation for Parkinson's Research | Recruiting | 40 Years | 80 Years | All | 56 | Phase 2 | United States |
33 | NCT05164783 (ClinicalTrials.gov) | November 23, 2021 | 28/10/2021 | Multicenter Implementation of E-monitoring in Parkinson's Disease | Multicenter Implementation of E-monitoring in Parkinson's Disease | Parkinson Disease | Combination Product: Sanacoach Parkinson (SCP) | Zuyderland Medisch Centrum | AbbVie | Recruiting | 30 Years | N/A | All | 450 | N/A | Netherlands |
34 | NCT05173701 (ClinicalTrials.gov) | November 22, 2021 | 8/11/2021 | Effects of Probiotics on Peripheral Immunity in Parkinson's Disease | Effects of Probiotics on Peripheral Immunity in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Probiotics;Dietary Supplement: Placebo | Franca Marino | Università degli Studi del Piemonte Orientale Amedeo Avogadro;Università degli Studi dell'Insubria | Enrolling by invitation | N/A | N/A | All | 88 | N/A | Italy |
35 | 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 |
36 | 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 |
37 | 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 |
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 | NCT05128175 (ClinicalTrials.gov) | October 29, 2021 | 27/10/2021 | Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions | An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 15 | Phase 1 | India |
40 | 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 |
41 | NCT05106504 (ClinicalTrials.gov) | September 2, 2021 | 16/10/2021 | Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease | Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease | Bladder, Overactive;Parkinson Disease | Drug: Medical Cannabis | Sheba Medical Center | NULL | Recruiting | 18 Years | 80 Years | All | 100 | Israel | |
42 | ChiCTR2200059544 | 2021-09-01 | 2022-05-04 | Nomogram for Prediction of Postoperative Delirium after Deep Brain Stimulation of Subthalamic Nucleus in Parkinson's Disease under General Anesthesia | Nomogram for Prediction of Postoperative Delirium after Deep Brain Stimulation of Subthalamic Nucleus in Parkinson's Disease under General Anesthesia | Parkinson's disease | Gold Standard:Clinical outcome;Index test:The clinical prediction model of delirium after deep brain stimulation of the subthalamic nucleus in Parkinson's disease under general anesthesia.; | First Affiliated Hospital of Sun Yat-sen University | NULL | Completed | 18 | 80 | Both | Target condition:240;Difficult condition:0 | China | |
43 | ChiCTR2100050538 | 2021-09-01 | 2021-08-28 | Clinical study of Ganoderma lucidum extract in the treatment of motor and non motor symptoms in patients with early PD | Clinical study of Ganoderma lucidum extract in the treatment of motor and non motor symptoms in patients with early PD | Parkinson's disease | Experimental group:Reishi Mushroom Extract Treatment;Control group:None; | Xuanwu Hospital of Capital Medical University | NULL | Recruiting | 18 | 80 | Both | Experimental group:30;Control group:30; | China | |
44 | EUCTR2021-000541-41-DE (EUCTR) | 09/06/2021 | 29/04/2021 | Joint European Research on active and emerging pandemics | European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct | 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 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 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 Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Oslo University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
45 | NCT04346394 (ClinicalTrials.gov) | May 11, 2021 | 10/3/2020 | The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease | The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor Symptoms | Parkinson Disease | Drug: Yohimbine HCl | Nathaniel M. Robbins | NULL | Suspended | N/A | N/A | All | 22 | Early Phase 1 | United States |
46 | 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 |
47 | 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 |
48 | EUCTR2021-000826-89-FR (EUCTR) | 23/04/2021 | 25/03/2021 | Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement | Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement | 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: APOKINON Product Name: APOKINON Product Code: N04BC07 | CHU Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 4 | France | ||
49 | 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 | ||
50 | 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 | ||
51 | 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 |
52 | NCT04322461 (ClinicalTrials.gov) | March 15, 2021 | 24/3/2020 | Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population | Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA | Parkinson Disease;Alzheimer Disease | Dietary Supplement: Betaquik MCT supplement | Université de Sherbrooke | Nestlé | Not yet recruiting | 60 Years | N/A | All | 20 | N/A | NULL |
53 | JPRN-jRCTs041190126 | 22/02/2021 | 10/03/2020 | Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease | Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi | Lewy body disease (Parkinson's disease and dementia with Lewy bodies) | Arm zonisamide: 1.Two tablets of zonisamide 25mg after breakfast for 4 weeks 2.Four tablets of zonisamide 25mg after breakfast for 92 weeks Arm placebo: 1.Two tablets of placebo after breakfast for 4 weeks 2.Four tablets of placebo after breakfast for 92 weeks | Katsuno Masahisa | Japan Agency for Medical Research and Development | Not Recruiting | >= 50age old | < 80age old | Both | 30 | Phase 2 | Japan |
54 | 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 |
55 | NCT04590612 (ClinicalTrials.gov) | January 2021 | 17/9/2020 | Improving Quality of Life in Early Parkinson's Disease | The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients | Parkinson Disease;Depression | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: Citalopram | Western University, Canada | NULL | Not yet recruiting | 50 Years | 80 Years | All | 30 | N/A | NULL |
56 | 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 |
57 | JPRN-jRCTs031200172 | 23/12/2020 | 26/10/2020 | Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation | Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD | Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation | Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment. | Hatano Taku | Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd. | Not Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
58 | 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 |
59 | 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 |
60 | NCT04620382 (ClinicalTrials.gov) | November 9, 2020 | 27/10/2020 | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients | Neurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease | Drug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compression | Vanderbilt University Medical Center | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 40 Years | 80 Years | All | 31 | Early Phase 1 | United States |
61 | NCT04506073 (ClinicalTrials.gov) | November 9, 2020 | 16/7/2020 | Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD | Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled Trial | Parkinson's Disease | Drug: MSC+placebo;Drug: MSC;Drug: Placebo | The University of Texas Health Science Center, Houston | Michael J. Fox Foundation for Parkinson's Research | Active, not recruiting | 50 Years | 79 Years | All | 45 | Phase 2 | United States |
62 | NCT04387773 (ClinicalTrials.gov) | November 5, 2020 | 11/5/2020 | Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease | Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease | Parkinson Disease | Drug: GOCOVRI | Oregon Health and Science University | Adamas Pharmaceuticals, Inc. | Completed | 50 Years | 80 Years | All | 8 | Phase 4 | United States |
63 | 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 |
64 | NCT04591535 (ClinicalTrials.gov) | September 28, 2020 | 11/9/2020 | PK Study of WD-1603 in Healthy Subjects | An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions | Parkinson Disease | Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
65 | NCT04553978 (ClinicalTrials.gov) | September 18, 2020 | 13/9/2020 | A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting Conditions | An Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting Conditions | Parkinson Disease | Drug: WD-1603 | Hong Kong WD Pharmaceutical Co., Limited | NULL | Not yet recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | NULL |
66 | NCT04513340 (ClinicalTrials.gov) | August 13, 2020 | 12/8/2020 | WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects | AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS | Parkinson Disease | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
67 | 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 |
68 | JPRN-UMIN000040889 | 2020/06/24 | 24/06/2020 | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease | Parkinson's disease | Levodopa-carbidopa continuous infusion gel (LCIG) therapy | Fujita Health University School of MedicineDepartment of Gastroenterology | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan |
69 | 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 |
70 | NCT03568968 (ClinicalTrials.gov) | May 15, 2020 | 14/6/2018 | A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease | A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK Study | Parkinson Disease | Dietary Supplement: Nicotinamide Riboside;Drug: Placebo | Haukeland University Hospital | NULL | Recruiting | 18 Years | N/A | All | 400 | N/A | Norway |
71 | 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 | |
72 | 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 | ||
73 | NCT04167540 (ClinicalTrials.gov) | April 1, 2020 | 7/11/2019 | GDNF Gene Therapy for Parkinson's Disease | Open-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's Disease | Parkinson's Disease | Biological: AAV2-GDNF | Brain Neurotherapy Bio, Inc. | Asklepios Biopharmaceutical, Inc.;California Institute for Regenerative Medicine (CIRM) | Active, not recruiting | 35 Years | 75 Years | All | 11 | Phase 1 | United States |
74 | 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 |
75 | 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 |
76 | 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 | ||
77 | NCT04260581 (ClinicalTrials.gov) | March 1, 2020 | 5/2/2020 | Is Long-term Use of Amantadine Effective in PD? | Is Long-term Use of Amantadine Effective in Parkinson Disease? | Parkinson Disease | Drug: Determination of drug effects through amantadine cessation | Seoul National University Hospital | NULL | Not yet recruiting | 40 Years | N/A | All | 32 | N/A | Korea, Republic of |
78 | 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 |
79 | NCT04228172 (ClinicalTrials.gov) | February 24, 2020 | 7/1/2020 | Genotypic Influences on Network Progression in Parkinson's Disease | Genotypic Influences on Network Progression in Parkinson's Disease | Parkinson's Disease | Genetic: DNA/GeneticTesting;Radiation: FDG PET scan;Other: MRI scan;Other: Clinical and neuropsychological assessments | Northwell Health | Michael J. Fox Foundation for Parkinson's Research;The Silverstein Foundation for Parkinson's with GBA | Recruiting | 40 Years | 75 Years | All | 32 | United States | |
80 | 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 |
81 | 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 | ||
82 | NCT04428983 (ClinicalTrials.gov) | February 3, 2020 | 20/11/2019 | The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease | The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's Disease | Parkinson Disease | Dietary Supplement: Hericium erinaceus mycelium | National Cheng-Kung University Hospital | NULL | Recruiting | 50 Years | 79 Years | All | 80 | N/A | Taiwan |
83 | EUCTR2018-003289-15-DE (EUCTR) | 28/01/2020 | 08/02/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | 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 Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany | ||
84 | NCT04305002 (ClinicalTrials.gov) | January 21, 2020 | 20/2/2020 | Exenatide Treatment in Parkinson's Disease | Effect of Exenatide on Disease Progression in Early Parkinson's Disease | Parkinson Disease | Drug: Exenatide;Drug: Placebo | Center for Neurology, Stockholm | Karolinska Institutet | Active, not recruiting | 25 Years | 80 Years | All | 60 | Phase 2 | Sweden |
85 | NCT04232969 (ClinicalTrials.gov) | January 20, 2020 | 10/1/2020 | Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | Parkinson's Disease | Drug: Exenatide extended release 2mg (Bydureon) | University College, London | NULL | Active, not recruiting | 25 Years | 80 Years | All | 194 | Phase 3 | United Kingdom |
86 | 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 | ||
87 | EUCTR2018-003289-15-PT (EUCTR) | 13/01/2020 | 21/08/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia 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 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | 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 | ||
88 | 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 |
89 | NCT04687878 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2020 | The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients | Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial | Parkinson Disease | Drug: Insulin;Drug: Normal saline | dr.dargahi | NULL | Recruiting | 17 Years | N/A | All | 40 | Phase 2 | Iran, Islamic Republic of |
90 | 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 | ||
91 | NCT04097080 (ClinicalTrials.gov) | December 15, 2019 | 18/9/2019 | Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease | Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's Disease | Parkinson Disease | Drug: NBTX-001;Drug: Standard of Care | Nobilis Therapeutics Inc. | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 1 | Russian Federation |
92 | 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 |
93 | NCT04768023 (ClinicalTrials.gov) | November 18, 2019 | 14/2/2021 | 12 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBS | Influence of 12 Weeks Vitamin D Supplementation Combined With Physical Activity on Blood and Functional Parameters and Quality of Life in Parkinson's Disease Patients Treated With Deep Brain Stimulation | Vitamin D Deficiency;Parkinson Disease | Drug: Juvit D3;Behavioral: steps per day;Drug: Placebo | Medical University of Gdansk | NULL | Enrolling by invitation | 40 Years | 90 Years | All | 72 | N/A | Poland |
94 | 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 |
95 | 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 |
96 | 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 |
97 | NCT03652870 (ClinicalTrials.gov) | October 31, 2019 | 8/8/2018 | Antidepressants Trial in Parkinson's Disease | A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease | Depression;Parkinson Disease | Drug: Nortriptyline;Drug: Escitalopram;Drug: Placebo | University College, London | London North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS Lothian | Recruiting | 18 Years | 85 Years | All | 408 | Phase 3 | United Kingdom |
98 | EUCTR2018-002942-35-GB (EUCTR) | 31/10/2019 | 05/09/2019 | A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s disease | A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease - Antidepressants Trial in Parkinson's Disease (ADepT-PD) | Depression in Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Escitalopram INN or Proposed INN: Escitalopram oxalate Trade Name: Nortriptyline Product Name: Nortriptyline INN or Proposed INN: Nortriptyline hydrochloride | University College London Comprehensive Clinical Trials Unit | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 408 | Phase 3 | United Kingdom | ||
99 | NCT04273932 (ClinicalTrials.gov) | October 17, 2019 | 31/10/2019 | Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease. | Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease. | Parkinson Disease | Drug: Lithium | State University of New York at Buffalo | NULL | Active, not recruiting | 45 Years | 80 Years | All | 19 | Phase 1 | United States |
100 | 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 | ||
101 | 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 | ||
102 | EUCTR2018-003289-15-BG (EUCTR) | 10/10/2019 | 24/07/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia 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 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | 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 | ||
103 | EUCTR2018-002234-21-DE (EUCTR) | 23/09/2019 | 16/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 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 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 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 Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
104 | 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 | ||
105 | EUCTR2018-003028-35-GB (EUCTR) | 04/09/2019 | 15/11/2019 | A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. | A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. - Phase 3 Trial of exenatide for Parkinson’s disease | 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: Bydureon Product Name: Bydureon INN or Proposed INN: Exenatide | University College London Comprehensive Clinical Trial Unit | NULL | Authorised-recruitment may be ongoing or finished | 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 Kingdom | ||
106 | 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 |
107 | 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 |
108 | 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 | ||
109 | EUCTR2018-002234-21-ES (EUCTR) | 21/08/2019 | 11/06/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuations | AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 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 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 Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
110 | 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 | ||
111 | 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 |
112 | 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 | ||
113 | 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 |
114 | 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 |
115 | 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 | ||
116 | EUCTR2018-003289-15-PL (EUCTR) | 19/07/2019 | 07/05/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | 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 chydrochloride Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
117 | 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 |
118 | 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 | ||
119 | 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 | ||
120 | NCT05146921 (ClinicalTrials.gov) | July 4, 2019 | 2/11/2021 | Gut Health and Probiotics in Parkinson's (SymPD) | Gut Health and Probiotics in Parkinson's (SymPD) | Parkinson Disease | Dietary Supplement: Multi-strain probiotic;Other: Placebo | King's College Hospital NHS Trust | King's College London | Active, not recruiting | 18 Years | N/A | All | 60 | N/A | United Kingdom |
121 | 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 | ||
122 | EUCTR2018-003289-15-DK (EUCTR) | 02/07/2019 | 14/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia 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 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand | ||
123 | 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 |
124 | NCT03977441 (ClinicalTrials.gov) | July 2019 | 12/5/2019 | the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease | A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression;Sleep Disorders;Circadian Rhythm Disorders | Drug: Agomelatine or PIacebo | Second Affiliated Hospital of Soochow University | NULL | Not yet recruiting | 30 Years | 75 Years | All | 240 | Phase 4 | NULL |
125 | EUCTR2018-003289-15-ES (EUCTR) | 26/06/2019 | 27/06/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | 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 Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 188 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany | ||
126 | 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 |
127 | EUCTR2018-003289-15-HU (EUCTR) | 04/06/2019 | 05/04/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | 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 Other descriptive name: TD-9855 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 3 | Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Denmark;Bulgaria;Germany | ||
128 | JPRN-UMIN000036952 | 2019/06/04 | 04/06/2019 | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others. | 18F-FDOPA, 11C-Raclopride PET | Nagoya City Rehabilitation Agency | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan |
129 | ChiCTR1900022534 | 2019-06-01 | 2019-04-15 | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial | non-motor symptoms of Parkinson’s disease | entacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.; | Geriatric Hospital of Hainan | NULL | Pending | 40 | 75 | Both | entacapone group:194;pramipexole group:194; | N/A | China |
130 | JPRN-UMIN000036908 | 2019/05/31 | 31/05/2019 | A dementia study by 11C-PiB, 18F-FDG PET | A dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET | mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc. | 11C-PiB, 18F-FDG PET | Nagoya City Rehabilitation Agency | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan |
131 | 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 |
132 | EUCTR2018-003289-15-AT (EUCTR) | 15/05/2019 | 22/03/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia 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 | 188 | Phase 3 | United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand | ||
133 | 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 |
134 | 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 |
135 | 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 | ||
136 | JPRN-jRCTs051180214 | 12/04/2019 | 27/03/2019 | The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease | The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease | Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy | Amyloid PET: Given the flutemetamol (3mL) intravenously FDG-PET:Given the FDG scanR (3mL) intravenously | Itoh Yoshiaki | NULL | Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
137 | EUCTR2018-003289-15-EE (EUCTR) | 11/04/2019 | 30/01/2019 | This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) | A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure | 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 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 188 | 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 | ||
138 | 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 | ||
139 | 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 | ||
140 | 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 | ||
141 | NCT03816020 (ClinicalTrials.gov) | March 9, 2019 | 7/12/2018 | NAD-supplementation in Drug naïve Parkinson's Disease | NAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's Disease | Parkinson Disease;Neurodegenerative Diseases | Dietary Supplement: Nicotinamide Riboside;Other: Placebo | Haukeland University Hospital | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Norway |
142 | EUCTR2017-005170-19-FI (EUCTR) | 06/03/2019 | 07/12/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | 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 | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
143 | 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 |
144 | NCT03829657 (ClinicalTrials.gov) | February 22, 2019 | 10/1/2019 | Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure | 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 | Symptomatic Neurogenic Orthostatic Hypotension;MSA;Parkinson's Disease (PD);Pure Autonomic Failure (PAF) | Drug: ampreloxetine;Drug: Placebo | Theravance Biopharma | NULL | Active, not recruiting | 30 Years | N/A | All | 203 | Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Canada;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;New Zealand;Poland;Portugal;Russian Federation;Spain;Ukraine;United Kingdom |
145 | 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 | ||
146 | NCT03466723 (ClinicalTrials.gov) | February 14, 2019 | 9/3/2018 | miRNAs Profiling in Parkinson's Disease | Novel and Minimal Invasive Biomarkers for Parkinson's Disease: Profiling of Serum Circulating miRNAs and Patho-physiological Implications | Parkinson Disease | Genetic: biomarker identification in Parkinson disease | Neuromed IRCCS | NULL | Active, not recruiting | 30 Years | N/A | All | 1000 | Italy | |
147 | NCT03815071 (ClinicalTrials.gov) | February 1, 2019 | 21/1/2019 | A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells | Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease | Parkinson Disease | Drug: Ips-nsc cells | Allife Medical Science and Technology Co., Ltd. | The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital;Henan Provincial People's Hospital;Beijing Hospital | Not yet recruiting | 18 Years | 60 Years | All | 10 | Early Phase 1 | NULL |
148 | 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 |
149 | 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 | ||
150 | 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 | ||
151 | EUCTR2018-002877-23-AT (EUCTR) | 21/01/2019 | 07/12/2018 | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD | Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD | Social functioning 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] | Trade Name: Syntocinon 40 IU/ml nasal spray INN or Proposed INN: Synthetic Oxytocin Other descriptive name: OXYTOCIN SYNTHETIC | Abteilung für Neurologie der Medizinischen Universität Innsbruck | NULL | Not Recruiting | Female: no Male: yes | 76 | Phase 2 | Austria | ||
152 | 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 |
153 | JPRN-UMIN000035602 | 2019/01/11 | 21/01/2019 | Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease | Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease - Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease | Parkinson's disease | hydrogen gas16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation placebo gas 16 weeks inhalation two times of the inhalation for 60 minutes per day 8 weeks obsebation after the inhalation | Juntendo University Koshigaya Hospital | NULL | Complete: follow-up complete | 40years-old | 80years-old | Male and Female | 20 | Not selected | Japan |
154 | NCT03659682 (ClinicalTrials.gov) | January 2, 2019 | 3/9/2018 | GLP1R in Parkinson's Disease | Effect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's Disease | Parkinson Disease | Drug: Semaglutide | Oslo University Hospital | NULL | Not yet recruiting | 40 Years | 75 Years | All | 120 | Phase 2 | NULL |
155 | NCT03727295 (ClinicalTrials.gov) | January 1, 2019 | 30/10/2018 | Idebenone Treatment of Early Parkinson's Diseasesymptoms | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor Symptoms | Oxidative Stress is an Important Cause of Parkinson's Disease | Drug: Idebenone/placebo | Second Affiliated Hospital of Soochow University | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | 80 Years | All | 180 | Phase 4 | NULL |
156 | 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 |
157 | 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 |
158 | 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 |
159 | 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 |
160 | 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 | ||
161 | 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 |
162 | 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 |
163 | 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 |
164 | NCT03727139 (ClinicalTrials.gov) | November 1, 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 | Drug: Rasagiline | Takeda | NULL | Completed | N/A | N/A | All | 1021 | Japan | |
165 | NCT03069911 (ClinicalTrials.gov) | November 1, 2018 | 28/2/2017 | Trial of OnabotulinumtoxinA for Depression in Parkinson Disease | Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease | Parkinson Disease;Depression | Biological: OnabotulinumtoxinA;Biological: Control | Johns Hopkins University | NULL | Terminated | 18 Years | 95 Years | All | 3 | Phase 1 | United States |
166 | 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 | ||
167 | 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 | ||
168 | 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 | ||
169 | 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 | ||
170 | 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 | ||
171 | NCT03229174 (ClinicalTrials.gov) | August 23, 2018 | 21/4/2017 | Brain Perfusion & Oxygenation in Parkinson's Disease With NOH | Evaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus Placebo | Parkinson Disease;Neurogenic Orthostatic Hypotension | Drug: Droxidopa;Drug: Placebo | William Ondo, MD | Lundbeck LLC | Completed | 18 Years | 85 Years | All | 17 | Phase 4 | United States |
172 | NCT03567447 (ClinicalTrials.gov) | August 17, 2018 | 21/5/2018 | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH) | Parkinson Disease;Falls Patient | Drug: Droxidopa;Other: Placebo | St. Joseph's Hospital and Medical Center, Phoenix | H. Lundbeck A/S;Arizona State University | Recruiting | 30 Years | 83 Years | All | 10 | Phase 2 | United States |
173 | NCT03675282 (ClinicalTrials.gov) | August 14, 2018 | 5/9/2018 | Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls | Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and Controls | Parkinson Disease;REM Sleep Behavior Disorder;Healthy | Drug: (11C)PE2I;Drug: Ioflupane | Weill Medical College of Cornell University | National Institute of Neurological Disorders and Stroke (NINDS) | Active, not recruiting | 20 Years | 100 Years | All | 82 | Phase 1/Phase 2 | United States |
174 | 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 | ||
175 | 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 |
176 | JPRN-UMIN000033285 | 2018/08/01 | 05/07/2018 | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease | Parkinson's disease | Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks | Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital | Department of Neurology, Nishi-Niigata Chuo Hospital | Pending | 50years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
177 | EUCTR2017-005170-19-SE (EUCTR) | 30/07/2018 | 10/04/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | 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 | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
178 | 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 |
179 | 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 |
180 | 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 | ||
181 | NCT03521635 (ClinicalTrials.gov) | July 3, 2018 | 11/4/2018 | The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa | A Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole SR;Drug: Pramipexole IR | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 98 | Phase 4 | China |
182 | 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 |
183 | 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 |
184 | 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 | ||
185 | 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 |
186 | 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 | ||
187 | NCT03684122 (ClinicalTrials.gov) | June 1, 2018 | 23/9/2018 | Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD). | A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD). | Parkinson Disease | Biological: Injection of Umbilical cord derived MSCs | University of Jordan | NULL | Active, not recruiting | 20 Years | 75 Years | All | 10 | Phase 1/Phase 2 | Jordan |
188 | 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 | ||
189 | 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 | ||
190 | 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 | ||
191 | 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 | ||
192 | 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 | ||
193 | 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 | ||
194 | 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 | ||
195 | 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 | ||
196 | 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 | ||
197 | 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 | ||
198 | ChiCTR1800015331 | 2018-04-01 | 2018-03-23 | Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease | Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease | Parkinson's disease | de novo PD patients:levodopa 4 weeks;de novo PD patients:pramipexole 4 weeks;de novo PD patients:selegiline 4 weeks; | Institute of Psychology, Chinese Academy of Sciences | NULL | Recruiting | 50 | 80 | Both | de novo PD patients:50;de novo PD patients:50;de novo PD patients:50; | China | |
199 | EUCTR2017-004297-34-GB (EUCTR) | 31/03/2018 | 22/06/2018 | Use of low-dose zolpidem in Parkinson's. | A placebo controlled double blind randomised controlled proof of concept study of zolpidem for the treatment of motor and cognitive deficits in late-stage Parkinson’s - Zolpidem for treatment of motor and cognitive deficits in Parkinson's | 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: Stilnoct Product Name: Stilnoct Product Code: 207-3120 INN or Proposed INN: Zolpidem Tartrate | Aston University | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | United Kingdom | ||
200 | 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 | ||
201 | 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 | ||
202 | NCT03301272 (ClinicalTrials.gov) | March 22, 2018 | 13/9/2017 | Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease | Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study | Parkinson Disease | Drug: Onabotulinumtoxin A Injection;Other: Placebo | University of North Carolina, Chapel Hill | NULL | Completed | 45 Years | 80 Years | All | 16 | Phase 2 | United States |
203 | 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 |
204 | JPRN-UMIN000030930 | 2018/01/29 | 01/01/2019 | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease | Parkinson's disease | Administration of febuxostat 20 mg and inosine 500 mg twice a day for 58 days | StaGen Co. Ltd. | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
205 | NCT03440112 (ClinicalTrials.gov) | January 29, 2018 | 26/1/2018 | Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm | Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson | Parkinson Disease | Drug: Clarithromycin (Not used as of 4/2020);Drug: Placebo (Not used as of 4/2020);Drug: Transdermal flumazenil (Added 4/2020);Drug: Placebo (Added 4/2020) | Nicolaas Bohnen, MD, PhD | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | 50 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
206 | 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 |
207 | 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 | ||
208 | ChiCTR1800014542 | 2018-01-22 | 2018-01-20 | Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease | Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease | Parkinson's Disease | PD group:propofol;NPD group:propofol; | Xuanwu Hospital of CCMU | NULL | Recruiting | 18 | 65 | Both | PD group:40;NPD group:40; | China | |
209 | 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 | ||
210 | 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 | ||
211 | 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 | ||
212 | 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 | ||
213 | JPRN-UMIN000030084 | 2017/12/01 | 01/12/2017 | Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease | Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease - Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation | neuroinflammatory disorder, Parkinson's disease, Brain tumor | [18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes. Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes. [18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes | Kyoto University | NULL | Complete: follow-up complete | 50years-old | Not applicable | Male and Female | 12 | Phase 1,2 | Japan |
214 | 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 | |
215 | 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 | ||
216 | 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 |
217 | 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 |
218 | 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 | ||
219 | NCT02611167 (ClinicalTrials.gov) | November 1, 2017 | 11/11/2015 | Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease | Pilot Phase I Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease | Parkinson's Disease | Biological: Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg) | The University of Texas Health Science Center, Houston | NULL | Completed | 45 Years | 70 Years | All | 20 | Phase 1 | United States |
220 | 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 | ||
221 | NCT03205956 (ClinicalTrials.gov) | October 19, 2017 | 29/6/2017 | Measuring Parkinson's Disease Progression | Dopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PD | Parkinson's Disease | Drug: Levodopa | Kevin J. Black, MD | The Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 79 Years | All | 31 | Phase 1 | United States |
222 | 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 |
223 | 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 | ||
224 | NCT03769896 (ClinicalTrials.gov) | October 3, 2017 | 6/12/2018 | Nabilone for Non-motor Symptoms in Parkinson's Disease | Nabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal Study | Parkinson Disease | Drug: Nabilone 0.25 mg;Drug: Placebo | Medical University Innsbruck | NULL | Completed | 30 Years | 100 Years | All | 48 | Phase 2 | Austria |
225 | 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 | ||
226 | 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 | ||
227 | EUCTR2017-000192-86-AT (EUCTR) | 15/09/2017 | 10/08/2017 | Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...) | Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study | Subjects 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): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria | ||
228 | 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 | ||
229 | 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 |
230 | 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 | ||
231 | 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 | ||
232 | 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 | ||
233 | 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 | ||
234 | 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 | ||
235 | 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 | ||
236 | 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 | ||
237 | 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 | ||
238 | 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 |
239 | 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 |
240 | EUCTR2015-005814-31-ES (EUCTR) | 22/06/2017 | 21/04/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: 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 | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany | ||
241 | 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 | ||
242 | NCT03083132 (ClinicalTrials.gov) | June 13, 2017 | 7/3/2017 | Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD) | Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's Disease | Parkinson Disease | Drug: modafinil 50mg;Drug: Placebo oral capsule | University of Arkansas | NULL | Completed | 50 Years | 90 Years | All | 23 | Early Phase 1 | United States |
243 | 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 | ||
244 | 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 | ||
245 | 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 | ||
246 | 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 | ||
247 | 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 | ||
248 | 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 | ||
249 | NCT03115827 (ClinicalTrials.gov) | April 18, 2017 | 9/3/2017 | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease | Parkinson Disease | Drug: Droxidopa;Drug: Carbidopa | Vanderbilt University Medical Center | H. Lundbeck A/S;American Academy of Neurology | Completed | 18 Years | N/A | All | 15 | Phase 4 | United States |
250 | EUCTR2016-004629-18-NL (EUCTR) | 13/04/2017 | 17/01/2017 | The influence of stress on Parkinson's tremor | The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor | Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Propranolol Product Name: Propranolol HCl CF 40 mg tablet Product Code: RVG 55618 | Radboud University Nijmegen | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Netherlands | ||
251 | 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 |
252 | 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 | ||
253 | NCT02953665 (ClinicalTrials.gov) | April 3, 2017 | 21/10/2016 | Safety and Efficacy of Liraglutide in Parkinson's Disease | A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease | Parkinson Disease | Drug: Liraglutide;Drug: Placebo | Cedars-Sinai Medical Center | The Cure Parkinson's Trust;Novo Nordisk A/S | Completed | 25 Years | 85 Years | All | 63 | Phase 2 | United States |
254 | JPRN-UMIN000026128 | 2017/04/01 | 01/04/2017 | Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Parkinson's disease | administe pilocarpine and dipivefrine administe pilocarpine and dipivefrine | Nagoya University | NULL | Recruiting | 40years-old | 90years-old | Male and Female | 60 | Not selected | Japan |
255 | 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 | ||
256 | 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 | ||
257 | 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 |
258 | 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 | ||
259 | 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 |
260 | EUCTR2015-005814-31-CZ (EUCTR) | 03/03/2017 | 01/12/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with 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: 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 | 210 | 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;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
261 | 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 | ||
262 | 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 | ||
263 | 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 | ||
264 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Germany;United Kingdom | ||
265 | EUCTR2015-005814-31-DE (EUCTR) | 07/02/2017 | 24/05/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) | Subjects with 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: 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 | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany | ||
266 | JPRN-UMIN000025645 | 2017/02/01 | 17/01/2018 | Cross sectional analysis of Intestinal flora of Parkinson's disease: | Cross sectional analysis of Intestinal flora of Parkinson's disease: - Analysis of Intestinal flora of Parkinson's disease | Parkinson's disease | Levodopa/carbidopa intestinal gel | Juntendo University School of Medicine | NULL | Pending | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan |
267 | 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 | ||
268 | JPRN-UMIN000043848 | 2017/01/10 | 29/04/2021 | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial - SEMPDOABRCT | Overactive bladder | Treatment group receiving daily mirabegron 50mg for 12 weeks Placebo group | Al Zahraa Hospital | NULL | Complete: follow-up complete | 40years-old | 70years-old | Male and Female | 110 | Not applicable | Asia(except Japan) |
269 | 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 | ||
270 | NCT03034564 (ClinicalTrials.gov) | January 2017 | 25/1/2017 | A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease | Parkinson Disease;Fatigue;Parkinsonism | Drug: Northera;Drug: Placebo Oral Tablet | The Cooper Health System | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 4 | United States |
271 | 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 |
272 | 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 | ||
273 | 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 | ||
274 | 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 |
275 | ChiCTR2000037957 | 2016-12-01 | 2020-09-07 | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease | Deep brain stimulation in patients with Parkinson's disease | Experimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline; | Shanghai Jing'an District Central Hospital | NULL | Completed | 45 | 75 | Both | Experimental group:27;control group:9; | China | |
276 | NCT02934919 (ClinicalTrials.gov) | December 2016 | 14/10/2016 | Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study | Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study | Impulse Control Disorders;Parkinson Disease | Drug: Nalmefene | University Hospital, Clermont-Ferrand | NULL | Not yet recruiting | 18 Years | 80 Years | Both | 30 | Phase 2 | France |
277 | NCT02789020 (ClinicalTrials.gov) | December 2016 | 20/5/2016 | Image Parkinson's Disease Progression Study | Image Parkinson's Disease Progression Study | Parkinson's Disease | Drug: Rasagiline;Other: Placebo;Device: Magnetic Resonance Imaging;Device: functional Magnetic Resonance Imaging;Other: Physical Function Performance Test | University of Florida | National Institute of Neurological Disorders and Stroke (NINDS) | Active, not recruiting | 40 Years | 77 Years | All | 96 | Phase 2 | United States |
278 | 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 |
279 | 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 | ||
280 | 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 | ||
281 | 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 |
282 | 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 | ||
283 | NCT02847442 (ClinicalTrials.gov) | November 23, 2016 | 21/7/2016 | Efficacy and Safety of Opicapone in Clinical Practice | Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations | Parkinson's Disease With Wearing-off Motor Fluctuations | Drug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitor | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 518 | Phase 4 | Germany |
284 | 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 |
285 | 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 | ||
286 | 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 | ||
287 | 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 |
288 | EUCTR2016-001762-29-IT (EUCTR) | 08/11/2016 | 25/05/2017 | 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) | 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) - CTH-201 | 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: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Trade Name: AVALOX - 400 | SUNOVION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
289 | 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 |
290 | 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 |
291 | 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 |
292 | NCT02968433 (ClinicalTrials.gov) | November 2016 | 14/11/2016 | The Stanford Parkinson's Disease Plasma Study | The Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's Disease | Parkinson Disease(PD) | Drug: Infusions of young plasma | Stanford University | NULL | Active, not recruiting | 50 Years | 80 Years | All | 15 | Phase 1 | United States |
293 | EUCTR2015-001786-10-DE (EUCTR) | 24/10/2016 | 07/04/2016 | A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. | A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in 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: EPI-589 Product Code: EPI-589 INN or Proposed INN: Kinoquinone (proposed) Other descriptive name: (R)-troloxamide quinone | BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Germany;United Kingdom | ||
294 | 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 | ||
295 | EUCTR2016-002680-34-ES (EUCTR) | 20/10/2016 | 05/08/2016 | Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease. | Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease. | Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | Trade Name: Dexdor Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE Other descriptive name: DEXMEDETOMIDINA | Clínica Universidad de Navarra/Universidad de Navarra | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 4 | Spain | ||
296 | 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 | ||
297 | 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 | ||
298 | 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 | ||
299 | 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 | ||
300 | JPRN-UMIN000024312 | 2016/09/20 | 25/05/2017 | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. | Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. - Effect of febuxostat and inosine on CNS diseases | Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis | Treatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeks | Tsukuba International Clinical Pharmacology Clinic | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 12 | Not selected | Japan |
301 | 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 | ||
302 | NCT02869945 (ClinicalTrials.gov) | September 2016 | 4/8/2016 | Compensation Mechanisms in Parkinson's Disease | Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease | Parkinson Disease | Genetic: Identification of COMT HH, COMT HL or COMT LL genes;Other: Brain MRI with resting state scan;Other: Brain MPET | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 50 | N/A | France |
303 | EUCTR2015-003679-31-NL (EUCTR) | 09/08/2016 | 24/05/2016 | New therapeutic strategy in Parkinson’s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II | De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Not Recruiting | Female: yes Male: yes | 338 | Phase 2 | Portugal;Czech Republic;Spain;Austria;Netherlands | ||
304 | 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 |
305 | 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 |
306 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Germany;Italy;United Kingdom | ||
307 | 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 | ||
308 | 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 | ||
309 | EUCTR2015-003679-31-CZ (EUCTR) | 23/06/2016 | 28/01/2016 | New therapeutic strategy in Parkinson’s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II | De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Not Recruiting | Female: yes Male: yes | 338 | Phase 2 | Portugal;Czech Republic;Spain;Austria;Netherlands | ||
310 | EUCTR2015-005626-19-CZ (EUCTR) | 23/06/2016 | 14/04/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes | A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena) 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: CVT-301 Product Code: CVT-301 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
311 | EUCTR2015-005814-31-IT (EUCTR) | 23/06/2016 | 14/01/2021 | Not available | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | advanced 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;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: LEVODOPA (LD) INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA (CD) | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
312 | 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 | ||
313 | 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 | ||
314 | EUCTR2015-005626-19-ES (EUCTR) | 13/06/2016 | 20/04/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodes | A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | 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 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, a wholly owned subsidiary of Acorda | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
315 | JPRN-jRCTs051180098 | 09/06/2016 | 06/03/2019 | The DAT-SPECT study for the benefit of Selegilline or Zonisamide 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 | Parkinson's disease;034034 | L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365. | Ito Hidefumi | NULL | Not Recruiting | >= 55age old | < 80age old | Both | 120 | Phase 2 | Japan |
316 | 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 | ||
317 | 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 | ||
318 | 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 | ||
319 | 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 | ||
320 | 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 |
321 | 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 | ||
322 | 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 | ||
323 | 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 | ||
324 | 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 | ||
325 | 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 |
326 | JPRN-UMIN000022022 | 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 | A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease | Parkinson diseaseChronic constipation | Study drug group: A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide Control group: Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment | Dokkyo Medical University | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 64 | Not selected | Japan |
327 | JPRN-UMIN000022187 | 2016/05/06 | 06/05/2016 | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease - Analysis of caffeine absorption in patients with Parkinson's disease | Parkinson's disease | PD group, 200 mg caffeine administration, qd, 1 day Control group, 200 mg caffeine administration, qd, 1 day | Department of Neurology, Juntendo University | NULL | Complete: follow-up complete | 40years-old | 60years-old | Male and Female | 20 | Not applicable | Japan |
328 | 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 | ||
329 | NCT02726386 (ClinicalTrials.gov) | May 2016 | 29/3/2016 | A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC Infusion | A Multicenter, International, Open-label, Safety Study of ND0612, 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 | NeuroDerm Ltd. | NULL | Active, not recruiting | 30 Years | N/A | All | 210 | Phase 2 | United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain |
330 | 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 |
331 | NCT02812147 (ClinicalTrials.gov) | May 2016 | 25/5/2016 | Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease | Effect of L-Dihydoxyphenylserine (L-DOPS, Northera) a Central and Peripheral Norepinephrine Agent on Locomotion, Postural Stability (Balance), and Fall Risk Reduction in Parkinson Disease (PD) | Parkinson Disease | Drug: L-DOPS;Drug: Placebo | St. Joseph's Hospital and Medical Center, Phoenix | Arizona State University, Tempe | Active, not recruiting | 30 Years | 83 Years | All | 20 | Phase 2 | United States |
332 | 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 | ||
333 | 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 | ||
334 | 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 | ||
335 | 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 | ||
336 | EUCTR2015-003679-31-PT (EUCTR) | 18/04/2016 | 28/01/2016 | New therapeutic strategy in Parkinson’s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II | De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Not Recruiting | Female: yes Male: yes | 338 | Phase 2 | Portugal;Czech Republic;Spain;Austria;Netherlands | ||
337 | 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 | ||
338 | 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 | ||
339 | EUCTR2015-003679-31-AT (EUCTR) | 06/04/2016 | 11/01/2016 | New therapeutic strategy in Parkinson’s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II | De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Not Recruiting | Female: yes Male: yes | 372 | Phase 2 | Portugal;France;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom | ||
340 | EUCTR2015-005067-17-CZ (EUCTR) | 01/04/2016 | 25/01/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | 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 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Spain;Poland | ||
341 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | 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: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
342 | 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 | ||
343 | EUCTR2015-001523-24-FR (EUCTR) | 25/03/2016 | 20/04/2016 | Evaluation of the pain relief of prolonged-release oxycodone and of L-Dopa, versus placebo, in Parkinson's disease. | Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA | Central neuropathic pain in Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: oxycontin LP 5mg Product Name: Oxycontin LP 5mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 10mg Product Name: Oxycontin LP 10mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: oxycontin LP 20mg Product Name: Oxycontin LP 20mg INN or Proposed INN: oxycodone Other descriptive name: OXYCODONE HYDROCHLORIDE Trade Name: Modopar 125 Product Name: Modopar 125 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: BENSERAZIDE Trade Name: Modopar 62,5 Product Name: Modopar 62,5 INN or Proposed INN: levodopa Other descriptive name: LEVODOPA | UHToulouse | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2;Phase 3 | France | ||
344 | 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 |
345 | EUCTR2015-003679-31-ES (EUCTR) | 21/03/2016 | 13/01/2016 | New therapeutic strategy in Parkinson?s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone - FAIRPARK II | De Novo 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: Ferriprox 500 mg Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 338 | Phase 3 | Spain | ||
346 | 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 | ||
347 | EUCTR2015-005067-17-ES (EUCTR) | 14/03/2016 | 17/02/2016 | A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson?s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD?) | 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 35mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Product Name: CVT-301 Product Code: CVT-301 50mg INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA | Civitas Therapeutics, a wholly owned subsidiary of Acorda Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United States;Czech Republic;Canada;Poland;Spain | ||
348 | 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 | |||
349 | 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 | ||
350 | JPRN-UMIN000021236 | 2016/03/01 | 01/03/2016 | Investigation in effect of aroma therapy using magnetoencepharography | Investigation in effect of aroma therapy using magnetoencepharography - Aroma with MEG | Normal volunteer, Epilepsy patients, Parkinson disease patients | aroma 1 Trans-nasal administration of lavender essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. aroma 2 Trans-nasal administration of grapefruit essence Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. fragrant Trans-nasal administration of fragrant Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes After the administration, MEG signals will be recorded for 4 minutes Also, the subjects were evaluated their moods and awareness. | Osaka University Graduate School of Medicine Department of Neurosurgery | NULL | Complete: follow-up continuing | 20years-old | 80years-old | Male and Female | 10 | Phase 1 | Japan |
351 | NCT02994719 (ClinicalTrials.gov) | March 1, 2016 | 21/12/2015 | Gait Analysis in Neurological Disease | Gait Pattern Analysis in Neurological Disease | Parkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington Disease | Drug: Anti-Parkinson medication;Device: Deep Brain Stimulation | Beth Israel Deaconess Medical Center | NULL | Active, not recruiting | 18 Years | 85 Years | All | 120 | United States | |
352 | 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 |
353 | 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 |
354 | 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 |
355 | EUCTR2015-004238-85-ES (EUCTR) | 27/01/2016 | 10/12/2015 | Brain SPECT in premotor stage of Parkinson disease | Ictal brain SPECT in the premotor stage of Parkinson disease | Parkinson 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: CERETEC (TM) Estabilizado Product Name: Ceretec INN or Proposed INN: Ceretec Other descriptive name: TECHNETIUM (99MTC) EXAMETAZIME | IDIBAPS | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain | ||
356 | EUCTR2015-003679-31-FR (EUCTR) | 25/01/2016 | 25/02/2016 | New therapeutic strategy in Parkinson’s disease | Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II | De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone DR INN or Proposed INN: DEFERIPRONE | Centre Hospitalier Régional et Universitaire de Lille | NULL | Not Recruiting | Female: yes Male: yes | 338 | Phase 2 | Portugal;France;Czech Republic;Spain;Austria;Netherlands | ||
357 | EUCTR2015-001786-10-GB (EUCTR) | 18/01/2016 | 23/11/2015 | A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. | A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in 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 MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: EPI-589 Product Code: EPI-589 Other descriptive name: (R)-troloxamide quinone | BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Germany;United Kingdom | ||
358 | 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 |
359 | 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 | ||
360 | 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 | ||
361 | 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 | ||
362 | 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 | ||
363 | NCT02616120 (ClinicalTrials.gov) | December 2015 | 20/11/2015 | Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease | Efficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease Patients | Parkinson's Disease | Drug: SQJZ herbal mixtures;Drug: Placebo | Dongzhimen Hospital, Beijing | NULL | Recruiting | 18 Years | 80 Years | All | 240 | Phase 2 | China |
364 | 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 | ||
365 | EUCTR2015-002631-17-ES (EUCTR) | 19/11/2015 | 03/11/2015 | A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients | An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa Product Name: Duodopa Trade Name: Sinemet Plus Product Name: Sinemet Plus | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
366 | 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 |
367 | JPRN-UMIN000019676 | 2015/11/10 | 10/11/2015 | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease | Parkinson's disease | taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | NULL | Complete: follow-up complete | 20years-old | 100years-old | Male and Female | 20 | Not selected | Japan |
368 | 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 | ||
369 | 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 |
370 | 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 |
371 | JPRN-UMIN000019090 | 2015/11/04 | 01/11/2015 | Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water | Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water - Dose finding test of reduced form of Coenzyme Q10 for Parkinson's disease | Parkinson's disease | reduced form of CoQ10 300mg 16weeks reduced form of CoQ10 600mg 16weeks reduced form of CoQ10 600mg 16weeks hydrogen water 500ml(Suisosui 7.0) 16weeks | Juntendo University Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 45 | Not selected | Japan |
372 | 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 | ||
373 | 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 |
374 | NCT02632279 (ClinicalTrials.gov) | November 2015 | 26/11/2015 | Tryptophan Depletion in PD Patients Treated With STN DBS | Tryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor Functions | Parkinson's Disease | Dietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFF | Maastricht University Medical Center | Netherlands Brain Foundation | Terminated | N/A | N/A | All | 7 | N/A | Netherlands |
375 | 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 |
376 | NCT02668835 (ClinicalTrials.gov) | November 2015 | 4/12/2015 | GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial | GADGET-PD Genetic and Digital Diagnosis of Essential Tremor and Parkinson's Disease Trial | Parkinson Disease;Essential Tremor | Device: Non intervention-Monitoring device;Genetic: Non intervention-Genetic testing | Scripps Translational Science Institute | Michael J. Fox Foundation for Parkinson's Research;Intel Corporation | Completed | 18 Years | N/A | All | 67 | NULL | |
377 | 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 |
378 | 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 |
379 | NCT02914366 (ClinicalTrials.gov) | November 2015 | 8/9/2016 | Ambroxol as a Treatment for Parkinson's Disease Dementia | Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia | Parkinson's Disease Dementia | Drug: Ambroxol;Other: Placebo | Lawson Health Research Institute | Weston Brain Institute;Western University, Canada;London Health Sciences Centre | Active, not recruiting | 50 Years | N/A | All | 55 | Phase 2 | Canada |
380 | 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 | ||
381 | 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 |
382 | EUCTR2015-003045-26-SE (EUCTR) | 23/10/2015 | 15/09/2015 | Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease. | [18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease. | Patients with newly clinically diagnosed untreated idiopathic parkinsonism 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: [18F]FE-PE2I INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane Trade Name: DaTSCAN INN or Proposed INN: IOFLUPANE (123I) Product Name: 15O H2O INN or Proposed INN: [15O]H2O | Umeå University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Sweden | ||
383 | JPRN-UMIN000019082 | 2015/10/10 | 22/09/2015 | the effect of smell dysfunction using hydrogen gas for parkinson disease | the effect of smell dysfunction using hydrogen gas for parkinson disease - the effect of smell dysfunction using hydrogen gas for parkinson disease | parkinson's disease | we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air. we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. | Nagoya University Graduate School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
384 | 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 |
385 | 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 | ||
386 | 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 | ||
387 | 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 | |||
388 | 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 | ||
389 | 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 | ||
390 | 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 | ||
391 | NCT02917122 (ClinicalTrials.gov) | August 2015 | 30/6/2016 | The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease | The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease | Parkinson Disease;Depression | Device: active tDCS;Drug: Sertraline;Device: sham tDCS | National Cheng-Kung University Hospital | NULL | Active, not recruiting | 18 Years | 75 Years | Both | 40 | Phase 1/Phase 2 | NULL |
392 | 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 |
393 | 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 | ||
394 | 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 | ||
395 | 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 | ||
396 | 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 | ||
397 | NCT02450786 (ClinicalTrials.gov) | June 2015 | 14/5/2015 | Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI) | Parkinson's Disease | Drug: Donepezil | Yonsei University | NULL | Active, not recruiting | 40 Years | N/A | All | 80 | Phase 2 | Korea, Republic of | |
398 | 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 | ||
399 | 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 |
400 | 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 | ||
401 | 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 | ||
402 | 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 |
403 | 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 | ||
404 | 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 | ||
405 | 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 | ||
406 | EUCTR2014-002697-37-GB (EUCTR) | 15/04/2015 | 19/03/2015 | Study of Melatonin for treatment of Nocturia in PD | Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease - Study of Melatonin for treatment of Nocturia in PD | Parkinson's DiseaseNocturia MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Circadin® Product Name: Melatonin Product Code: AS2 INN or Proposed INN: Melatonin | University College London | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom | ||
407 | 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 | ||
408 | JPRN-UMIN000017036 | 2015/04/03 | 03/04/2015 | Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. | Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. - Association of ghrelin and leptin in cardiovascular autonomic dysfunction | autonomic failure such as Parkinson's disease | blood test of Leptin and Ghrelin blood test of Leptin and Ghrelin | Nagoya University Graduate School of Medicine | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
409 | JPRN-UMIN000016591 | 2015/04/01 | 20/02/2015 | Clinical trial of balance exercise "Assist" | Clinical trial of balance exercise "Assist" - Balance Exercise Assist | Stroke, Parkinson disease, Osteoarthrosis | use of balance exercise assist ordinary balance exercise | Juntendo University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 40 | Not applicable | Japan |
410 | JPRN-UMIN000016734 | 2015/04/01 | 01/04/2015 | The evaluation of duloxetine effect for the parkinsonism and gait freezing | The evaluation of duloxetine effect for the parkinsonism and gait freezing - The evaluation of effect of duloxetine and parkinsonism | Parkinson's disease | Drug ; Duloxetine Duraion; SEP012014-AUG312016 Doseage; 20mg/day or 40mg/day Times; one time per day P.O. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 30 | Not selected | Japan |
411 | NCT02359448 (ClinicalTrials.gov) | April 2015 | 4/2/2015 | Melatonin for Nocturia in Parkinson's Disease | Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease | Parkinson's Disease;Nocturia | Drug: Melatonin | University College, London | NULL | Not yet recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
412 | 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 | ||
413 | 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 | ||
414 | 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 | ||
415 | JPRN-UMIN000016664 | 2015/03/01 | 01/03/2015 | Effect of nicotine patch in Cognitive function improvement in Parkinson's disease | Effect of nicotine patch in Cognitive function improvement in Parkinson's disease - Effect of nicotine patch in Cognitive function improvement | Parkinson's disease | nicotine patch | Department of Clinical Pharmacology and Neurology Ehime University graduated School of Medicine | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
416 | 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 | ||
417 | JPRN-UMIN000016485 | 2015/02/25 | 09/02/2015 | Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome | Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome - PD-1 | Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients | Intravenous injection of 18F-fluoro-dopa and 11C-raclopride PET imaging | Institute of Biomedical Research and Innovation | NULL | Complete: follow-up complete | 35years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
418 | 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 | ||
419 | 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 |
420 | 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 | ||
421 | 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 |
422 | 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 | ||
423 | NCT02480803 (ClinicalTrials.gov) | December 19, 2014 | 4/5/2015 | INfusion VErsus STimulation in Parkinson's Disease | Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation | Parkinson's Disease | Drug: Continuous intrajejunal infusion of levodopa-carbidopa;Device: deep brain stimulation | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ZonMw: The Netherlands Organisation for Health Research and Development | Active, not recruiting | 18 Years | N/A | All | 66 | Phase 4 | Netherlands |
424 | NCT03116308 (ClinicalTrials.gov) | November 21, 2014 | 12/4/2017 | Effect of Food on Opicapone | Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects | Parkinson Disease | Drug: Opicapone (OPC) | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
425 | NCT02281474 (ClinicalTrials.gov) | November 2014 | 27/10/2014 | Nilotinib in Cognitively Impaired Parkinson Disease Patients 001 | Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-Synuclein | Parkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body Disease | Drug: Nilotinib | Georgetown University | NULL | Completed | 40 Years | 90 Years | Both | 12 | Phase 1 | United States |
426 | NCT02240030 (ClinicalTrials.gov) | November 2014 | 11/9/2014 | Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) | Idiopathic Parkinson's Disease | Drug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 351 | Phase 3 | United States;Canada;Czechia;Poland;Spain;Czech Republic |
427 | NCT02312232 (ClinicalTrials.gov) | November 2014 | 2/12/2014 | Pharmacokinetic Study in Healthy Males | Pharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy Males | Parkinson's Disease | Drug: levodopa, carbidopa, ODM-104 | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 65 Years | Male | 20 | Phase 1 | Finland |
428 | NCT02168842 (ClinicalTrials.gov) | November 2014 | 18/6/2014 | Efficacy of Isradipine in Early Parkinson Disease | Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease | Parkinson Disease | Drug: Isradipine;Drug: Placebo (for Isradipine) | University of Rochester | National Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study Group | Completed | 30 Years | N/A | All | 336 | Phase 3 | United States;Canada |
429 | NCT02278588 (ClinicalTrials.gov) | November 2014 | 28/10/2014 | Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease. | Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease. | Parkinson's Disease | Drug: Rasagiline | State University of New York at Buffalo | NULL | Completed | N/A | N/A | All | 45 | United States | |
430 | EUCTR2014-000335-17-GB (EUCTR) | 28/10/2014 | 23/07/2014 | Rotigotine and memory in Parkinson's. | The Effect of Rotigotine on Memory in Idiopathic Parkinson's Disease without Cognitive Impairment - Rotigotine and Memory in Parkinson's. | Idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rotigotine INN or Proposed INN: Rotigotine Product Name: levodopa CR (controlled release) INN or Proposed INN: levodopa Product Name: Rasagiline INN or Proposed INN: Rasagiline Product Name: Selegiline INN or Proposed INN: selegiline | Research and Development University Hospital of North Staffordshire | Keele University | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom | |||
431 | 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 | ||
432 | 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 | ||
433 | 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 | ||
434 | NCT02274324 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease | Parkinson Disease | Dietary Supplement: different diets | Sheba Medical Center | Tel Aviv University | Not yet recruiting | 40 Years | 80 Years | Both | 20 | N/A | NULL |
435 | NCT02259049 (ClinicalTrials.gov) | October 2014 | 3/10/2014 | The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease | The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease | Blood Pressure | Dietary Supplement: L-tyrosine;Dietary Supplement: Sugar Pill | New York Institute of Technology | NULL | Completed | 40 Years | 84 Years | Both | 6 | Phase 0 | United States |
436 | 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 |
437 | 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 |
438 | 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 |
439 | EUCTR2014-000868-17-ES (EUCTR) | 26/06/2014 | 17/03/2014 | Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators | Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators | Parkinson's disease MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | Trade Name: Dexdor Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE Other descriptive name: DEXMEDETOMIDINA Trade Name: Propofol-Lipuro Product Name: Propofol-Lipuro INN or Proposed INN: PROPOFOL Other descriptive name: PROPOFOL | Clínica Universidad de Navarra/Universidad de Navarra | NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
440 | 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 | ||
441 | NCT02780895 (ClinicalTrials.gov) | May 2014 | 12/5/2016 | Parkinsonian Brain Repair Using Human Stem Cells | Human OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's Disease | Idiopathic Parkinson Disease | Drug: Human Stem Cells | Celavie Bioscences, LLC | Hospital Angeles del Pedregal | Active, not recruiting | 18 Years | 75 Years | Both | 8 | Phase 1 | Mexico |
442 | 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 | ||
443 | 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 | ||
444 | EUCTR2013-003363-64-GB (EUCTR) | 03/04/2014 | 11/03/2014 | Trial of Exenatide for Parkinson's disease | A randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease. - Exenatide-PD | Parkinson's Disease 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: Bydureon Product Name: Exenatide INN or Proposed INN: exenatide | University College London | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United Kingdom | ||
445 | NCT02111122 (ClinicalTrials.gov) | April 2014 | 8/4/2014 | Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | Sleep-wake Disturbances in Motor-phase Parkinson's Disease | Drug: Sodium Oxybate;Drug: Placebo | Christian Baumann | NULL | Completed | 18 Years | 90 Years | All | 16 | Phase 2 | Switzerland |
446 | 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 | ||
447 | 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 | ||
448 | 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 |
449 | 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 | ||
450 | 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 | ||
451 | 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 | ||
452 | 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 | ||
453 | NCT02305316 (ClinicalTrials.gov) | February 2014 | 28/11/2014 | Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone | Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers | Parkinson Disease | Drug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronized | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
454 | 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 |
455 | 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 | ||
456 | 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 |
457 | NCT02046434 (ClinicalTrials.gov) | January 2014 | 23/1/2014 | Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain | Phenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From Brain | Parkinson's Disease | Drug: Glycerol Phenylbutyrate | University of Colorado, Denver | NULL | Active, not recruiting | 21 Years | 80 Years | All | 40 | Phase 1 | United States |
458 | NCT02018406 (ClinicalTrials.gov) | December 2013 | 30/10/2013 | Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury | Neurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson Disease | Drug: Combination injection of EPO and G-CSF;Drug: Injection of normal saline | Yonsei University | NULL | Active, not recruiting | 20 Years | N/A | All | 16 | Phase 1/Phase 2 | Korea, Republic of | |
459 | 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 |
460 | 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 | ||
461 | 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 |
462 | 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 |
463 | 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 | |||
464 | 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 | ||
465 | EUCTR2011-002827-17-SK (EUCTR) | 17/09/2013 | 04/03/2013 | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | Early stage 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] | Trade Name: Local Trade Name, 2mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 4mg Product Name: ropinirole PR, 2mg Product Code: SK&F101468 INN or Proposed INN: ROPINIROLE Trade Name: Local Trade Name, 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 | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
466 | 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 | ||
467 | 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 | ||
468 | 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 | |||
469 | JPRN-UMIN000011111 | 2013/07/16 | 15/07/2013 | Spinal blood flow and metabolism in neurological diseases | Spinal blood flow and metabolism in neurological diseases - Spinal blood flow and metabolism in neurological diseases | motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophy | PET scan study with 11C-flumazenil PET scan study with 18F- FDG PET scan study with 15O-H2O | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 70 | Not applicable | Japan |
470 | 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 | |||||
471 | 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 |
472 | JPRN-UMIN000010752 | 2013/05/17 | 17/05/2013 | A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. | A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. - Donepezil study on Parkinson\'s disease with dementia | Parkinson's disease | donepezil | Kansai Medical University | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan |
473 | EUCTR2012-005822-31-IT (EUCTR) | 13/05/2013 | 20/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Parkinson's Disease MedDRA version: 15.1;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 | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;United Kingdom;Italy | ||
474 | EUCTR2013-000827-15-IT (EUCTR) | 11/05/2013 | 15/03/2013 | LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE | LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT | Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rotigotine Product Name: neurpro Product Code: SPM962 | Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
475 | JPRN-UMIN000010596 | 2013/05/01 | 01/05/2013 | Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo | Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo - MAP-J | Parkinson's disease | Memantine preceding arm Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months. Amantadine preceding arm Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male | 40 | Not selected | Japan |
476 | NCT03022201 (ClinicalTrials.gov) | May 2013 | 23/11/2016 | Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's Disease | Therapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority Trial | Parkinson's Disease,Idiopathic | Drug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701 | Seoul National University Hospital | NULL | Completed | 20 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
477 | 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 | ||
478 | 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 | |||
479 | EUCTR2011-002827-17-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. | 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] | 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 | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
480 | EUCTR2012-005822-31-GB (EUCTR) | 18/04/2013 | 05/03/2013 | A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) - Inhaled CVT-301 in Subjects with Parkinson’s Disease | Parkinson's Disease MedDRA version: 14.1;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 | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Serbia;Italy;United Kingdom | ||
481 | JPRN-UMIN000010778 | 2013/04/10 | 22/05/2013 | Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 | Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2 | Parkinson disease | 5mg donepezil hydrocloride | National Hospital of Utano | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
482 | 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 |
483 | 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 | ||
484 | 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 | |||
485 | 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 | ||
486 | 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 |
487 | 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 | ||
488 | 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 |
489 | 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 |
490 | JPRN-UMIN000010014 | 2013/02/28 | 13/02/2013 | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease | Parkinson's disesase | hydrogen water made by "Suisosui5.0" placebo-water (nitrogen filling water) | Juntendo University School of Medicine, Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
491 | 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 | ||
492 | 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 | ||
493 | EUCTR2012-000801-64-GB (EUCTR) | 09/02/2013 | 26/11/2012 | A study of the effects of medication on memory in Parkinson's Disease | A Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease. - Medication and Memory in Parkinson’s Disease (MeMory PaD) | Idiopathic Parkinson's Disease MedDRA version: 17.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mirapexin extended release various strengths Product Name: Pramipexole dihydrochloride monohydrate extended release Product Code: N/A INN or Proposed INN: pramipexole dihydrochloride monohydrate Other descriptive name: Mirapexin Trade Name: Requip prolonged release Product Name: Ropinirole hydrochloride prolonged release INN or Proposed INN: Ropinirole (as hydrochloride) Other descriptive name: Requip XL prolonged-release | University Hospital of North Staffordshire | Keele University | Not Recruiting | Female: yes Male: yes | 55 | Phase 4 | United Kingdom | ||
494 | NCT02059733 (ClinicalTrials.gov) | February 2013 | 7/2/2014 | Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism | Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PET | Parkinson's Disease | Drug: 18F-DTBZ | Chang Gung Memorial Hospital | NULL | Completed | 20 Years | 80 Years | All | 72 | Phase 2 | Taiwan |
495 | 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 | ||
496 | 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 | |||
497 | 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 | |||
498 | 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 | ||
499 | JPRN-UMIN000017695 | 2013/01/01 | 27/05/2015 | Oxybuprocaine for apraxia of lid opening in Parkinson's disease | Oxybuprocaine for apraxia of lid opening in Parkinson's disease - Oxybuprocain for ALO | apraxia of lid opening in Parkinson's disease | Arm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment | Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
500 | 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 | |||
501 | NCT01738191 (ClinicalTrials.gov) | November 2012 | 28/11/2012 | Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) | Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog) | Parkinson's Disease;Cognitive Impairment | Drug: Atomoxetine;Drug: Placebo | Medical University of South Carolina | Michael J. Fox Foundation for Parkinson's Research | Completed | 35 Years | 75 Years | All | 30 | Phase 2 | United States |
502 | 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 |
503 | 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 |
504 | NCT01721460 (ClinicalTrials.gov) | November 2012 | 30/10/2012 | Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus | Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery | Parkinson's Disease;Deep Brain Stimulation Surgery | Drug: Dexmedetomidine | University of Wisconsin, Madison | NULL | Completed | 18 Years | 85 Years | All | 6 | Phase 4 | United States |
505 | 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 |
506 | 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 |
507 | JPRN-UMIN000009099 | 2012/10/01 | 12/10/2012 | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia - The effect of lidocaine injection in Parkinson's disease patients with camptorcormia | Parkinson's disease | lidocaine injection into the external oblique normal saline injection into the external oblique | Parkinson's disease and Movement Disorder Center | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
508 | 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 |
509 | 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 | ||
510 | 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 | |||
511 | 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 |
512 | 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 | ||
513 | EUCTR2012-000122-21-DK (EUCTR) | 10/08/2012 | 07/06/2012 | Improving the blood pressure regulating system in patients with parkinsons disease | Acethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease | Ortostatic hypotension in patients with Parkinsons disease MedDRA version: 14.1;Level: PT;Classification code 10031127;Term: Orthostatic hypotension;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Mestinon Product Name: Mestinon INN or Proposed INN: PYRIDOSTIGMINE BROMIDE Other descriptive name: Mestinon | Department of Neurology, Roskilde Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Denmark | ||
514 | EUCTR2012-001530-34-NL (EUCTR) | 09/08/2012 | 09/08/2012 | Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s Disease | Varenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study - Vareniciline for Excessive daytime Sleepiness in PArkinson’s disease (VESPA) | 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: Champix INN or Proposed INN: VARENICLINE Other descriptive name: VARENICLINE TARTRATE | VU University Medical Center | Center Human Drug Research | Not Recruiting | Female: yes Male: yes | 32 | Phase 3 | Netherlands | ||
515 | 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 |
516 | JPRN-UMIN000008138 | 2012/07/01 | 01/07/2012 | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease - Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease | Parkinson's disease | Silodosin 8mg BID | Juntendo University School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male | 100 | Not selected | Japan |
517 | 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 |
518 | 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 | ||
519 | JPRN-JapicCTI-121880 | 11/6/2012 | Phase II clinical study in patients with Parkinson's disease not taking L-DOPA | A randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA | Parkinson's disease | Intervention name : HP-3000(ropinirole hydrochloride patch) Dosage And administration of the intervention : Transdermal, once daily Control intervention name : HP-3000 placebo Dosage And administration of the control intervention : Transdermal, once daily | Hisamitsu Pharmaceutical Co.,Inc. | NULL | 20 | 79 | BOTH | Phase 2 | NULL | |||
520 | 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 | |||
521 | 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 |
522 | NCT02786667 (ClinicalTrials.gov) | June 2012 | 18/5/2016 | Non Motors Aspects in De Novo Parkinson's Disease | Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects. | Parkinson Disease;Apathy | Drug: Rotigotine;Drug: Placebo | University Hospital, Grenoble | NULL | Active, not recruiting | 30 Years | 72 Years | All | 199 | Phase 3 | France |
523 | 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 |
524 | 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 | |||
525 | 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 | |||
526 | 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 |
527 | EUCTR2012-000181-37-GB (EUCTR) | 25/04/2012 | 27/02/2012 | A study investigating the safety of CVT-301 in patients with Parkinson's Disease | A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Israel;United Kingdom | ||
528 | 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 | ||
529 | 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 | |||
530 | EUCTR2011-005839-91-ES (EUCTR) | 02/04/2012 | 11/01/2012 | Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. | Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. - IMULPARK | 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: GABAPENTINA KERN PHARMA INN or Proposed INN: GABAPENTINA Other descriptive name: GABAPENTIN | ASOCIACIÓN INSTITUTO BIODONOSTIA | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Spain | ||
531 | JPRN-UMIN000007617 | 2012/04/01 | 30/03/2012 | Effect of lidocaine injection for postural deformities in Parkinson's disease | Effect of lidocaine injection for postural deformities in Parkinson's disease - Lidocaine injection for postural deformities | Parkinson's disease | intramuscular injection of lidocaine | Dept. of Clinical pharmacology and Neurology, Ehime University | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
532 | NCT01556165 (ClinicalTrials.gov) | April 2012 | 13/3/2012 | Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Parkinson's Disease | Drug: rasagiline;Drug: placebo | H. Lundbeck A/S | NULL | Completed | 35 Years | N/A | All | 130 | Phase 3 | China |
533 | 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 |
534 | 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 | |||
535 | 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 | |||
536 | 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 | |||
537 | 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 | |||
538 | 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 | |||
539 | 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 | |||
540 | 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 | |||
541 | 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 | |||
542 | 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 |
543 | NCT02039024 (ClinicalTrials.gov) | March 2012 | 15/1/2014 | Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET | Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PET | Parkinson's Disease | Drug: 18F- DTBZ | Chang Gung Memorial Hospital | National Science Council, Taiwan | Completed | 20 Years | 80 Years | Both | 18 | Phase 2 | Taiwan |
544 | 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 | ||
545 | 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 | |||
546 | NCT01673724 (ClinicalTrials.gov) | February 2012 | 23/8/2012 | Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease | Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study | Parkinson's Disease | Drug: pramipexole;Drug: Bromocriptine | Sandoz | NULL | Completed | 30 Years | N/A | All | 121 | Phase 4 | Korea, Republic of |
547 | EUCTR2009-015170-35-GB (EUCTR) | 27/01/2012 | 21/12/2011 | Study across 22 UK hospitals investigating if a drug called Donepezil Hydrochloride can help people with an early form of Parkinson's Disease dementia. | Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD) - Donepezil in Early Dementia Associated with Parkinson's Disease | Parkinson's disease with mild dementia (PDD);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Pridia (Donepezil Hydrochloride) 5mg Product Name: Pridia 5mg INN or Proposed INN: Donepezil hydrochloride Trade Name: Pridia 10mg Product Name: Pridia 10mg INN or Proposed INN: Donepezil hydrochloride | The Newcastle upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
548 | 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 |
549 | 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 | |||
550 | 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 | ||||
551 | 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 | |||
552 | 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 | ||
553 | 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 | ||
554 | 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 | ||
555 | 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 | |||
556 | 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 | ||
557 | 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 |
558 | NCT02319395 (ClinicalTrials.gov) | November 2011 | 29/9/2014 | Behavioural Addiction and Genetics in Parkinson's Disease | Behavioural Addiction and Genetics in Parkinson's Disease | Parkinson Disease;Impulse Control Disorders | Genetic: Blood Sampling and DNA collection | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 332 | N/A | France |
559 | NCT01291537 (ClinicalTrials.gov) | November 2011 | 7/2/2011 | Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients | Parkinson's Disease | Drug: Duodopa;Drug: best médical treatment | Poitiers University Hospital | NULL | Completed | 18 Years | 80 Years | Both | 56 | Phase 2 | France | |
560 | 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 |
561 | NCT01736891 (ClinicalTrials.gov) | November 2011 | 27/11/2012 | Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations | Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China) | Parkinson´s Disease | Drug: Rasagiline;Drug: Placebo | Chongqing Fortune Pharmaceutical Co., Ltd. | Beijing Bionovo Medicine Development Co., Ltd. | Completed | 30 Years | 75 Years | Both | 268 | Phase 3 | China |
562 | NCT01556100 (ClinicalTrials.gov) | November 2011 | 6/3/2012 | Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression | Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression | Parkinson Disease | Drug: 18F-DTBZ AV-133 | Chang Gung Memorial Hospital | NULL | Completed | 20 Years | N/A | All | 40 | Phase 2 | NULL |
563 | 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 | ||
564 | 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 | ||||
565 | 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 |
566 | 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 |
567 | NCT01385735 (ClinicalTrials.gov) | October 2011 | 28/6/2011 | Emotion, Mood and Executive Function in Parkinson`s Disease (PD) | Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s Disease | Parkinson Disease | Drug: Rasagiline;Drug: Placebo | St. Josef Hospital Bochum | NULL | Not yet recruiting | 30 Years | 75 Years | Both | 70 | Phase 4 | Germany |
568 | 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 | ||
569 | 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 | ||
570 | 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 |
571 | EUCTR2011-001148-31-GB (EUCTR) | 13/09/2011 | 17/08/2011 | A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1 | A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1 | Parkinson's disease | Trade Name: Ferrprox (Deferiprone) Product Name: Deferiprone (Ferriprox) INN or Proposed INN: Deferiprone | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
572 | 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 | ||
573 | 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 | ||
574 | 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 | ||
575 | 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 | |||
576 | 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 | ||
577 | 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 | ||
578 | 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 |
579 | 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 | |||
580 | 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 | ||
581 | 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 | ||
582 | 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 | ||||
583 | 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 | ||
584 | 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 | ||
585 | 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 | |||
586 | 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 | |||
587 | 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 | |||
588 | 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 | ||
589 | 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 | ||
590 | 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 | ||
591 | EUCTR2009-013552-72-PL (EUCTR) | 08/06/2011 | 23/02/2011 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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 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 | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
592 | 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 |
593 | NCT01528592 (ClinicalTrials.gov) | June 2011 | 31/1/2012 | PharmacoMRI of Parkinson Disease | A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease | Parkinson's Disease | Drug: Carbidopa-Levodopa | Northwestern University | NULL | Completed | 30 Years | N/A | All | 18 | N/A | United States |
594 | 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 | ||
595 | 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 | |||
596 | EUCTR2009-015162-57-ES (EUCTR) | 23/05/2011 | 31/03/2011 | Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) | Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) | Enfermedad de Parkinson 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: 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 | Portugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden | ||
597 | 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 | ||
598 | 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 | |||
599 | 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 | |||
600 | 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 | ||
601 | 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 | ||
602 | 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 |
603 | EUCTR2010-022366-27-CZ (EUCTR) | 21/04/2011 | 23/11/2010 | BIPARK STUDY II | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | |||
604 | EUCTR2010-022366-27-BE (EUCTR) | 18/04/2011 | 01/02/2011 | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease 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: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Czech Republic;Estonia;Belgium;United Kingdom | ||
605 | 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 | ||
606 | 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 | |||
607 | 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 | ||
608 | 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 |
609 | EUCTR2009-013552-72-BG (EUCTR) | 24/03/2011 | 26/01/2011 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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 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 | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
610 | EUCTR2010-022366-27-GB (EUCTR) | 23/03/2011 | 30/11/2010 | BIPARK STUDY II | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic 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: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Phase 3 | Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India | ||
611 | 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 | ||
612 | 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 | |||
613 | 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 | ||
614 | 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 | |||
615 | 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 | ||
616 | 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 | ||
617 | EUCTR2009-013552-72-GB (EUCTR) | 07/03/2011 | 07/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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 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 | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
618 | 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 | ||
619 | 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 | |||
620 | 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 | ||
621 | EUCTR2010-021394-37-IT (EUCTR) | 01/03/2011 | 28/12/2011 | STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976 | STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976 | subjects with 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 Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine Trade Name: NEUPRO INN or Proposed INN: Rotigotine | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 345 | Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy | |||
622 | NCT01330290 (ClinicalTrials.gov) | March 2011 | 18/3/2011 | Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support | A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support | Idiopathic Parkinson's Disease | Drug: Neupro® | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 148 | N/A | Germany |
623 | 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 |
624 | 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 | ||
625 | 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 | |||
626 | 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 | ||
627 | 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 | ||
628 | 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 | ||
629 | 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 | |||
630 | 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 |
631 | 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 | ||
632 | 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 | |||
633 | 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 | ||
634 | 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 | ||
635 | 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 | |||
636 | EUCTR2009-013552-72-CZ (EUCTR) | 17/01/2011 | 28/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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 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 | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
637 | 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 | ||
638 | 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 | |||
639 | 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 | |||
640 | NCT01340885 (ClinicalTrials.gov) | January 2011 | 19/4/2011 | Cognitive Decline in Non-demented PD | Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study | Parkinson's Disease | Drug: Strattera;Drug: Exelon;Other: Placebo | Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | N/A | All | 9 | Phase 4 | United States |
641 | 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 | |||
642 | 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 | |||
643 | 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 | ||
644 | EUCTR2010-022366-27-EE (EUCTR) | 10/12/2010 | 03/11/2010 | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | 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-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II | Idiopathic Parkinson's Disease 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: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: Not yet available Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide | BIAL Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 405 | Czech Republic;Estonia;Belgium;United Kingdom | |||
645 | 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 | ||
646 | EUCTR2009-013552-72-IT (EUCTR) | 06/12/2010 | 04/11/2010 | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - 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 | 1000 | Phase 3 | Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden | ||
647 | 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 | ||
648 | EUCTR2009-013552-72-SE (EUCTR) | 02/12/2010 | 06/10/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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] | 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 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 | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
649 | 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 | ||
650 | NCT01244269 (ClinicalTrials.gov) | December 2010 | 18/11/2010 | The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease. | Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease. | Parkinson's Disease | Drug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20 | Laval University | Fonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research Center | Terminated | N/A | 75 Years | Both | 6 | Phase 4 | Canada |
651 | EUCTR2010-021860-13-LT (EUCTR) | 30/11/2010 | 28/09/2010 | 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 | 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 | 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] | 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® 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;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina | |||
652 | 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 | ||
653 | 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 | ||
654 | 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 |
655 | 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 |
656 | 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 | |||
657 | 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 | ||
658 | 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 | ||
659 | NCT01190553 (ClinicalTrials.gov) | November 2010 | 26/8/2010 | Pilot Study of Maintenance Therapy With Intravenous AMANTADINE | Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications | Parkinson Disease | Drug: Amantadine | Rabin Medical Center | NULL | Not yet recruiting | 30 Years | 80 Years | Both | 20 | N/A | NULL |
660 | 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 |
661 | NCT01270711 (ClinicalTrials.gov) | November 2010 | 9/12/2010 | Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) | Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) | Parkinson's Disease;Hyperprolactinemia | Drug: Study Drug | Pfizer | NULL | Completed | N/A | N/A | All | 22014 | N/A | NULL |
662 | EUCTR2009-013552-72-ES (EUCTR) | 26/10/2010 | 27/07/2010 | Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE | Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE | Enfermendad de Parkinson 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: SCH 420814 INN or Proposed INN: Preladenant Trade Name: Azilect Product Name: Azilect INN or Proposed INN: Rasagilina mesilato Other descriptive name: RASAGILINA MESILATO | Schering Corporation, división Schering-Plough Research | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden | ||
663 | 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 | ||
664 | EUCTR2009-013552-72-HU (EUCTR) | 21/10/2010 | 11/08/2010 | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy | A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy | 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 mesylate Other descriptive name: RASAGILINE MESYLATE | Schering-Plough Research Institute, a division of Schering Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden | ||
665 | 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 | ||
666 | 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 | |||
667 | 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 | ||
668 | 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 | |||
669 | 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 |
670 | 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 | |||
671 | 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 | ||
672 | 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 | ||
673 | 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 | |||
674 | EUCTR2009-013552-72-FI (EUCTR) | 07/09/2010 | 02/07/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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 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 | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | ||
675 | 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 |
676 | 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 | ||
677 | 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 | ||
678 | EUCTR2009-017182-38-ES (EUCTR) | 26/07/2010 | 25/05/2010 | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Enfermedad de Parkinson idiopática (parálisis agitante) 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 | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Estonia;Poland;Spain;Lithuania;Germany;Latvia | ||
679 | 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 |
680 | 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 | |||
681 | EUCTR2009-017182-38-LT (EUCTR) | 10/07/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with 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 Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
682 | EUCTR2009-017182-38-DE (EUCTR) | 09/07/2010 | 07/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with 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 | NULL | Not Recruiting | Female: yes Male: yes | 500 | Estonia;Spain;Poland;Lithuania;Latvia;Germany | |||
683 | EUCTR2009-017182-38-PL (EUCTR) | 07/07/2010 | 20/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with 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. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
684 | NCT01174810 (ClinicalTrials.gov) | July 2010 | 2/8/2010 | Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study | An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease. | Parkinson's Disease | Drug: Exenatide | University College, London | NULL | Active, not recruiting | 45 Years | 70 Years | Both | 40 | Phase 2 | United Kingdom |
685 | 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 | |||
686 | EUCTR2009-017182-38-LV (EUCTR) | 11/06/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with 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 Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
687 | 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 | |||
688 | 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 |
689 | 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 |
690 | EUCTR2010-019354-40-AT (EUCTR) | 26/05/2010 | 26/04/2010 | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Madopar INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE | Universitätsklinik für Neurologie Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | 15 | Austria | |||
691 | 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 | |||
692 | EUCTR2009-017182-38-EE (EUCTR) | 14/05/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with 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 Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
693 | JPRN-UMIN000003601 | 2010/05/01 | 18/05/2010 | Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients | Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients - ROPENT trial | Parkinson's disease | Increase dosage of ropinirole Addition of entacapone | Kansai Medical University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 30 | Not selected | Japan |
694 | EUCTR2009-018137-37-GB (EUCTR) | 14/04/2010 | 18/03/2010 | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Byetta 5 micrograms Product Name: Exenatide 5 micrograms Trade Name: Exenatide 10 micrograms Product Name: Exenatide 10 micrograms | University College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
695 | 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 |
696 | 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 | |||
697 | 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 | |||
698 | 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 |
699 | 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 |
700 | 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 | ||
701 | 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 | ||
702 | NCT01154166 (ClinicalTrials.gov) | February 15, 2010 | 29/6/2010 | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | Parkinson Disease | Drug: ReQuip PR;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 347 | Phase 3 | China |
703 | 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 | |||
704 | 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 | ||
705 | 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 | ||
706 | 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 | ||
707 | 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 | ||||
708 | 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 | ||
709 | EUCTR2009-012643-42-NL (EUCTR) | 06/01/2010 | 30/11/2009 | Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease | Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease | Parkinson's disease, in particular the symptom Freezing of Gait | Trade Name: Ritalin Product Name: Not applicable Product Code: Not applicable INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Other descriptive name: Ritalin | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
710 | JPRN-UMIN000007497 | 2010/01/01 | 14/03/2012 | Trial of molecular hydrogen water in Parkinson disease | Trial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease | Parkinson disease | The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 18 | Not applicable | Japan |
711 | JPRN-UMIN000003080 | 2010/01/01 | 30/01/2010 | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease - EDP2010 study | Parkinson's disease | Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks) Placebo | Clinical Research Center, Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | 40years-old | 75years-old | Male and Female | 30 | Not applicable | Japan |
712 | 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 |
713 | 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 | |||
714 | 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 | |||
715 | 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 | |||
716 | 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 | ||
717 | 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 | |||
718 | 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 | ||
719 | 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 | ||||
720 | 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 | ||||
721 | 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 | ||
722 | 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 | ||
723 | 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 | ||
724 | EUCTR2009-013670-41-CZ (EUCTR) | 18/11/2009 | 07/09/2009 | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Orfadin INN or Proposed INN: NITISINONE | Synosia Therapeutics AG | NULL | Not Recruiting | Female: yes Male: yes | 126 | Czech Republic;France | |||
725 | EUCTR2009-011093-15-DE (EUCTR) | 16/11/2009 | 23/09/2009 | The role of the neurotransmitters dopamine and acetylcholine in the interaction of selective attention and working memory. - Dopamine and Acetylcholine for Attention and Memory | The role of the neurotransmitters dopamine and acetylcholine in the interaction of selective attention and working memory. - Dopamine and Acetylcholine for Attention and Memory | Healthy volunteers MedDRA version: 12.0;Level: LLT;Classification code 10012271;Term: Dementia Alzheimer's type MedDRA version: 12.0;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Nacom INN or Proposed INN: LEVODOPA Other descriptive name: L-Dopa Trade Name: Reminyl INN or Proposed INN: GALANTAMINE Other descriptive name: Galantamine hydrobromide | Otto-von-Guericke University, Medical Faculty, Dpt. of Neurology | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Germany | ||
726 | 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 |
727 | 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 | ||
728 | EUCTR2009-013004-31-IT (EUCTR) | 02/11/2009 | 02/11/2009 | Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease | Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease | Patients with Parkinson`s diesease MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | INN or Proposed INN: Rasagiline INN or Proposed INN: Ropinirole | UNIVERSITA` DEGLI STUDI DI PARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
729 | NCT01007630 (ClinicalTrials.gov) | November 2009 | 3/11/2009 | A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients | A Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's Disease | Parkinson's Disease | Drug: Rasagiline;Drug: Placebo | The Parkinson's Institute | Teva Neuroscience, Inc. | Active, not recruiting | N/A | 90 Years | Both | 36 | Phase 4 | United States |
730 | NCT01532128 (ClinicalTrials.gov) | November 2009 | 23/1/2012 | Effect of BIA 9-1067 on Rasagiline Pharmacokinetics | Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects | Parkinson Disease | Drug: rasagiline;Drug: BIA 9-1067 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 24 | Phase 1 | France |
731 | NCT01532141 (ClinicalTrials.gov) | November 2009 | 23/1/2012 | Effect of Rasagiline on BIA 9-1067 Pharmacokinetics | Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Rasagiline | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 25 | Phase 1 | France |
732 | NCT01028209 (ClinicalTrials.gov) | November 2009 | 8/12/2009 | Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological Conditions | Alzheimer Disease;Parkinson Disease;Multiple Sclerosis | Drug: [18F] PBR06 | Institute for Neurodegenerative Disorders | NULL | Terminated | 18 Years | N/A | All | 12 | Phase 1 | United States | |
733 | NCT01052831 (ClinicalTrials.gov) | November 2009 | 15/1/2010 | Naltrexone for Impulse Control Disorders in Parkinson's Disease | Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease | Impulse Control Disorder;Parkinson Disease | Drug: Naltrexone;Drug: Placebo | University of Pennsylvania | Michael J. Fox Foundation for Parkinson's Research | Completed | 18 Years | 85 Years | All | 50 | Phase 4 | United States |
734 | 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 |
735 | 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 |
736 | 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 | |||
737 | 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 | ||
738 | EUCTR2009-013670-41-FR (EUCTR) | 16/10/2009 | 11/09/2009 | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Efficacy Study of SYN118 as Adjunctive Therapy in Subjects with Parkinson?s Disease | Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. MedDRA version: 12.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Orfadin INN or Proposed INN: NITISINONE | Synosia Therapeutics AG | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | France;Czech Republic | ||
739 | 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 | ||
740 | 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 | ||
741 | 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 | |||
742 | 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 | |||
743 | EUCTR2006-005186-18-NL (EUCTR) | 25/09/2009 | 29/05/2008 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
744 | 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 | |||
745 | 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 | |||
746 | 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 |
747 | 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 | ||
748 | 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 | ||
749 | 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 | |||
750 | 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 | ||
751 | 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 | ||
752 | 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 | ||
753 | 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 |
754 | 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 | |||
755 | 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 | |||
756 | 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 | ||
757 | 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 | |||
758 | 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 | ||
759 | 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 | |||
760 | 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 | |||
761 | 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 | |||
762 | 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 | ||
763 | 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 | ||
764 | 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 | ||
765 | 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 | ||
766 | 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 | |||
767 | 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 | |||
768 | 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 | |||
769 | 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 | |||
770 | EUCTR2006-000578-53-DE (EUCTR) | 08/05/2009 | 30/10/2008 | Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 70 | United States;Germany;New Zealand | |||
771 | 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 | |||
772 | 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 | |||
773 | 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 | ||
774 | 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 |
775 | 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 | ||||
776 | 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 | ||
777 | EUCTR2008-008210-38-FR (EUCTR) | 16/04/2009 | 19/03/2009 | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I | Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease MedDRA version: 9.1;Level: PT;Term: Parkinson's disease | Trade Name: EBIXA® Product Name: mémantine Trade Name: L-Dopa/ MODOPAR Product Name: L-Dopa | Chru de Lille | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 3 | France | ||
778 | EUCTR2007-004234-16-AT (EUCTR) | 14/04/2009 | 10/03/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
779 | 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 | ||
780 | 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 | ||||
781 | 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 | |||
782 | 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 | |||
783 | 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 | ||
784 | 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 | ||
785 | 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 |
786 | 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 | |||
787 | 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 | ||
788 | EUCTR2008-004447-11-GB (EUCTR) | 27/03/2009 | 07/01/2009 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;United Kingdom;Italy | ||
789 | 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 | ||
790 | 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 | ||
791 | 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 |
792 | EUCTR2006-005186-18-CZ (EUCTR) | 09/02/2009 | 21/11/2007 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand | |||
793 | EUCTR2008-006045-10-FR (EUCTR) | 06/02/2009 | 24/03/2009 | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | L’objectif thérapeutique principal dans la maladie de Parkinson est de contrôler les fluctuations motrices. Cependant des fluctuations non motrices (FNM) sont fréquemment observées et semblent corrélées à la sévérité de la maladie. La stabilité dans le temps de l’efficacité du traitement dopaminergique est le moyen le plus pertinent pour améliorer les fluctuations tant motrices que non motrices. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Apokinon | CHU de Rennes | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
794 | 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 |
795 | 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 | ||||
796 | 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 | ||||
797 | 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 | ||
798 | 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 | ||
799 | 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 | ||||
800 | 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 | ||||
801 | 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 | ||
802 | 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 | |||
803 | EUCTR2006-005186-18-GB (EUCTR) | 19/11/2008 | 27/06/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | 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;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | ||
804 | EUCTR2007-006721-27-GB (EUCTR) | 11/11/2008 | 25/02/2009 | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: CERE-120 Product Code: CERE-120 | Ceregene Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
805 | 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 | |||
806 | 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 | ||
807 | 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 |
808 | NCT00629161 (ClinicalTrials.gov) | November 2008 | 25/2/2008 | Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson Disease | Parkinson Disease | Drug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant);Drug: placebo | Fudan University | NULL | Recruiting | 50 Years | N/A | Both | 144 | Phase 2/Phase 3 | China | |
809 | EUCTR2007-006721-27-AT (EUCTR) | 20/10/2008 | 15/09/2008 | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. | idiopathic Parkinson's Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: CERE-120 Product Code: CERE-120 | Ceregene Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Austria;United Kingdom | ||
810 | EUCTR2007-004890-24-PT (EUCTR) | 07/10/2008 | 25/06/2008 | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN | Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy | Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets Product Code: JP-1730/F01 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets Product Code: JP-1730/F02 INN or Proposed INN: Fipamezole hydrochloride Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets Product Code: JP-1730/F03 INN or Proposed INN: Fipamezole hydrochloride | Juvantia Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Portugal;France | ||
811 | 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 | |||
812 | EUCTR2007-004235-37-IT (EUCTR) | 02/10/2008 | 28/11/2007 | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Patients with advanced idiopathic PD 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 ING. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
813 | 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 | |||
814 | EUCTR2006-005186-18-DE (EUCTR) | 30/09/2008 | 13/11/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. 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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | |||
815 | 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 | ||||
816 | 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 | |||
817 | 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 | |||
818 | 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 | ||
819 | NCT00758849 (ClinicalTrials.gov) | September 2008 | 24/9/2008 | Fipamezole in Neurogenic Orthostatic Hypotension | A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease | Symptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System Atrophy | Drug: Placebo;Drug: Fipamezole | Juvantia Pharma Ltd | Santhera Pharmaceuticals | Not yet recruiting | 30 Years | 80 Years | Both | 24 | Phase 2 | France;Portugal |
820 | 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 | |||
821 | 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 | |||
822 | NCT00601978 (ClinicalTrials.gov) | August 2008 | 11/1/2008 | Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off | Parkinson's Disease | Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone | Novartis Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | Both | 0 | Phase 4 | United States |
823 | 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 | ||
824 | 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 | |||
825 | 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 | ||
826 | 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 | |||
827 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
828 | 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 | ||
829 | 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 | ||
830 | 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 | |||
831 | EUCTR2007-004009-93-IT (EUCTR) | 20/05/2008 | 14/07/2008 | Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram | Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram | Depression, anxiety and ICD MedDRA version: 14.1;Level: SOC;Classification code 10037175;Term: Psychiatric disorders;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: CIPRALEX INN or Proposed INN: Escitalopram Trade Name: CIPRALEX INN or Proposed INN: Escitalopram | LUNDBECK ITALIA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
832 | 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 | ||
833 | NCT01238926 (ClinicalTrials.gov) | May 2008 | 9/11/2010 | Vitamin B6, B12, Folic Acid and Exercise in Parkinson's Disease | Effects of Vitamin Supplementation and Strength Training in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: PD vitamin supplementation;Other: PD exercise intervention;Other: PD vitamin + exercise | New York Institute of Technology | Stony Brook University | Active, not recruiting | 50 Years | 80 Years | Both | 40 | N/A | United States |
834 | 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 | |||
835 | EUCTR2007-004234-16-FI (EUCTR) | 16/04/2008 | 12/02/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 520 | Hungary;Finland;Czech Republic;Netherlands;France;Austria | |||
836 | 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 | |||
837 | 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 | ||
838 | NCT00651183 (ClinicalTrials.gov) | April 2008 | 31/3/2008 | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Parkinson Disease | Drug: Pramipexole immediate release | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 286 | Austria | |
839 | 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 |
840 | 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 | |||
841 | EUCTR2007-005033-11-DE (EUCTR) | 27/03/2008 | 04/01/2008 | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | Patients with Parkinson's Disease | Product Name: Levodopa-Carbidopa Multilayer Extended Release Tablet Product Code: Levodopa-Carbidopa XL tablet (M) INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet® CR Product Name: Sinemet CR INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
842 | 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 | |||
843 | 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 | ||
844 | EUCTR2007-004234-16-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
845 | 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 | ||
846 | EUCTR2006-005186-18-PT (EUCTR) | 07/03/2008 | 14/11/2007 | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
847 | NCT00642356 (ClinicalTrials.gov) | March 2008 | 19/3/2008 | Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis | NULL | Terminated | 30 Years | 85 Years | All | 14 | Phase 4 | United States |
848 | 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 |
849 | 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 | ||
850 | 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 | ||
851 | 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 | ||
852 | 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 | ||
853 | EUCTR2006-005186-18-IT (EUCTR) | 08/02/2008 | 14/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND | Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Duodopa gel intestinale INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals BV. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy | ||||
854 | EUCTR2007-002195-34-FR (EUCTR) | 04/02/2008 | 07/12/2007 | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. | Fatigue symptoms in Parkinson's disease. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DEBRUMYL Product Code: DC158AM INN or Proposed INN: Heptaminol hydrochloride INN or Proposed INN: Deanol pyroglutamate | PIERRE FABRE MEDICAMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
855 | NCT00855556 (ClinicalTrials.gov) | February 2008 | 25/2/2009 | Parkinson's Disease Genetics Database | Parkinson's Disease Genetics Database | Parkinson's Disease | Genetic: blood draw | North Shore Long Island Jewish Health System | NULL | Terminated | 18 Years | N/A | Both | 16 | N/A | United States |
856 | 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 | |
857 | 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 | ||
858 | 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 | ||||
859 | EUCTR2006-005186-18-ES (EUCTR) | 23/01/2008 | 29/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | ||
860 | 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 | |||
861 | 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 | ||
862 | 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 | |||
863 | EUCTR2007-004234-16-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
864 | 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 | ||
865 | 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 | ||
866 | 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 | ||
867 | EUCTR2007-004234-16-SK (EUCTR) | 14/01/2008 | 18/04/2008 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
868 | EUCTR2007-004234-16-FR (EUCTR) | 11/01/2008 | 19/11/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
869 | 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 |
870 | NCT00608231 (ClinicalTrials.gov) | January 2008 | 7/1/2008 | Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation | Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation | Parkinson's Disease;Essential Tremor;Dystonia | Drug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal Saline | Vanderbilt University | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2/Phase 3 | United States |
871 | 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 |
872 | NCT01628965 (ClinicalTrials.gov) | January 2008 | 25/6/2012 | A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 143 | Phase 2/Phase 3 | Japan |
873 | 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 | |||
874 | 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 | |||
875 | 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 | |||
876 | 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 | ||
877 | 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 | ||
878 | 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 | ||
879 | 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 | ||
880 | 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 | ||
881 | 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 | ||
882 | 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 | ||
883 | 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 | ||
884 | 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 | ||||
885 | NCT00537017 (ClinicalTrials.gov) | November 23, 2007 | 27/9/2007 | Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175) | A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175) | Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain Diseases | Drug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatments | Merck Sharp & Dohme Corp. | NULL | Completed | 30 Years | N/A | All | 140 | Phase 2 | Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States |
886 | EUCTR2006-005186-18-FI (EUCTR) | 16/11/2007 | 04/10/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
887 | 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 | |||
888 | EUCTR2007-002496-14-FI (EUCTR) | 05/11/2007 | 14/09/2007 | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product 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 Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
889 | NCT00610103 (ClinicalTrials.gov) | November 2007 | 22/1/2008 | Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy | A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease | Parkinson's Disease | Drug: apomorphine hydrochloride | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 16 | Phase 2 | Japan |
890 | NCT00584090 (ClinicalTrials.gov) | November 2007 | 21/12/2007 | Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease | Urinary Incontinence;Parkinson's Disease | Drug: Solifenacin Succinate (VESIcare);Drug: Placebo | University of South Florida | NULL | Withdrawn | 30 Years | 80 Years | Both | 0 | Phase 4 | United States | |
891 | 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 |
892 | 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 |
893 | 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 |
894 | 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 |
895 | EUCTR2007-004234-16-NL (EUCTR) | 29/10/2007 | 17/10/2007 | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). | Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III. 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 bv | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
896 | 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 | ||
897 | 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 | ||
898 | 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 | ||
899 | 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 | ||
900 | 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 | ||
901 | 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 | ||
902 | 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 | |||
903 | 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 | |||
904 | 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 |
905 | NCT00547911 (ClinicalTrials.gov) | October 2007 | 19/10/2007 | Augmenting Effects of L-DOPS With Carbidopa and Entacapone | L-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and Entacapone | Parkinson Disease;Multiple System Atrophy;Autonomic Nervous System Diseases | Drug: Droxidopa;Drug: Carbidopa;Drug: Entacapone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States |
906 | 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 | |||
907 | EUCTR2007-002899-34-GB (EUCTR) | 18/09/2007 | 26/06/2007 | Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease | Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease | Cognitive impairment in Parkinson's Disease | Product Name: Sage leaf | Newcastle Upon tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
908 | 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 | |||
909 | 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 | |||
910 | 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 | |||
911 | 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 |
912 | NCT00537485 (ClinicalTrials.gov) | September 2007 | 27/9/2007 | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa | Early Parkinson's Disease | Drug: SPM 962;Drug: placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 180 | Phase 2/Phase 3 | Japan |
913 | 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 | ||
914 | 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 | ||
915 | 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 | |||
916 | 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 | |||
917 | 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 | ||
918 | 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 | |||
919 | 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 | |||
920 | 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 | ||
921 | 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 | ||
922 | 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 |
923 | 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 | ||
924 | 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 | |||
925 | 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 | ||
926 | 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 | ||
927 | 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 | ||
928 | 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 | ||
929 | 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 | ||
930 | EUCTR2006-005438-19-DE (EUCTR) | 12/06/2007 | 28/03/2007 | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS | idiopathic Parkinson´s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Neupro 2 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 4 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 6 mg/24 h transdermal patch INN or Proposed INN: Rotigotine Trade Name: Neupro 8 mg/24 h transdermal patch INN or Proposed INN: Rotigotine | SCHWARZ PHARMA Deutschland GmbH | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
931 | 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 | ||
932 | 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 | |||
933 | 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 |
934 | 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 | ||
935 | 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 | ||
936 | 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 | ||
937 | 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 | ||
938 | 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 | ||
939 | 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 | ||
940 | 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 | ||
941 | 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 | ||
942 | 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 | ||
943 | 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 | ||
944 | 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 | ||
945 | 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 | ||
946 | 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 |
947 | 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 | |||
948 | 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 | |||
949 | 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 | |||
950 | 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 | ||
951 | EUCTR2007-000307-15-IT (EUCTR) | 24/04/2007 | 23/08/2007 | Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. | Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. | Psicosi associata al morbo di Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: Melperon INN or Proposed INN: melperon | OVATION PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
952 | 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 | |||
953 | 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 | ||
954 | 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 | ||
955 | 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 | |||
956 | NCT00623363 (ClinicalTrials.gov) | April 2007 | 2/1/2008 | Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease | Parkinson's Disease | Drug: piclozotan;Drug: 0.9% sodium chloride (normal saline) | Asubio Pharmaceuticals, Inc. | NULL | Completed | 40 Years | 85 Years | Both | 27 | Phase 2 | United States;Guatemala;Romania | |
957 | 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 | |||
958 | 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 | ||
959 | 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 | |||
960 | 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 | ||
961 | 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 | |||
962 | 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 | |||
963 | 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 | |||
964 | 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 | |||
965 | 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 | |||
966 | 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 | |||
967 | 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 | ||
968 | 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 | |||
969 | 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 |
970 | 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 | |||
971 | 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 | |||
972 | EUCTR2005-002654-21-NO (EUCTR) | 28/12/2006 | 06/11/2006 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinalgel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 75 | Norway;Sweden | |||
973 | 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 | |||
974 | 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 | ||
975 | EUCTR2005-000314-12-DE (EUCTR) | 19/12/2006 | 25/01/2007 | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil Product Name: S90049 Product Code: S90049 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
976 | 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 | ||
977 | 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 | ||
978 | 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 | |||
979 | 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 | ||
980 | 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 | |||
981 | 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 | ||
982 | 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 | |||
983 | 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 | |||
984 | EUCTR2005-002038-36-FR (EUCTR) | 01/12/2006 | 24/08/2010 | 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 | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE 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 | ||
985 | NCT00853879 (ClinicalTrials.gov) | December 2006 | 26/2/2009 | An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease | An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease | Parkinson's Disease | Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, Placebo | North Shore Long Island Jewish Health System | NULL | Terminated | 30 Years | N/A | Both | 150 | N/A | United States |
986 | EUCTR2005-002038-36-DE (EUCTR) | 29/11/2006 | 19/01/2007 | 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 | Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE Product Name: Memantine INN or Proposed INN: MEMANTINE HYDROCHLORIDE | H. Lundbeck A/S | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;France;Spain;Italy;Greece;Austria | |||
987 | 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 |
988 | 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 | ||
989 | 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 | ||
990 | 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 | ||||
991 | 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 | |||
992 | 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 | |||
993 | 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 | |||
994 | 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 | |||
995 | 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 | |||
996 | EUCTR2006-004582-33-GB (EUCTR) | 03/11/2006 | 23/01/2012 | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease | Product Name: Apomorphine hydrochloride Product Code: VR040 | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United Kingdom | ||
997 | 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 | |||
998 | 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 | |||
999 | 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 |
1000 | 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 |
1001 | 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 |
1002 | 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 |
1003 | 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 |
1004 | NCT00397696 (ClinicalTrials.gov) | November 2006 | 7/11/2006 | Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease | Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects | Parkinson Disease | Drug: [123I] 5-IA | Institute for Neurodegenerative Disorders | Department of Defense | Completed | 21 Years | N/A | Both | 9 | Phase 2 | United States |
1005 | 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 |
1006 | NCT00397228 (ClinicalTrials.gov) | November 2006 | 6/11/2006 | ALTROPANE® SPECT Imaging in Patients With Parkinson Disease | Optimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson Disease | Parkinson Disease | Drug: ALTROPANE® | Molecular NeuroImaging | Institute for Neurodegenerative Disorders | Completed | 30 Years | N/A | Both | 27 | Phase 2 | United States |
1007 | NCT00402233 (ClinicalTrials.gov) | November 2006 | 19/11/2006 | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients | A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 31 Years | N/A | All | 312 | Phase 4 | United States |
1008 | 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 | ||
1009 | 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 | |||
1010 | 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 | |||
1011 | 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 | |||
1012 | 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 | ||
1013 | 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 | |||
1014 | 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 |
1015 | NCT00399477 (ClinicalTrials.gov) | October 2006 | 10/11/2006 | A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease | Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) | Parkinson's Disease | Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip | Teva Neuroscience, Inc. | NULL | Completed | 30 Years | N/A | Both | 200 | Phase 4 | United States |
1016 | 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 | |||
1017 | EUCTR2005-002038-36-AT (EUCTR) | 22/09/2006 | 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 | Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE Trade Name: Ebixa Product Name: Ebixa INN or Proposed INN: MEMANTINE HYDROCHLORIDE 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 | Germany;United Kingdom;France;Spain;Italy;Greece;Austria | |||
1018 | 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 | |||
1019 | 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 | |||
1020 | 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 | |||
1021 | 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 | ||
1022 | 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 | |||
1023 | 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 | ||
1024 | EUCTR2005-005423-34-HU (EUCTR) | 04/09/2006 | 05/07/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
1025 | 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 |
1026 | 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 | |||
1027 | 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 | |||
1028 | 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 | |||
1029 | 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 | |||
1030 | 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 | |||
1031 | 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 | |||
1032 | 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 | ||
1033 | 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 | |||||
1034 | 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 | |||
1035 | 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 | |||
1036 | 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 |
1037 | 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 | ||
1038 | 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 | |||
1039 | NCT00331149 (ClinicalTrials.gov) | June 20, 2006 | 26/5/2006 | A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa. | Parkinson Disease | Drug: Ropinirole prolonged release;Drug: ropinirole immediate release | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 343 | Phase 3 | Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
1040 | 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 | ||
1041 | EUCTR2005-005423-34-DE (EUCTR) | 19/06/2006 | 02/03/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | Parkinson's disease | Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
1042 | 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 | |||
1043 | 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 | ||
1044 | 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 | |||
1045 | EUCTR2005-005423-34-ES (EUCTR) | 19/05/2006 | 29/03/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | Parkinson's disease | Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
1046 | 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 | ||
1047 | 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 | ||
1048 | EUCTR2005-005423-34-GB (EUCTR) | 11/05/2006 | 17/03/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | Parkinson's disease | Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
1049 | 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 | |||
1050 | EUCTR2005-005423-34-IT (EUCTR) | 08/05/2006 | 03/10/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND | Parkinson disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 0,25MG INN or Proposed INN: Ropinirole Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Product Name: ropinirole PR/XR tablets Product Code: SKF-101468A INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 0,5MG INN or Proposed INN: Ropinirole Trade Name: REQUIP*21CPR 1MG INN or Proposed INN: Ropinirole | GlaxoSmithKline R D | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
1051 | NCT00291733 (ClinicalTrials.gov) | May 2006 | 14/2/2006 | Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease | Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial | Levodopa Induced Dyskinesia | Drug: Levetiracetam;Drug: Placebo | 1st Hospital of Social Security Services | UCB Pharma | Active, not recruiting | 30 Years | 80 Years | Both | 50 | Phase 2 | Greece |
1052 | 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 | ||
1053 | 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 | |||
1054 | EUCTR2005-005423-34-CZ (EUCTR) | 20/04/2006 | 03/03/2006 | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. | Parkinson's disease | Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole PR/XR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets INN or Proposed INN: Ropinirole Other descriptive name: Ropinirole hydrochloride Product Name: Ropinirole IR Tablets | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy | |||
1055 | 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 | |||
1056 | 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 | ||
1057 | NCT00646204 (ClinicalTrials.gov) | April 2006 | 28/12/2007 | Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease | A 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE | Parkinson's Disease | Drug: Memantine;Drug: placebo | Baylor College of Medicine | Forest Laboratories | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | United States |
1058 | 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 |
1059 | 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 | |||
1060 | 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 | ||
1061 | EUCTR2005-003788-22-SE (EUCTR) | 03/03/2006 | 19/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | ||
1062 | 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 | |||
1063 | 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 | ||
1064 | NCT00141518 (ClinicalTrials.gov) | March 2006 | 30/8/2005 | Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact | A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia | Advanced Idiopathic Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube) | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 99 Years | All | 77 | Phase 4 | Norway;Sweden |
1065 | EUCTR2005-003788-22-AT (EUCTR) | 22/02/2006 | 18/01/2006 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Austria GmbH | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
1066 | 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 | ||||
1067 | EUCTR2005-003788-22-ES (EUCTR) | 09/02/2006 | 28/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Mirapexin / Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Mirapexin/Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim España S.A. | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
1068 | 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 | ||
1069 | 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 | |||
1070 | 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 | |||
1071 | 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 | |||
1072 | 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 | |||
1073 | EUCTR2005-003788-22-DE (EUCTR) | 01/02/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | 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 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 | 354 | Phase 1 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
1074 | NCT00630500 (ClinicalTrials.gov) | February 2006 | 27/2/2008 | Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB) | A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies | Dementia Associated With Parkinson's Disease;Dementia With Lewy Bodies | Drug: Memantine;Drug: Placebo | Helse Stavanger HF | King's College London;Lund University | Completed | N/A | N/A | Both | 75 | Phase 2 | Norway;Sweden;United Kingdom |
1075 | 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 | |||
1076 | 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 | |||
1077 | 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 | |||
1078 | EUCTR2005-003788-22-FI (EUCTR) | 17/01/2006 | 07/12/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Finland Ky | Not Recruiting | Female: yes Male: yes | 318 | Phase 1 | Finland;Germany;United Kingdom;Spain;Italy;Sweden | |||
1079 | EUCTR2005-003788-22-GB (EUCTR) | 06/01/2006 | 11/11/2005 | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. | A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms | Trade Name: Sifrol Product Name: Sifrol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole Trade Name: Sifrol Product Name: Sifol Product Code: SND 919 CL2 Y INN or Proposed INN: Pramipexole | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 318 | Phase 4 | Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
1080 | NCT00272688 (ClinicalTrials.gov) | January 2006 | 6/1/2006 | Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit | Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation | Parkinson Disease | Drug: Levodopa (drug), intraduodenal administration | University Hospital, Akershus | Solvay Pharmaceuticals | Completed | N/A | N/A | Both | 10 | Phase 4 | Norway |
1081 | 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 | ||
1082 | 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 | |||
1083 | 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 | |||
1084 | 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 | ||
1085 | 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 | |||
1086 | 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 | |||
1087 | 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 |
1088 | 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 |
1089 | NCT00260793 (ClinicalTrials.gov) | November 2005 | 1/12/2005 | Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease | Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease | Parkinson's Disease | Drug: Ropinirole Hydrochloride | Agarwal, Pinky, M.D. | Colorado Neurology;GlaxoSmithKline | Recruiting | 25 Years | N/A | Both | 20 | Phase 3 | United States |
1090 | NCT00250393 (ClinicalTrials.gov) | November 2005 | 4/11/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease | Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 64 | Phase 2 | Japan |
1091 | 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 | ||
1092 | EUCTR2005-000314-12-ES (EUCTR) | 14/10/2005 | 08/09/2005 | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI | Parkinson's Disease aggravated MedDRA version: 7.0;Level: LLT;Classification code 10034006 | Product Name: piribedil Product Code: S 90049 - F36 INN or Proposed INN: piribedil Product Name: piribedil Product Code: S 90049 - F38 INN or Proposed INN: piribedil | Institut de Recherches Internationales Servier | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Spain;Germany | ||
1093 | NCT00199381 (ClinicalTrials.gov) | October 2005 | 12/9/2005 | An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001 | An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline. | Parkinson's Disease | Drug: Istradefylline | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Terminated | 30 Years | N/A | All | 504 | Phase 3 | United States |
1094 | 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 | |||
1095 | 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 | |||
1096 | 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 | ||
1097 | 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 | ||
1098 | 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 | |||
1099 | 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 | |||
1100 | EUCTR2005-002654-21-SE (EUCTR) | 08/08/2005 | 14/06/2005 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinal gel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
1101 | 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 | |||
1102 | 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 |
1103 | 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 | ||
1104 | EUCTR2004-001485-41-GB (EUCTR) | 26/07/2005 | 21/06/2005 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaser Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I] | Institute for Neurodegenerative Disorders | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Spain | |||
1105 | EUCTR2004-002844-93-AT (EUCTR) | 20/07/2005 | 15/06/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom | |||
1106 | 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 | ||
1107 | 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 | |||
1108 | 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 | ||||
1109 | 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 | ||
1110 | EUCTR2004-002844-93-IT (EUCTR) | 06/07/2005 | 21/09/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | KYOWA HAKKO UK LTD | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | |||||
1111 | 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 |
1112 | 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 | ||
1113 | 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 | |||
1114 | 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 | |||
1115 | 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 | ||
1116 | EUCTR2004-002608-13-GB (EUCTR) | 16/05/2005 | 19/04/2005 | Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease | Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease | Parkinson's Disease with psychosis | Trade Name: Seroquel Product Name: Seroquel Trade Name: Seroquel Product Name: Seroquel | King’s College London & King’s College Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
1117 | 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 | ||
1118 | 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 | ||
1119 | 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 | |||
1120 | EUCTR2004-002844-93-ES (EUCTR) | 01/04/2005 | 04/11/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
1121 | 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 | ||
1122 | EUCTR2004-002844-93-EE (EUCTR) | 08/03/2005 | 07/03/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
1123 | 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 | ||
1124 | EUCTR2004-002844-93-LT (EUCTR) | 08/02/2005 | 03/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
1125 | 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 | ||
1126 | 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 | ||
1127 | 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 | |||
1128 | EUCTR2004-002844-93-GB (EUCTR) | 01/02/2005 | 23/02/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain | ||||
1129 | EUCTR2004-002844-93-LV (EUCTR) | 28/01/2005 | 31/01/2005 | A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) 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 | Kyowa Hakko U.K. Limited | NULL | Not Recruiting | Female: yes Male: yes | 1175 | United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania | ||||
1130 | 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 | ||
1131 | 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 |
1132 | 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 | ||
1133 | 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 | ||
1134 | 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 | ||
1135 | 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 | |||
1136 | 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 | ||
1137 | 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 | |||
1138 | 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 | |||
1139 | 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 | |||
1140 | 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 | |||
1141 | 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 | ||
1142 | 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 | |||
1143 | 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 | ||
1144 | NCT01518309 (ClinicalTrials.gov) | November 17, 2004 | 16/12/2008 | An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients | An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients | Parkinson's Disease Psychosis | Drug: pimavanserin tartrate (ACP-103) | ACADIA Pharmaceuticals Inc. | NULL | Completed | N/A | N/A | All | 39 | Phase 2 | United States |
1145 | 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 | |||
1146 | 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 | ||
1147 | 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 |
1148 | 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 |
1149 | 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 |
1150 | 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 |
1151 | 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 | |
1152 | NCT00229736 (ClinicalTrials.gov) | November 2004 | 28/9/2005 | A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease | A Phase1 Open Label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase (AAV-hAADC-2) in Subjects With Parkinson's Disease [AAV-hAADC-2-003] | Parkinson's Disease | Genetic: AAV-hAADC-2 | Genzyme, a Sanofi Company | NULL | Completed | 40 Years | 75 Years | Both | 10 | Phase 1 | United States |
1153 | 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 | |||
1154 | 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 | ||||
1155 | 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 | |||
1156 | 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 | ||
1157 | 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 | ||
1158 | 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 | ||
1159 | 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 | |||
1160 | 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 | |||
1161 | 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 | |||
1162 | 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 |
1163 | 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 |
1164 | 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 |
1165 | 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 | ||
1166 | NCT00174239 (ClinicalTrials.gov) | July 2004 | 9/9/2005 | Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease. | A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients. | Parkinson Disease | Drug: cabergoline;Drug: controlled-release levodopa / carbidopa | Pfizer | NULL | Terminated | 18 Years | 80 Years | Both | 220 | Phase 4 | Australia;Italy;Spain;United Kingdom |
1167 | 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 | ||
1168 | NCT00211588 (ClinicalTrials.gov) | June 2004 | 13/9/2005 | Galantamine Executive Function in Parkinson's Disease | Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease | Parkinson's Disease | Drug: galantamine | Memorial Hospital of Rhode Island | Ortho-McNeil Neurologics, Inc. | Active, not recruiting | 60 Years | 85 Years | Both | 90 | N/A | United States |
1169 | NCT00244387 (ClinicalTrials.gov) | March 2004 | 24/10/2005 | Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | A Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa | Parkinson Disease, Idiopathic | Drug: SPM 962 | UCB Pharma | NULL | Completed | 30 Years | N/A | Both | 506 | Phase 3 | Germany |
1170 | 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 |
1171 | 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 |
1172 | NCT00381472 (ClinicalTrials.gov) | June 2003 | 26/9/2006 | Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 393 | Phase 3 | United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain |
1173 | NCT00062738 (ClinicalTrials.gov) | June 2003 | 12/6/2003 | Treatment of Depression in Parkinson's Disease Trial | Treatment of Depression in Patients With Parkinson's Disease | Parkinson Disease;Depression | Drug: paroxetine;Drug: Nortriptyline;Other: placebo | Rutgers, The State University of New Jersey | GlaxoSmithKline | Completed | 35 Years | 80 Years | All | 52 | Phase 2 | United States |
1174 | 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 |
1175 | 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 |
1176 | 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 |
1177 | NCT00037830 (ClinicalTrials.gov) | November 1999 | 22/5/2002 | GM1 Ganglioside Effects on Parkinson's Disease | The Study of GM1 Ganglioside, A Potential New Parkinson's Disease Medication | Parkinson Disease | Drug: GM1 ganglioside;Drug: Placebo | Thomas Jefferson University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 39 Years | 85 Years | All | 94 | Phase 2 | United States |
1178 | 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 |
1179 | 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 |
1180 | 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 | |
1181 | 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 | ||||
1182 | 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 | |||
1183 | EUCTR2009-013552-72-DE (EUCTR) | 23/08/2010 | A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664) | A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy | 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] | 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 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 | 1000 | Phase 3 | United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden | |||
1184 | 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 | ||||
1185 | 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 | ||||
1186 | EUCTR2008-004447-11-DE (EUCTR) | 17/10/2008 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;Italy;United Kingdom | |||
1187 | 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 | |||||
1188 | 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 |