6. Parkinson disease Clinical trials / Disease details


Clinical trials : 2,298 Drugs : 2,202 - (DrugBank : 350) / Drug target genes : 188 - Drug target pathways : 202

  
1165 trials found
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PhaseCountries
1NCT04147949
(ClinicalTrials.gov)
August 202227/10/2019AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiaRandomized, 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 DyskinesiaParkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic UseDrug: AV-101;Drug: PlaceboVistaGen Therapeutics, Inc.NULLNot yet recruiting30 Years80 YearsAll20Phase 2NULL
2NCT05094011
(ClinicalTrials.gov)
May 1, 202220/7/2021Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's DiseaseA 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 DiseaseIdiopathic Parkinson's DiseaseBiological: Aadipose-Derived Mesenchymal Stem CellsTaiwan Mitochondrion Applied Technology Co., Ltd.NULLNot yet recruiting45 Years70 YearsAll9Phase 1NULL
3NCT04373317
(ClinicalTrials.gov)
May 1, 202229/4/2020Pimavanserin vs. Quetiapine for the Treatment Parkinson's PsychosisCSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)Parkinson's Disease PsychosisDrug: Pimavanserin;Drug: QuetiapineVA Office of Research and DevelopmentNULLNot yet recruiting40 YearsN/AAll358Phase 4United States
4NCT05197439
(ClinicalTrials.gov)
April 1, 20225/1/2022Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's DiseaseEffect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled TrialDexmedetomidine;Postoperative Delirium;Deep Brain StimulationDrug: Dexmedetomidine;Drug: 0.9% salineBeijing Tiantan HospitalNULLNot yet recruiting60 YearsN/AAll182N/AChina
5NCT05258071
(ClinicalTrials.gov)
March 202210/2/2022A Clinical Study Evaluating Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's Disease (PD)A Randomised, Placebo-controlled, Multicentre Phase IIb Study Evaluating the Efficacy of Pirepemat on Falls Frequency in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Pirepemat;Drug: PlaceboIntegrative Research Laboratories ABNULLNot yet recruiting55 Years85 YearsAll165Phase 2NULL
6NCT05266417
(ClinicalTrials.gov)
February 7, 202223/2/2022Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's DiseaseA 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 DiseaseDrug: INS-GSH;Drug: Matched PlacebosGateway Institute for Brain ResearchNULLRecruiting30 Years85 YearsAll56Phase 2United States
7NCT05103618
(ClinicalTrials.gov)
February 1, 202221/10/2021Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPAEvaluating the Physiological and Psychological Effects of a Novel Meditation Technique on Cerebral Activity Measured With Functional Magnetic Resonance Imaging(fMRI) and F-18 Fluorodopa PET ImagingParkinson Disease;Idiopathic Parkinson DiseaseDrug: [F-18] Fluorodopa Positron Emission Tomography;Behavioral: OM MeditationAndrew NewbergNULLNot yet recruiting25 YearsN/AAll80Phase 2United States
8EUCTR2021-005024-37-NL
(EUCTR)
24/01/202219/01/2022Evaluation of a novel PET tracer [18F]MC225 to measure the function of P-glycoprotein, a transporter at the blood brain barrier, in neurodegenerative diseaseEvaluation 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 GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Netherlands
9NCT04952194
(ClinicalTrials.gov)
January 1, 20223/6/2021Clinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseClinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseParkinson DiseaseDrug: Stalevo;Drug: Carbidopa and Levodopa Controlled Release TabletsSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLNot yet recruiting30 Years70 YearsAll180Phase 4NULL
10NCT05152394
(ClinicalTrials.gov)
January 202229/11/2021Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Parkinson's DiseaseSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Parkinson's DiseaseParkinson DiseaseBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLNot yet recruitingN/AN/AAll20Phase 1Antigua and Barbuda
11NCT05001217
(ClinicalTrials.gov)
December 1, 20217/7/2021Chinese Herbal Medicine Treatment Based on Subgroup Differentiation as Adjunct Therapy for Parkinson's Disease: a Pilot add-on, Randomised, Controlled, Pragmatic Clinical TrialChinese Herbal Medicine Treatment Based on Subgroup Differentiation as Adjunct Therapy for Parkinson's DiseaseParkinson DiseaseDrug: Conventional medication;Drug: Chinese herbal medicine treatmentHong Kong Baptist UniversityChinese University of Hong KongNot yet recruiting18 Years80 YearsAll160Phase 2/Phase 3NULL
12NCT03903549
(ClinicalTrials.gov)
December 20213/4/2019Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy VolunteersA Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2)Parkinson DiseaseDrug: [18F]P17-059Five Eleven Pharma, Inc.NULLNot yet recruiting45 Years90 YearsAll26Phase 1United States
13NCT03446807
(ClinicalTrials.gov)
December 202120/2/2018Safety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismSafety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismParkinson Disease;Multiple System Atrophy;Progressive Supranuclear PalsyDrug: Droxidopa;Drug: Placebo Oral TabletLoma Linda UniversityH. Lundbeck A/SNot yet recruiting50 YearsN/AAll32Phase 2United States
14NCT04944017
(ClinicalTrials.gov)
November 23, 202122/6/2021Ketamine for the Treatment of Depression in Parkinson's DiseaseKetamine for the Treatment of Depression in Parkinson's DiseaseParkinson's Disease;DepressionDrug: Ketamine Infusion;Other: Placebo - Saline InfusionYale UniversityFox (Michael J.) Foundation for Parkinson's ResearchRecruiting40 Years70 YearsAll56Phase 2United States
15NCT05109364
(ClinicalTrials.gov)
November 23, 202113/10/2021Terazosin and Parkinson's Disease Extension StudyThe Effect of alpha1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up StudySymptomatic Parkinson Disease;REM Sleep Behavior Disorder;Pre-motor Parkinson's DiseaseDrug: Terazosin therapyCedars-Sinai Medical CenterNULLNot yet recruiting25 Years85 YearsAll15Phase 2NULL
16NCT05164783
(ClinicalTrials.gov)
November 23, 202128/10/2021Multicenter Implementation of E-monitoring in Parkinson's DiseaseMulticenter Implementation of E-monitoring in Parkinson's DiseaseParkinson DiseaseCombination Product: Sanacoach Parkinson (SCP)Zuyderland Medisch CentrumAbbVieRecruiting30 YearsN/AAll450N/ANetherlands
17NCT05173701
(ClinicalTrials.gov)
November 22, 20218/11/2021Effects of Probiotics on Peripheral Immunity in Parkinson's DiseaseEffects of Probiotics on Peripheral Immunity in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Probiotics;Dietary Supplement: PlaceboFranca MarinoUniversità degli Studi del Piemonte Orientale Amedeo Avogadro;Università degli Studi dell'InsubriaEnrolling by invitationN/AN/AAll88N/AItaly
18NCT05056194
(ClinicalTrials.gov)
November 1, 202117/9/2021Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease StudyA 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 DiseaseParkinson Disease;Excessive Daytime SomnolenceDrug: Valiloxybate;Other: PlaceboXWPharmaNULLNot yet recruiting40 Years75 YearsAll70Phase 2NULL
19NCT04983290
(ClinicalTrials.gov)
November 1, 20219/6/2021Outcomes to the Nutritional Need of Patients With Parkinson's DiseaseClinical 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 DiseaseDeglutition Disorders;Parkinson Disease;Nursing;Quality of LifeDietary Supplement: weancare-domusMilko ZaniniAzienda Sanitaria Locale 3 GenoveseNot yet recruiting18 YearsN/AAll140N/AItaly
20NCT04990284
(ClinicalTrials.gov)
November 202127/7/2021eArly 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 DiseaseDrug: Opicapone;Drug: L-DOPA/DDCIBial - Portela C S.A.NULLNot yet recruiting30 YearsN/AAll100Phase 4NULL
21NCT05083260
(ClinicalTrials.gov)
November 202123/9/2021NE3107 Activity and Safety in Patients With Parkinson's Disease Using LevodopaA Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107Parkinson DiseaseDrug: NE3107;Drug: placeboBioVie Inc.NULLNot yet recruiting30 Years75 YearsAll40Phase 1/Phase 2NULL
22NCT05128175
(ClinicalTrials.gov)
October 29, 202127/10/2021Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed ConditionsAn 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 ConditionsParkinson DiseaseDrug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsShanghai WD Pharmaceutical Co., Ltd.NULLRecruiting18 Years45 YearsAll15Phase 1India
23NCT04346394
(ClinicalTrials.gov)
October 11, 202110/3/2020The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's DiseaseThe Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor SymptomsParkinson DiseaseDrug: Yohimbine HClNathaniel M. RobbinsNULLRecruitingN/AN/AAll22Early Phase 1United States
24NCT05084365
(ClinicalTrials.gov)
October 10, 20217/10/2021A 6-month Study to Evaluate Sulforaphane Effects in PD PatientsA 6-month Study to Evaluate Sulforaphane Effects in Treatment of Cognition Impairment of PD PatientsParkinson DiseaseDrug: Sulforaphane;Drug: PlaceboCentral South UniversityNULLNot yet recruiting40 Years75 YearsAll100Phase 2NULL
25NCT04912115
(ClinicalTrials.gov)
October 5, 202125/5/2021Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced DyskinesiaA Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo- Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa- Induced Dyskinesia in Subjects With Parkinson's DiseaseDyskinesias;Movement Disorders;Central Nervous System Diseases;Nervous System Diseases;Neurologic ManifestationsDrug: Ketamine;Drug: MidazolamPharmaTher Inc.NULLActive, not recruiting30 Years85 YearsAll30Phase 2United States
26NCT04265209
(ClinicalTrials.gov)
October 20216/2/2020[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential TremorNon-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 TremorDrug: SPECT;Drug: PETZionexaNULLNot yet recruiting35 Years80 YearsAll112Phase 3NULL
27NCT04933513
(ClinicalTrials.gov)
September 30, 20218/6/2021Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's DiseaseDevelopment and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)Parkinson's DiseaseBehavioral: pre DBS patients responding to the DBS-PS scaleCentral Hospital, Nancy, FranceUniversity Hospital, Bordeaux;Poitiers University Hospital;Assistance Publique - Hôpitaux de Paris;University Hospital, LilleNot yet recruiting18 YearsN/AAll22France
28NCT05106504
(ClinicalTrials.gov)
September 2, 202116/10/2021Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's DiseaseEffect of Medical Cannabis for Non-motor Symptoms of Parkinson's DiseaseBladder, Overactive;Parkinson DiseaseDrug: Medical CannabisSheba Medical CenterNULLRecruiting18 Years80 YearsAll100Israel
29NCT04879134
(ClinicalTrials.gov)
September 20214/5/2021Apomorphine Effects on Pain in Parkinson's DiseaseApomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over StudyParkinson DiseaseDrug: Apomorphine Injectable Solution;Drug: PlaceboUniversity of CalgaryPaladin Labs Inc.Not yet recruiting18 Years70 YearsAll40Phase 2/Phase 3Canada
30NCT04772378
(ClinicalTrials.gov)
July 14, 202123/2/2021Individual Patient Expanded Access IND of HB-adMSCs for the Treatment of Parkinson's DiseaseIndividual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Parkinson's DiseaseParkinson DiseaseBiological: HB-adMSCsHope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer available18 YearsN/AMaleUnited States
31NCT04468919
(ClinicalTrials.gov)
July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
32NCT04928287
(ClinicalTrials.gov)
June 28, 202126/5/2021Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's DiseaseParkinson DiseaseBiological: HB-adMSCs;Other: PlaceboHope Biosciences Stem Cell Research FoundationHope BiosciencesActive, not recruiting18 Years75 YearsAll24Phase 2United States
33NCT04863118
(ClinicalTrials.gov)
June 1, 202111/4/2021Acute Effects of Strength Training and High Intensity Training on Functional and Biochemical Measurements of Individuals With Parkinson's Disease in Different Environments and DepthsAcute Effects of Strength Training in Shallow Water and Dry Land and High-intensity Training in Shallow and Deep Water, on Functional Measures and Biochemistries of Individuals With Parkinson's DiseaseParkinson Disease and HydrotherapyOther: Strength training in shallow water and dry land;Other: High-intensity training in shallow and deep waterFederal University of Health Science of Porto AlegreNULLNot yet recruiting50 Years70 YearsAll60N/ANULL
34NCT03309514
(ClinicalTrials.gov)
June 202110/10/2017Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's DiseaseClinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's DiseaseParkinson's DiseaseBiological: Intracerebral microinjectionsNeuroGenerationNULLNot yet recruiting35 Years85 YearsAll12Phase 1/Phase 2NULL
35NCT04867551
(ClinicalTrials.gov)
May 15, 202127/4/2021A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's DiseaseA Phase II Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: KDT-3594Kissei Pharmaceutical Co., Ltd.NULLActive, not recruiting20 Years79 YearsAll6Phase 2Japan
36EUCTR2021-000826-89-FR
(EUCTR)
23/04/202125/03/2021Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitementEtude 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 RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 4France
37EUCTR2021-000867-65-DE
(EUCTR)
19/04/202116/03/2021Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed rotigotine-containing transdermal 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 AGNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
38NCT04810104
(ClinicalTrials.gov)
April 202115/3/2021Parkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist DrugParkinson's Disease With Mild Cognitive Impairment Treated With Nicotinic Agonist DrugParkinson Disease;Mild Cognitive ImpairmentDrug: AZD0328;Drug: PlaceboKing's College LondonHelse 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 InitiativeNot yet recruiting50 Years80 YearsAll160Phase 2Norway
39EUCTR2019-000247-27-FR
(EUCTR)
31/03/202105/03/2019Study 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
ZIONEXANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 3France
40JPRN-jRCTs051200160
24/03/202124/03/2021ZEAL studyZonisamide 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 administrationHiroshi KataokaNULLRecruiting>= 41age oldNot applicableBoth70Phase 2-3Japan
41NCT04665869
(ClinicalTrials.gov)
March 15, 20217/12/2020Long-term Effects of Combined Balance and Brisk Walking in Parkinson's DiseaseLong-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled TrialParkinson DiseaseBehavioral: Combined balance and brisk walking training;Behavioral: Flexibility and strengthening exerciseThe Hong Kong Polytechnic UniversityNULLRecruiting30 Years80 YearsAll70N/AHong Kong
42NCT04322461
(ClinicalTrials.gov)
March 15, 202124/3/2020Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders PopulationEffect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKAParkinson Disease;Alzheimer DiseaseDietary Supplement: Betaquik MCT supplementUniversité de SherbrookeNestléNot yet recruiting60 YearsN/AAll20N/ANULL
43JPRN-jRCTs041190126
22/02/202110/03/2020Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body diseaseStudy 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 MasahisaJapan Agency for Medical Research and DevelopmentNot Recruiting>= 50age old< 80age oldBoth30Phase 2Japan
44NCT04643327
(ClinicalTrials.gov)
February 9, 202118/11/2020Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's DiseaseDouble-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept StudyParkinson Disease;Mild Cognitive Impairment;Memory ImpairmentDrug: Levetiracetam;Drug: PlaceboThe University of QueenslandQueensland University of Technology;Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's HospitalRecruitingN/AN/AAll28Phase 2Australia
45NCT04590612
(ClinicalTrials.gov)
January 202117/9/2020Improving Quality of Life in Early Parkinson's DiseaseThe Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease PatientsParkinson Disease;DepressionDrug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: CitalopramWestern University, CanadaNULLNot yet recruiting50 Years80 YearsAll30N/ANULL
46JPRN-jRCTs031200172
23/12/202026/10/2020Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipationMulticenter, 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 TakuMochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd.Not Recruiting>= 20age oldNot applicableBoth100N/AJapan
47NCT04634331
(ClinicalTrials.gov)
December 10, 20209/11/2020Dual-task Augmented Reality Treatment for Parkinson's DiseaseDual-task Augmented Reality Treatment for Parkinson's Disease (DART)Parkinson DiseaseBehavioral: Augmented Reality Multi-Modal Training;Behavioral: Traditional Multi-Modal TrainingThe Cleveland ClinicMichael J. Fox Foundation for Parkinson's ResearchActive, not recruiting18 YearsN/AAll50Phase 2United States
48NCT04506073
(ClinicalTrials.gov)
November 9, 202016/7/2020Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPDAllogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled TrialParkinson's DiseaseDrug: MSC+placebo;Drug: MSC;Drug: PlaceboThe University of Texas Health Science Center, HoustonMichael J. Fox Foundation for Parkinson's ResearchActive, not recruiting50 Years79 YearsAll45Phase 2United States
49NCT04620382
(ClinicalTrials.gov)
November 9, 202027/10/2020Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsEffect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsNeurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson DiseaseDrug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compressionVanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)Recruiting40 Years80 YearsAll31Early Phase 1United States
50NCT04387773
(ClinicalTrials.gov)
November 5, 202011/5/2020Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's DiseaseEffect of GOCOVRI on Quantity and Quality of Gait in Parkinson's DiseaseParkinson DiseaseDrug: GOCOVRIOregon Health and Science UniversityAdamas Pharmaceuticals, Inc.Recruiting50 Years80 YearsAll12Phase 4United States
51NCT04277247
(ClinicalTrials.gov)
November 2, 202010/2/2020Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's DiseaseBotulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control StudyDystonia Disorder;Parkinson DiseaseDrug: Botulinum toxin type A;Drug: PlaceboUniversity of CalgaryAllerganRecruiting30 Years100 YearsAll40Phase 2/Phase 3Canada
52NCT04386317
(ClinicalTrials.gov)
November 1, 202024/4/2020Terazosin Effect on Cardiac Changes in Early Parkinson's DiseaseThe Effect of a1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's DiseaseREM Sleep Behavior Disorder;Pre-motor Parkinson's Disease;Symptomatic Parkinson DiseaseDrug: TerazosinCedars-Sinai Medical CenterNULLRecruiting25 Years85 YearsAll15Phase 2United States
53NCT03947216
(ClinicalTrials.gov)
October 23, 20207/5/2019Randomized 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 DiseaseParkinson DiseaseDrug: 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 monitoringUniversity Hospital, Strasbourg, FranceNS-PARK;EUCLID Clinical Trial Platform;F-CRINRecruiting35 Years75 YearsAll130Phase 2France
54NCT04591535
(ClinicalTrials.gov)
September 28, 202011/9/2020PK Study of WD-1603 in Healthy SubjectsAn 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 ConditionsParkinson DiseaseDrug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
55NCT04553978
(ClinicalTrials.gov)
September 18, 202013/9/2020A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting ConditionsAn 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 ConditionsParkinson DiseaseDrug: WD-1603Hong Kong WD Pharmaceutical Co., LimitedNULLNot yet recruiting18 Years45 YearsAll8Phase 1NULL
56NCT04476017
(ClinicalTrials.gov)
September 11, 202015/7/2020A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive ImpairmentParkinson Disease;Cognitive DysfunctionDrug: SAGE-718Sage TherapeuticsNULLActive, not recruiting50 Years75 YearsAll18Phase 2United States
57NCT04524351
(ClinicalTrials.gov)
August 14, 202011/8/2020Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD)Alzheimer Disease;Parkinson DiseaseDrug: PosiphenAnnovis Bio Inc.ParexelActive, not recruiting45 YearsN/AAll75Phase 1/Phase 2United States
58NCT04513340
(ClinicalTrials.gov)
August 13, 202012/8/2020WD-1603 PK Study Under Fasting and Fed Conditions in Healthy SubjectsAN 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 CONDITIONSParkinson DiseaseDrug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
59NCT04449484
(ClinicalTrials.gov)
August 4, 202023/4/2019Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: MEDI1341;Other: PlaceboAstraZenecaNULLActive, not recruiting40 Years85 YearsAll25Phase 1United States
60NCT04483479
(ClinicalTrials.gov)
July 30, 202020/7/2020Orally 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 PeriodParkinson Disease;ConstipationDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLRecruiting30 Years90 YearsAll50Phase 2United States
61JPRN-UMIN000040889
2020/06/2424/06/2020Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's diseaseComparison 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 diseaseLevodopa-carbidopa continuous infusion gel (LCIG) therapyFujita Health University School of MedicineDepartment of GastroenterologyNULLRecruiting20years-oldNot applicableMale and Female200Phase 4Japan
62NCT04414813
(ClinicalTrials.gov)
June 202021/5/2019Stereotactic Transplantation of hAESCs for Parkinson's DiseaseClinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)Parkinson's DiseaseBiological: Human Amniotic Epithelial Stem CellsShanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaNot yet recruiting30 Years70 YearsAll3Early Phase 1NULL
63NCT03568968
(ClinicalTrials.gov)
May 15, 202014/6/2018A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's DiseaseA Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK StudyParkinson DiseaseDietary Supplement: Nicotinamide Riboside;Drug: PlaceboHaukeland University HospitalNULLRecruiting18 YearsN/AAll400N/ANorway
64NCT04459052
(ClinicalTrials.gov)
April 30, 202026/6/2020FDOPA PET and Nutritional Support in Parkinson's DiseasePhase II: Physiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: N acetyl cysteine;Drug: [F-18] Fluorodopa Positron Emission TomographyThomas Jefferson UniversityNULLActive, not recruiting30 YearsN/AAll50Phase 2United States
65NCT03959540
(ClinicalTrials.gov)
April 28, 202023/4/2019Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseA Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Levodopa (L-DOPA) + Standard careBial - Portela C S.A.NULLCompleted75 YearsN/AAll39United Kingdom
66EUCTR2018-002233-37-PL
(EUCTR)
23/04/202024/01/2020Evaluate 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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
67NCT02967250
(ClinicalTrials.gov)
April 1, 202013/9/2016Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA TreatmentParkinson DiseaseDrug: ursodeoxycholic acidUniversity of MinnesotaNULLNot yet recruiting18 YearsN/AAll20Phase 1United States
68NCT04269642
(ClinicalTrials.gov)
March 19, 202013/1/2020SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's DiseasePhase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's DiseaseEarly Parkinson's DiseaseDrug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mgPeptron, Inc.NULLActive, not recruiting40 Years75 YearsAll99Phase 2Korea, Republic of
69EUCTR2018-003941-41-AT
(EUCTR)
05/03/202019/06/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
258Phase 3United 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
70NCT04260581
(ClinicalTrials.gov)
March 1, 20205/2/2020Is Long-term Use of Amantadine Effective in PD?Is Long-term Use of Amantadine Effective in Parkinson Disease?Parkinson DiseaseDrug: Determination of drug effects through amantadine cessationSeoul National University HospitalNULLNot yet recruiting40 YearsN/AAll32N/AKorea, Republic of
71EUCTR2018-004156-37-ES
(EUCTR)
11/02/202006/11/2019A 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.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
72NCT04292223
(ClinicalTrials.gov)
February 10, 202028/2/2020Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisA 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: PimavanserinACADIA Pharmaceuticals Inc.NULLActive, not recruiting40 YearsN/AAll53Phase 4United States
73NCT04251585
(ClinicalTrials.gov)
February 4, 202028/1/2020Intranasal Insulin in Parkinson's DiseaseSingle Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's DiseaseParkinson DiseaseDrug: Regular Novolin R;Drug: PlaceboHealthPartners InstituteNULLRecruiting41 Years89 YearsAll30Phase 2United States
74EUCTR2018-003941-41-PT
(EUCTR)
03/02/202021/08/2019This 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
75NCT04428983
(ClinicalTrials.gov)
February 3, 202020/11/2019The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseThe Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseParkinson DiseaseDietary Supplement: Hericium erinaceus myceliumNational Cheng-Kung University HospitalNULLRecruiting50 Years79 YearsAll80N/ATaiwan
76EUCTR2018-003289-15-DE
(EUCTR)
28/01/202008/02/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany
77EUCTR2019-001657-42-SK
(EUCTR)
14/01/202001/10/2019A 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.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Hungary;Estonia;Slovakia;Poland;Germany
78EUCTR2018-003289-15-PT
(EUCTR)
13/01/202021/08/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;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
79NCT04152655
(ClinicalTrials.gov)
January 1, 20207/10/2019A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson DiseaseA Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)REM Sleep Behavior Disorder;Parkinson DiseaseDrug: Idebenone;Drug: Placebo oral tabletSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityPeking 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 UniversityRecruiting18 YearsN/AAll180Phase 2/Phase 3China
80NCT04687878
(ClinicalTrials.gov)
January 1, 202028/12/2020The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease PatientsEvaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical TrialParkinson DiseaseDrug: Insulin;Drug: Normal salinedr.dargahiNULLRecruiting17 YearsN/AAll40Phase 2Iran, Islamic Republic of
81EUCTR2018-004156-37-HU
(EUCTR)
19/12/201918/10/2019A 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.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
82NCT04097080
(ClinicalTrials.gov)
December 15, 201918/9/2019Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseComparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseParkinson DiseaseDrug: NBTX-001;Drug: Standard of CareNobilis Therapeutics Inc.NULLRecruiting18 YearsN/AAll60Phase 1Russian Federation
83NCT04191577
(ClinicalTrials.gov)
December 2, 201930/10/2019Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsA Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: CVN424 Low Dose;Drug: CVN424 High Dose;Drug: PlaceboCerevance Beta, Inc.NULLActive, not recruiting30 Years80 YearsAll135Phase 2United States
84NCT04768023
(ClinicalTrials.gov)
November 18, 201914/2/202112 Weeks Vitamin D Supplementation and Physical Activity in PD Patients With DBSInfluence 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 StimulationVitamin D Deficiency;Parkinson DiseaseDrug: Juvit D3;Behavioral: steps per day;Drug: PlaceboMedical University of GdanskNULLEnrolling by invitation40 Years90 YearsAll72N/APoland
85NCT03924414
(ClinicalTrials.gov)
November 15, 20192/4/2019Trial of Parkinson's And Zoledronic AcidTOPAZ: 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 DiseaseParkinson Disease;Osteoporosis;Parkinsonism;Parkinson's Disease and Parkinsonism;Atypical Parkinsonism;Progressive Supranuclear Palsy;Multiple System Atrophy;Vascular Parkinsonism;Dementia With Lewy BodiesDrug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: PlaceboCalifornia Pacific Medical Center Research InstituteNational Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's FoundationRecruiting60 YearsN/AAll3500Phase 4United States
86NCT04148391
(ClinicalTrials.gov)
November 14, 201930/10/2019NYX-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 DementiaMild Cognitive Impairment;Mild Dementia;Parkinson Disease;Lewy Body DiseaseDrug: Placebo Oral Capsule;Drug: NYX-458AptinyxCogState Ltd.;Worldwide Clinical TrialsRecruiting50 Years80 YearsAll100Phase 2United States
87NCT04175132
(ClinicalTrials.gov)
November 12, 201912/11/2019Binding 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 DiseaseHealthy;Parkinson DiseaseDrug: foligluraxH. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1Sweden
88NCT03652870
(ClinicalTrials.gov)
November 1, 20198/8/2018Antidepressants Trial in Parkinson's DiseaseA Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's DiseaseDepression;Parkinson DiseaseDrug: Nortriptyline;Drug: Escitalopram;Drug: PlaceboUniversity College, LondonLondon North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS LothianNot yet recruiting18 Years85 YearsAll408Phase 3NULL
89EUCTR2018-002942-35-GB
(EUCTR)
31/10/201905/09/2019A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s diseaseA 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 UnitNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408Phase 3United Kingdom
90EUCTR2018-003337-15-ES
(EUCTR)
17/10/201930/04/2019A 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) LimitedNULLAuthorised-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): noUnited States;Hungary;Czech Republic;Slovakia;Poland;Spain;India
91EUCTR2018-003941-41-BG
(EUCTR)
10/10/201926/06/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
258Phase 3United 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
92NCT04575259
(ClinicalTrials.gov)
October 10, 201929/9/2020OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Parkinson Disease DementiaDrug: ANAVEX2-73Anavex Life Sciences Corp.Anavex Australia Pty Ltd.;Anavex Germany GmbHActive, not recruiting50 Years85 YearsAll132Phase 2Australia;Spain
93EUCTR2018-003289-15-BG
(EUCTR)
10/10/201924/07/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United 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
94EUCTR2018-003941-41-IT
(EUCTR)
17/09/201918/01/2021This 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
95NCT04064983
(ClinicalTrials.gov)
September 14, 201919/8/2019Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's DiseaseIndividual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Parkinson's DiseaseParkinson DiseaseBiological: HB-adMSCsHope BiosciencesNULLNo longer available18 YearsN/AAllUnited States
96EUCTR2018-003028-35-GB
(EUCTR)
04/09/201915/11/2019A 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 UnitNULLAuthorised-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): noUnited Kingdom
97NCT04054960
(ClinicalTrials.gov)
September 20199/8/2019A Trial of tPCS on Parkinson's Disease OFF StateA Trial of tPCS on Parkinson's Disease OFF StateParkinson DiseaseDevice: Active tPCS;Device: Sham tPCS;Drug: Levodopa tabletWestern University, CanadaNULLNot yet recruiting40 Years80 YearsAll15N/ACanada
98EUCTR2018-003941-41-PL
(EUCTR)
23/08/201903/06/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
258Phase 3Portugal;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
99EUCTR2018-002234-21-ES
(EUCTR)
21/08/201911/06/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN 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, LLCNULLAuthorised-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): noUnited States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
100NCT04062526
(ClinicalTrials.gov)
August 14, 201914/8/2019Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CTEvaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)Parkinson Disease;Healthy VolunteerDrug: [18F]NOSUniversity of PennsylvaniaNULLRecruiting18 Years75 YearsAll30Early Phase 1United States
101EUCTR2018-003941-41-ES
(EUCTR)
13/08/201911/06/2019This 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
102NCT04043338
(ClinicalTrials.gov)
August 11, 201924/7/2019Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult SubjectsParkinson's DiseaseDrug: XC130-A10H;Drug: PlaceboXoc PharmaceuticalsCelerionActive, not recruiting18 Years75 YearsAll56Phase 1United States
103EUCTR2018-003941-41-GB
(EUCTR)
09/08/201916/05/2019This 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3New Zealand;Germany;Bulgaria;Denmark;Australia;Peru;Poland;Argentina;Canada;Mexico;Hungary;France;United Kingdom;Italy;Israel;Chile;Russian Federation;Austria;Ukraine;Spain;Estonia;Portugal;United States
104JPRN-UMIN000037421
2019/08/0101/08/2019A study on improvement of cognitive function by istradefylline for parkinson diseaseAn 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 diseasePrescription 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 HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
105JPRN-UMIN000037422
2019/08/0101/08/2019An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson diseaseAn 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 diseasePrescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months.Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
106EUCTR2018-003941-41-HU
(EUCTR)
30/07/201901/08/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
107EUCTR2018-003289-15-PL
(EUCTR)
19/07/201907/05/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United 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
108NCT03575195
(ClinicalTrials.gov)
July 15, 201921/6/2018Microbiota Intervention to Change the Response of Parkinson's DiseaseMicrobiota Intervention to Change the Response of Parkinson's DiseaseParkinson DiseaseDrug: Rifaximin;Other: PlaceboUniversity of California, San FranciscoNova Southeastern University;Gateway Institute for Brain ResearchRecruiting30 YearsN/AAll86Phase 1/Phase 2United States
109EUCTR2018-002144-85-ES
(EUCTR)
11/07/201912/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 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 DeutschlandNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan
110EUCTR2018-002144-85-DK
(EUCTR)
08/07/201914/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 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 DeutschlandNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan
111EUCTR2018-003941-41-EE
(EUCTR)
04/07/201929/05/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
258Phase 3Portugal;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
112EUCTR2018-003289-15-DK
(EUCTR)
02/07/201914/03/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United 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
113NCT03977441
(ClinicalTrials.gov)
July 201912/5/2019the Efficacy and Safety of Agomelatine in the Patients With Parkinson's DiseaseA 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 DiseaseParkinson Disease;Depression;Sleep Disorders;Circadian Rhythm DisordersDrug: Agomelatine or PIaceboSecond Affiliated Hospital of Soochow UniversityNULLNot yet recruiting30 Years75 YearsAll240Phase 4NULL
114EUCTR2018-003289-15-ES
(EUCTR)
26/06/201927/06/2019This 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 LimitedNULLAuthorised-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): noUnited States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany
115EUCTR2018-003337-15-HU
(EUCTR)
18/06/201912/04/2019A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease Early Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-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): noUnited States;Hungary;Slovakia;Poland;Spain;India
116NCT03938922
(ClinicalTrials.gov)
June 13, 201918/4/2019A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease DementiaA Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.Parkinson Disease;DementiaDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLActive, not recruiting30 Years90 YearsAll40Phase 1United States
117NCT03939559
(ClinicalTrials.gov)
June 10, 20193/5/2019The Efficiency of Home Based Dual Task Training in Parkinson DiseaseThe Efficiency of Home Based Dual Task Training in Parkinson DiseaseParkinson DiseaseProcedure: Static, dynamic and functional balance exercises;Procedure: Static, dynamic and functional balance exercises with dual taskIstanbul University-CerrahpasaNULLNot yet recruiting30 Years80 YearsAll60N/ANULL
118JPRN-UMIN000036952
2019/06/0404/06/2019A 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 PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
119EUCTR2018-003289-15-HU
(EUCTR)
04/06/201905/04/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Denmark;Bulgaria;Germany
120ChiCTR1900022534
2019-06-012019-04-15Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trialEfficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial non-motor symptoms of Parkinson’s diseaseentacapone 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 HainanNULLPending4075Bothentacapone group:194;pramipexole group:194;N/AChina
121JPRN-UMIN000036908
2019/05/3131/05/2019A dementia study by 11C-PiB, 18F-FDG PETA 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 PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
122JPRN-jRCTs031180248
29/05/201912/03/2019N/AIntervention study for the effect of Istradefylline on adjustment of Levodopa in Parkinson's Disease - Istra adjust PD Parkinson's diseaseArm 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 TakuKyowa Kirin Co., LtdNot Recruiting>= 30age old<= 84age oldBoth111N/AJapan
123NCT03671785
(ClinicalTrials.gov)
May 15, 201912/9/2018Study of the Fecal Microbiome in Patients With Parkinson's DiseaseA 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 DiseaseParkinson DiseaseDrug: PRIM-DJ2727;Drug: Placebo oral capsuleThe University of Texas Health Science Center, HoustonKelsey Research FoundationActive, not recruiting55 Years75 YearsAll12Phase 1United States
124EUCTR2018-003289-15-AT
(EUCTR)
15/05/201922/03/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3United 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
125NCT03693872
(ClinicalTrials.gov)
May 15, 20191/10/2018Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsEvaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsParkinson DiseaseDrug: Apomorphine;Drug: Dopaminergic Agonist + ApomorphineRennes University HospitalNULLRecruiting18 YearsN/AAll42N/AFrance
126NCT03781167
(ClinicalTrials.gov)
April 29, 201918/12/2018A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD)A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLActive, not recruiting30 YearsN/AAll244Phase 3United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France
127EUCTR2018-002233-37-DE
(EUCTR)
17/04/201908/01/2019Evaluate 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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
128NCT04420910
(ClinicalTrials.gov)
April 15, 20194/6/2020Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseInvestigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseParkinson Disease;Balance;Muscle Strength;Mobility;Non-motor SymptomsOther: Non-Motor Symptoms;Other: Balance;Other: Lower Limb Strength;Other: Functional mobilityAnkara Yildirim Beyazit UniversityNULLCompleted50 Years65 YearsAll44Turkey
129JPRN-jRCTs051180214
12/04/201927/03/2019The usefulness of flutemetamol for diagnostic imaging of neurogenerative diseaseThe 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 YoshiakiNULLRecruiting>= 20age oldNot applicableBoth100N/AJapan
130EUCTR2018-003289-15-EE
(EUCTR)
11/04/201930/01/2019This 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
131EUCTR2017-002426-20-FR
(EUCTR)
05/04/201926/11/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA 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 SpANULLNot RecruitingFemale: yes
Male: yes
177Phase 4France;Spain;Austria
132EUCTR2016-000657-12-GR
(EUCTR)
04/04/201911/01/2019A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
290Phase 2Taiwan;United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
133EUCTR2018-002233-37-CZ
(EUCTR)
18/03/201911/12/2018Evaluate 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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy
134NCT03816020
(ClinicalTrials.gov)
March 9, 20197/12/2018NAD-supplementation in Drug naïve Parkinson's DiseaseNAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesDietary Supplement: Nicotinamide Riboside;Other: PlaceboHaukeland University HospitalNULLCompleted18 YearsN/AAll30N/ANorway
135EUCTR2017-005170-19-FI
(EUCTR)
06/03/201907/12/2018A 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 StudyA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
136NCT03820037
(ClinicalTrials.gov)
March 201925/1/2019Relative Bioavailability and Bioequivalence of OpicaponeA 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 SubjectsParkinson DiseaseDrug: Ongentys;Drug: BIA 9-1067 (test)Bial - Portela C S.A.NULLNot yet recruiting18 Years55 YearsAll45Phase 1United Kingdom
137NCT03829657
(ClinicalTrials.gov)
February 22, 201910/1/2019Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic FailureA Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic FailureSymptomatic Neurogenic Orthostatic Hypotension;MSA;Parkinson's Disease (PD);Pure Autonomic Failure (PAF)Drug: ampreloxetine;Drug: PlaceboTheravance BiopharmaNULLActive, not recruiting30 YearsN/AAll203Phase 3United States;Argentina;Australia;Austria;Bulgaria;Canada;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;New Zealand;Poland;Portugal;Russian Federation;Spain;Ukraine;United Kingdom
138NCT03815071
(ClinicalTrials.gov)
February 1, 201921/1/2019A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem CellsClinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's DiseaseParkinson DiseaseDrug: Ips-nsc cellsAllife 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 HospitalNot yet recruiting18 Years60 YearsAll10Early Phase 1NULL
139EUCTR2017-003458-18-SE
(EUCTR)
23/01/201910/12/2018A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA 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)NULLNot 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): noSweden
140EUCTR2017-002426-20-AT
(EUCTR)
22/01/201903/12/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA 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 SpANULLNot RecruitingFemale: yes
Male: yes
105Phase 4Spain;Austria
141EUCTR2018-002877-23-AT
(EUCTR)
21/01/201907/12/2018Oxytocin 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 InnsbruckNULLNot RecruitingFemale: no
Male: yes
76Phase 2Austria
142NCT03826134
(ClinicalTrials.gov)
January 17, 201930/1/2019A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy SubjectsInterventional, 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 SubjectsParkinson DiseaseDrug: [11C]PXT012253H. Lundbeck A/SNULLCompleted20 Years50 YearsAll7Early Phase 1Sweden
143JPRN-UMIN000035602
2019/01/1121/01/2019Hydrogen gas inhalation randomized double blinded trial for Parkinson's diseaseHydrogen gas inhalation randomized double blinded trial for Parkinson's disease - Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease Parkinson's diseasehydrogen 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 HospitalNULLComplete: follow-up complete40years-old80years-oldMale and Female20Not selectedJapan
144NCT03659682
(ClinicalTrials.gov)
January 2, 20193/9/2018GLP1R in Parkinson's DiseaseEffect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's DiseaseParkinson DiseaseDrug: SemaglutideOslo University HospitalNULLNot yet recruiting40 Years75 YearsAll120Phase 2NULL
145NCT03727295
(ClinicalTrials.gov)
January 1, 201930/10/2018Idebenone Treatment of Early Parkinson's DiseasesymptomsA Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor SymptomsOxidative Stress is an Important Cause of Parkinson's DiseaseDrug: Idebenone/placeboSecond Affiliated Hospital of Soochow UniversityQilu Pharmaceutical Co., Ltd.Not yet recruiting30 Years80 YearsAll180Phase 4NULL
146NCT03942172
(ClinicalTrials.gov)
November 27, 20186/5/2019Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesTreatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesParkinson DiseaseDevice: SpotOn balance glassesSpotOn Therapeutics Ltd.NULLSuspended30 YearsN/AAll50N/AIsrael
147NCT03822364
(ClinicalTrials.gov)
November 26, 201818/12/2018Staccato Apomorphine Single and Multi Dose PKA 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 DiseaseParkinson DiseaseDrug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5Alexza Pharmaceuticals, Inc.NULLCompleted18 Years60 YearsAll56Phase 1Netherlands
148NCT03823638
(ClinicalTrials.gov)
November 20, 201820/11/2018Safety, Tolerability and Effects of Mannitol in Parkinson's DiseaseA 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 DiseaseParkinson DiseaseDietary Supplement: Oral D-Mannitol of PlaceboHadassah Medical OrganizationNULLRecruiting40 Years75 YearsAll60Phase 2Israel
149NCT03713957
(ClinicalTrials.gov)
November 12, 201818/10/2018A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentParkinson DiseaseDrug: GRF6021;Other: PlaceboAlkahest, Inc.Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years85 YearsAll79Phase 2United States;Australia;France
150NCT03733561
(ClinicalTrials.gov)
November 9, 20186/11/2018A Study to Assess Pharmacokinetic Profiles of LY03003 and NeuproA 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 VolunteersParkinson DiseaseDrug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal PatchLuye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll40Phase 1United States
151EUCTR2018-001887-46-GB
(EUCTR)
08/11/201819/06/2019Trial 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 TrustNULLAuthorised-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): noUnited Kingdom
152NCT03667404
(ClinicalTrials.gov)
November 6, 201810/9/2018Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability StudyGut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability StudyParkinson Disease;Intestinal Bacteria Flora Disturbance;Dietary ModificationDietary Supplement: Resistant maltodextrin;Dietary Supplement: maltodextrinNorthwestern UniversityUniversity of Illinois at ChicagoRecruiting60 YearsN/AAll30Phase 2United States
153NCT03670953
(ClinicalTrials.gov)
November 6, 201812/9/2018A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor FluctuationsA Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor FluctuationsParkinson's Disease (Disorder)Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placeboImpax Laboratories, LLCNULLCompleted40 YearsN/AAll631Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
154NCT04629404
(ClinicalTrials.gov)
November 5, 20185/11/2020A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD PatientsA 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 DiseaseParkinson DiseaseDrug: LY03003;Drug: PlaceboLuye Pharma Group Ltd.NULLCompleted30 YearsN/AAll32Phase 1China
155NCT03727139
(ClinicalTrials.gov)
November 1, 201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term SafetyParkinson's DiseaseDrug: RasagilineTakedaNULLCompletedN/AN/AAll1021Japan
156NCT03069911
(ClinicalTrials.gov)
November 1, 201828/2/2017Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseRandomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseParkinson Disease;DepressionBiological: OnabotulinumtoxinA;Biological: ControlJohns Hopkins UniversityNULLTerminated18 Years95 YearsAll3Phase 1United States
157EUCTR2016-002033-30-NL
(EUCTR)
31/10/201815/11/2017A 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 fluctuationsA 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.NULLAuthorised-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): noSerbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
158EUCTR2017-003415-19-ES
(EUCTR)
31/10/201820/08/2018A 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Spain;Germany
159NCT03720418
(ClinicalTrials.gov)
October 17, 201816/10/2018Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's DiseaseA Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)Parkinson DiseaseDrug: OXB-102;Other: Imitation Surgical Procedure (ISP)Sio Gene TherapiesNULLActive, not recruiting30 Years70 YearsAll30Phase 1/Phase 2France;United Kingdom
160EUCTR2018-000346-19-FI
(EUCTR)
03/10/201809/07/2018An 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 PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
161EUCTR2016-004610-95-DE
(EUCTR)
01/10/201827/02/2018Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
357Phase 2France;United States;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
162NCT03229174
(ClinicalTrials.gov)
August 23, 201821/4/2017Brain Perfusion & Oxygenation in Parkinson's Disease With NOHEvaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus PlaceboParkinson Disease;Neurogenic Orthostatic HypotensionDrug: Droxidopa;Drug: PlaceboWilliam Ondo, MDLundbeck LLCRecruiting18 Years85 YearsAll28Phase 4United States
163NCT03567447
(ClinicalTrials.gov)
August 17, 201821/5/2018Effect 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 PatientDrug: Droxidopa;Other: PlaceboSt. Joseph's Hospital and Medical Center, PhoenixH. Lundbeck A/S;Arizona State UniversityRecruiting30 Years83 YearsAll10Phase 2United States
164NCT03675282
(ClinicalTrials.gov)
August 14, 20185/9/2018Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and ControlsQuantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and ControlsParkinson Disease;REM Sleep Behavior Disorder;HealthyDrug: (11C)PE2I;Drug: IoflupaneWeill Medical College of Cornell UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting20 Years100 YearsAll82Phase 1/Phase 2United States
165EUCTR2016-004610-95-FR
(EUCTR)
08/08/201801/03/2018Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
311Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden
166NCT03773796
(ClinicalTrials.gov)
August 6, 201819/7/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and EfficacyParkinson DiseaseDrug: Nabilone 0.25 mgMedical University InnsbruckNULLRecruiting30 Years100 YearsAll48Phase 3Austria
167JPRN-UMIN000033285
2018/08/0105/07/2018The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trialThe 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 diseaseOral 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 HospitalDepartment of Neurology, Nishi-Niigata Chuo HospitalPending50years-oldNot applicableMale and Female100Not selectedJapan
168EUCTR2017-005170-19-SE
(EUCTR)
30/07/201810/04/2018A 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 StudyA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Sweden;Finland
169JPRN-UMIN000033409
2018/07/3017/07/2018Prevention 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 diseasePretreatment 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 UniversityNULLComplete: follow-up complete20years-old85years-oldMale and Female20Phase 1Japan
170NCT03611569
(ClinicalTrials.gov)
July 25, 201826/7/2018Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseInterventional, 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 DiseaseHealthy;Parkinson DiseaseDrug: Lu AF82422;Drug: PlaceboH. Lundbeck A/SNULLCompleted18 Years80 YearsAll74Phase 1United States
171EUCTR2018-001209-95-IT
(EUCTR)
05/07/201803/08/2021An 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 diseaseAn 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 LTDNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Spain;Italy
172NCT03521635
(ClinicalTrials.gov)
July 3, 201811/4/2018The 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-DopaA 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 DiseaseDrug: Pramipexole SR;Drug: Pramipexole IRBoehringer IngelheimNULLCompleted30 YearsN/AAll98Phase 4China
173JPRN-UMIN000033454
2018/07/0120/07/2018A 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 Diseaserobot 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 MedicineNULLRecruiting40years-old80years-oldMale and Female50Not selectedJapan
174NCT03562494
(ClinicalTrials.gov)
June 28, 201816/5/2018VY-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 FluctuationsParkinson's DiseaseBiological: VY-AADC02;Other: Sham (Placebo) SurgeryNeurocrine BiosciencesVoyager TherapeuticsActive, not recruiting40 Years75 YearsAll85Phase 2United States
175NCT03439943
(ClinicalTrials.gov)
June 13, 201813/2/2018Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's DiseaseMulticenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: Lixisenatide;Drug: placeboUniversity Hospital, ToulouseCure Parkinson;Réseau NS-Park;EUCLID;SanofiActive, not recruiting40 Years75 YearsAll156Phase 2France
176NCT03456687
(ClinicalTrials.gov)
June 5, 20181/3/2018Effects of Exenatide on Motor Function and the BrainEffects of Exenatide on Motor Function and the BrainParkinson's DiseaseDrug: ExenatideUniversity of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting40 Years77 YearsAll5Phase 1United States
177EUCTR2018-000346-19-SE
(EUCTR)
04/06/201809/04/2018An 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 PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
178NCT03684122
(ClinicalTrials.gov)
June 1, 201823/9/2018Use 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 DiseaseBiological: Injection of Umbilical cord derived MSCsUniversity of JordanNULLActive, not recruiting20 Years75 YearsAll10Phase 1/Phase 2Jordan
179EUCTR2017-002780-17-ES
(EUCTR)
21/05/201812/02/2018Study 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;United States;Spain;Austria;Netherlands;Italy
180EUCTR2016-004610-95-ES
(EUCTR)
18/05/201807/03/2018Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
311Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy;Sweden
181EUCTR2017-004475-31-CZ
(EUCTR)
09/05/201809/05/2018Safety 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.NULLNot 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): noFrance;United States;Hungary;Czech Republic;Germany
182EUCTR2017-002780-17-FR
(EUCTR)
26/04/201827/02/2018-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.NULLNot 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): noUnited States;France;Spain;Austria;Netherlands;Italy
183EUCTR2017-004475-31-HU
(EUCTR)
17/04/201809/02/2018Safety 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Czech Republic;Hungary;Germany
184EUCTR2017-004253-16-AT
(EUCTR)
13/04/201827/02/2018Investigation 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 NeurologieNULLNot 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): noAustria
185EUCTR2017-002780-17-IT
(EUCTR)
10/04/201804/11/2020study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusionA 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
186EUCTR2016-003456-70-DE
(EUCTR)
04/04/201803/04/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn 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.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
187EUCTR2016-000657-12-AT
(EUCTR)
03/04/201817/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
188ChiCTR1800015331
2018-04-012018-03-23Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's DiseaseDopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease Parkinson's diseasede 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 SciencesNULLRecruiting5080Bothde novo PD patients:50;de novo PD patients:50;de novo PD patients:50;China
189EUCTR2017-004297-34-GB
(EUCTR)
31/03/201822/06/2018Use 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 UniversityNULLNot RecruitingFemale: yes
Male: yes
28Phase 2United Kingdom
190EUCTR2018-000405-23-FI
(EUCTR)
27/03/201821/02/2018Postitron emission tomography imaging of neuroinflammation in Parkinson´s diseaseIn 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 CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
14Phase 2Finland
191EUCTR2016-004610-95-AT
(EUCTR)
23/03/201804/01/2018Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
192NCT03301272
(ClinicalTrials.gov)
March 22, 201813/9/2017Effectiveness of Botox on Reducing Rest Tremor in Parkinson's DiseaseEffectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot StudyParkinson DiseaseDrug: Onabotulinumtoxin A Injection;Other: PlaceboUniversity of North Carolina, Chapel HillNULLCompleted45 Years80 YearsAll16Phase 2United States
193NCT02940912
(ClinicalTrials.gov)
January 31, 201814/10/2016Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseDouble 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 DiseaseParkinson DiseaseDrug: Apomorphine;Drug: PlaceboClinique Beau SoleilNULLActive, not recruiting35 Years90 YearsAll45Phase 4France
194NCT03440112
(ClinicalTrials.gov)
January 29, 201826/1/2018Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil ArmModulation of GABA-A Receptors and Axial Motor Impairments in ParkinsonParkinson DiseaseDrug: 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, PhDNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting50 YearsN/AAll30Phase 1/Phase 2United States
195NCT03329508
(ClinicalTrials.gov)
January 29, 201830/10/2017A Phase 3 Study With P2B001 in Subjects With Early Parkinson'sA 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 DiseaseDrug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ERPharma Two B Ltd.NULLActive, not recruiting35 Years80 YearsAll525Phase 3United States;Canada;Germany;Spain
196JPRN-UMIN000030930
2018/01/2901/01/2019Study 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 diseaseAdministration of febuxostat 20 mg and inosine 500 mg twice a day for 58 daysStaGen Co. Ltd.NULLComplete: follow-up complete20years-old80years-oldMale and Female30Not selectedJapan
197EUCTR2016-001403-23-HU
(EUCTR)
23/01/201822/01/201812-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn 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. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
198ChiCTR1800014542
2018-01-222018-01-20Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's diseaseUp-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease Parkinson's DiseasePD group:propofol;NPD group:propofol;Xuanwu Hospital of CCMUNULLRecruiting1865BothPD group:40;NPD group:40;China
199NCT03531086
(ClinicalTrials.gov)
January 19, 20188/5/2018Idiopathic Parkinson's Progression and Dopamine Transporter SPECTExploring Dopamine Transporter Single-photon Emission Computer Tomography Quantification as a Measure of Disease Progression in Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Ioflupane I 123Julie GurwellNULLActive, not recruiting40 Years75 YearsAll12United States
200EUCTR2016-003456-70-AT
(EUCTR)
04/01/201816/11/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn 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.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
201EUCTR2017-003254-17-ES
(EUCTR)
21/12/201722/11/2017Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's diseaseA 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 PauNULLNot RecruitingFemale: yes
Male: yes
36Phase 4Spain
202EUCTR2017-003458-18-GB
(EUCTR)
19/12/201727/09/2017A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA 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)NULLNot 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): noUnited Kingdom;Sweden
203EUCTR2017-000877-35-IT
(EUCTR)
04/12/201710/11/2020A 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 BIONULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
204JPRN-UMIN000030084
2017/12/0101/12/2017Practical 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 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 UniversityNULLComplete: follow-up complete50years-oldNot applicableMale and Female12Phase 1,2Japan
205NCT03944785
(ClinicalTrials.gov)
November 30, 20171/5/2019Clinical 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)TabletsIdiopathic Parkinson DiseaseDrug: XADAGO (safinamide)Supernus Pharmaceuticals, Inc.NULLCompleted30 Years80 YearsAll164United States
206EUCTR2016-002033-30-GB
(EUCTR)
27/11/201705/09/2017A 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 fluctuationsA 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.NULLNot 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): noSerbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
207NCT03194217
(ClinicalTrials.gov)
November 10, 201719/6/2017BEN-2001 in Parkinson Disease Patients With Excessive Daytime SleepinessDose 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 DiseaseDrug: BEN-2001;Drug: PlaceboBenevolentAI BioNULLCompleted50 Years80 YearsAll244Phase 2United States
208NCT03305809
(ClinicalTrials.gov)
November 9, 20174/10/2017A 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 DementiaDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted40 Years85 YearsAll344Phase 2United States;Canada;Puerto Rico;China
209EUCTR2016-002033-30-HU
(EUCTR)
08/11/201719/09/2017A 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 fluctuationsA 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.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany
210NCT02611167
(ClinicalTrials.gov)
November 1, 201711/11/2015Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseasePilot Phase I Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseaseParkinson's DiseaseBiological: 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, HoustonNULLCompleted45 Years70 YearsAll20Phase 1United States
211NCT03232996
(ClinicalTrials.gov)
November 1, 201724/7/2017Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Parkinson Disease;ParkinsonOther: Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseUniversity of ManitobaNULLCompleted55 Years70 YearsAll30N/ACanada
212NCT03205956
(ClinicalTrials.gov)
October 19, 201729/6/2017Measuring Parkinson's Disease ProgressionDopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PDParkinson's DiseaseDrug: LevodopaKevin J. Black, MDThe Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years79 YearsAll31Phase 1United States
213EUCTR2017-000877-35-DE
(EUCTR)
19/10/201704/09/2017A 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 BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
214NCT03205488
(ClinicalTrials.gov)
October 16, 201728/6/2017Nilotinib in Parkinson's DiseaseA 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 DiseaseParkinson DiseaseDrug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: PlaceboNorthwestern UniversityUniversity of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years79 YearsAll76Phase 2United States
215EUCTR2017-001673-17-FI
(EUCTR)
03/10/201729/08/2017A 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 ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Finland;Sweden
216NCT03769896
(ClinicalTrials.gov)
October 3, 20176/12/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal StudyParkinson DiseaseDrug: Nabilone 0.25 mg;Drug: PlaceboMedical University InnsbruckNULLCompleted30 Years100 YearsAll48Phase 2Austria
217EUCTR2015-004175-73-FI
(EUCTR)
27/09/201707/07/2016A 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 PlcNULLNot RecruitingFemale: yes
Male: yes
17Phase 1;Phase 2Finland
218EUCTR2017-000128-81-DE
(EUCTR)
20/09/201706/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 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 YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
219EUCTR2017-000192-86-AT
(EUCTR)
15/09/201710/08/2017Investigation 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 NeurologieNULLNot 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): noAustria
220JPRN-jRCTs041180018
04/09/201720/12/2018Pupillary autonomic dysfunction and visual hallucination in Parkinson's diseaseAssociation 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 diseasesTwo 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 eyekatsuno MasahisaNULLComplete>= 40age oldNot applicableBoth40Phase 2Japan
221EUCTR2017-000128-81-ES
(EUCTR)
28/08/201712/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 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 YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
222EUCTR2017-000877-35-CZ
(EUCTR)
09/08/201705/06/2017A 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 BioNULLNot 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): noUnited States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
223EUCTR2017-000877-35-GB
(EUCTR)
08/08/201717/07/2017A 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 BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
224EUCTR2017-000877-35-ES
(EUCTR)
03/08/201709/06/2017A 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 BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy
225EUCTR2014-004865-26-GR
(EUCTR)
01/08/201725/04/201726-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
226EUCTR2017-000262-30-IT
(EUCTR)
10/07/201704/11/2020Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuationsEfficacy, 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Italy
227EUCTR2017-000135-14-ES
(EUCTR)
07/07/201709/06/2017A 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 LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;Italy;United Kingdom
228EUCTR2016-003961-25-DE
(EUCTR)
30/06/201701/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA 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 TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
229NCT04223245
(ClinicalTrials.gov)
June 29, 20172/12/2019A Home Program Using Multimodal Sensory Feedback for People With Parkinson DiseaseA Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.Parkinson DiseaseBehavioral: exercise+multi-modal sensory feedback (MMSF);Behavioral: Exercise onlyRegis UniversityNULLCompleted21 YearsN/AAll26N/AUnited States
230NCT03100149
(ClinicalTrials.gov)
June 27, 201729/3/2017A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's DiseaseA 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 ExtensionParkinson's DiseaseDrug: RO7046015;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedActive, not recruiting40 Years80 YearsAll316Phase 2United States;Austria;France;Germany;Spain
231NCT03195231
(ClinicalTrials.gov)
June 25, 201720/6/2017Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's DiseaseWuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.Antidepressive AgentsDrug: Wuling Powder;Drug: PlaceboBeijing HospitalTongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical UniversityNot yet recruiting40 YearsN/AAll120Phase 4NULL
232EUCTR2015-005814-31-ES
(EUCTR)
22/06/201721/04/2017-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.NULLNot RecruitingFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
233EUCTR2017-000135-14-GB
(EUCTR)
15/06/201717/03/2017A 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 LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
234NCT03083132
(ClinicalTrials.gov)
June 13, 20177/3/2017Modafinil 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 DiseaseParkinson DiseaseDrug: modafinil 50mg;Drug: Placebo oral capsuleUniversity of ArkansasNULLCompleted50 Years90 YearsAll23Early Phase 1United States
235EUCTR2016-003961-25-ES
(EUCTR)
08/06/201727/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA 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 TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
236EUCTR2017-000135-14-DE
(EUCTR)
06/06/201710/03/2017A 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 LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;Italy;United Kingdom
237EUCTR2016-003961-25-HU
(EUCTR)
31/05/201703/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA 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 TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
238EUCTR2017-000135-14-IT
(EUCTR)
30/05/201704/11/2020A 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 LevodopaStudio 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.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2France;Spain;Austria;Germany;United Kingdom;Italy
239EUCTR2017-000135-14-AT
(EUCTR)
26/05/201708/03/2017A 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 LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
240NCT03174938
(ClinicalTrials.gov)
May 15, 201728/5/2017The Swedish BioFINDER 2 StudyThe Swedish BioFINDER 2 StudyDementia;Alzheimer Disease;Parkinson Disease;Lewy Body Disease;Parkinson-Dementia Syndrome;Frontotemporal Degeneration;Semantic Dementia;Progressive Nonfluent Aphasia;Progressive Supranuclear Palsy;Corticobasal Degeneration;Multiple System Atrophy;Mild Cognitive ImpairmentDiagnostic Test: Flutemetamol F18 Injection;Diagnostic Test: [18F]-RO6958948;Diagnostic Test: Elecsys (Roche) Abeta42, Ttau and Ptau;Diagnostic Test: Lumipulse (Fujirebio) Abeta42, Ttau and PtauSkane University HospitalLund UniversityRecruiting20 Years100 YearsAll1505N/ASweden
241EUCTR2015-004507-23-FI
(EUCTR)
08/05/201730/03/2017Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
242NCT03115827
(ClinicalTrials.gov)
April 18, 20179/3/2017Norepinephrine-targeted Therapy for Action Control in Parkinson DiseaseNorepinephrine-targeted Therapy for Action Control in Parkinson DiseaseParkinson DiseaseDrug: Droxidopa;Drug: CarbidopaVanderbilt University Medical CenterH. Lundbeck A/S;American Academy of NeurologyCompleted18 YearsN/AAll15Phase 4United States
243EUCTR2016-004629-18-NL
(EUCTR)
13/04/201717/01/2017The influence of stress on Parkinson's tremorThe 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 NijmegenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noNetherlands
244JPRN-jRCTs051180185
07/04/201726/03/2019APISJ StudyIntervention 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 MakioKyowa Kirin Co., Ltd.Complete>= 30age oldNot applicableBoth30N/AJapan
245EUCTR2016-003961-25-GB
(EUCTR)
04/04/201716/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA 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 TherapiesNULLNot 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): noUnited States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
246NCT02953665
(ClinicalTrials.gov)
April 3, 201721/10/2016Safety and Efficacy of Liraglutide in Parkinson's DiseaseA Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's DiseaseParkinson DiseaseDrug: Liraglutide;Drug: PlaceboCedars-Sinai Medical CenterThe Cure Parkinson's Trust;Novo Nordisk A/SActive, not recruiting25 Years85 YearsAll63Phase 2United States
247JPRN-UMIN000026128
2017/04/0101/04/2017Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease Parkinson's diseaseadministe pilocarpine and dipivefrine
administe pilocarpine and dipivefrine
Nagoya UniversityNULLRecruiting40years-old90years-oldMale and Female60Not selectedJapan
248EUCTR2016-001403-23-GR
(EUCTR)
31/03/201714/10/201612-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. KGNULLNot 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): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
249EUCTR2016-001575-71-ES
(EUCTR)
16/03/201717/01/2017A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEA 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.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Israel;Germany
250JPRN-UMIN000026492
2017/03/1515/03/2017Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's DiseaseIntervention 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 diseaseIn 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 HospitalClinical Research Center, Wakayama Medical UniversityComplete: follow-up complete30years-oldNot applicableMale and Female30Not selectedJapan
251EUCTR2015-003513-24-SK
(EUCTR)
14/03/201704/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
252JPRN-jRCTs071180014
08/03/201729/01/2019ODYSSEI StudyIntervention 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 YoshioKyowa Kirin Co., Ltd.Not Recruiting>= 30age old< 80age oldBoth280N/AN A;Japan
253EUCTR2015-005814-31-CZ
(EUCTR)
03/03/201701/12/2016-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.NULLNot 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): noFrance;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
254EUCTR2015-004507-23-HU
(EUCTR)
24/02/201704/01/2017Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
255EUCTR2016-001403-23-FI
(EUCTR)
22/02/201731/08/201612-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. KGNULLNot 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): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
256EUCTR2016-000657-12-IT
(EUCTR)
16/02/201708/02/2017A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
276Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
257EUCTR2015-004344-19-DE
(EUCTR)
07/02/201727/09/2016An international trial of deferiprone in patients with Parkinson’s diseaseA 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
ApoPharmaNULLNot 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): noFrance;Canada;Germany;United Kingdom
258EUCTR2015-005814-31-DE
(EUCTR)
07/02/201724/05/2016-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.NULLAuthorised-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): noUnited States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
259JPRN-UMIN000025645
2017/02/0117/01/2018Cross sectional analysis of Intestinal flora of Parkinson's disease: Parkinson's diseaseLevodopa/carbidopa intestinal gelJuntendo University School of MedicineNULLPendingNot applicableNot applicableMale and Female20Not applicableJapan
260EUCTR2016-000657-12-DE
(EUCTR)
26/01/201717/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
261EUCTR2016-000657-12-PT
(EUCTR)
09/01/201725/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
290Phase 2Germany;Norway;Japan;Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Sweden
262NCT02954978
(ClinicalTrials.gov)
January 20171/11/2016Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's DiseaseA 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 DiseaseParkinson Disease;Parkinsons Disease With DementiaDrug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna]Georgetown UniversityNULLActive, not recruiting40 Years90 YearsAll75Phase 2United States
263NCT03034564
(ClinicalTrials.gov)
January 201725/1/2017A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseParkinson Disease;Fatigue;ParkinsonismDrug: Northera;Drug: Placebo Oral TabletThe Cooper Health SystemNULLTerminated18 YearsN/AAll1Phase 4United States
264EUCTR2016-001575-71-DE
(EUCTR)
23/12/201626/09/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEA 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.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Israel;Germany
265EUCTR2016-002033-30-BE
(EUCTR)
19/12/201621/11/2016A 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 fluctuationsA 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.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
266JPRN-UMIN000024859
2016/12/1416/11/2016The 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 diseaseSwitching from Dopamine agonist to Zonisamide.

Intervention period of 12 weeks.
Medical Corporation Abe Neurology ClinicNULLComplete: follow-up continuing30years-oldNot applicableMale and Female50Not applicableJapan
267ChiCTR2000037957
2016-12-012020-09-07Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's diseaseClinical 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 diseaseExperimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline;Shanghai Jing'an District Central HospitalNULLCompleted4575BothExperimental group:27;control group:9;China
268NCT02934919
(ClinicalTrials.gov)
December 201614/10/2016Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyEvaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyImpulse Control Disorders;Parkinson DiseaseDrug: NalmefeneUniversity Hospital, Clermont-FerrandNULLNot yet recruiting18 Years80 YearsBoth30Phase 2France
269NCT02789020
(ClinicalTrials.gov)
December 201620/5/2016Image Parkinson's Disease Progression StudyImage Parkinson's Disease Progression StudyParkinson's DiseaseDrug: Rasagiline;Other: Placebo;Device: Magnetic Resonance Imaging;Device: functional Magnetic Resonance Imaging;Other: Physical Function Performance TestUniversity of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting40 Years77 YearsAll96Phase 2United States
270NCT03000569
(ClinicalTrials.gov)
November 30, 201628/11/2016A Study to Evaluate SAGE-217 in Participants With Parkinson's DiseaseA Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s)Sage TherapeuticsNULLCompleted40 Years75 YearsAll29Phase 2United States
271EUCTR2016-002033-30-FR
(EUCTR)
29/11/201612/01/2017A 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 fluctuationsA 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.NULLNot 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): noUnited States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
272EUCTR2016-001403-23-SK
(EUCTR)
29/11/201607/09/201612-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. KGNULLNot 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): noUnited States;Hungary;European Union;Slovakia;Greece;Finland;Spain
273JPRN-UMIN000024536
2016/11/2825/10/2016Intervention 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 diseaseTreatment 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 UniversityNULLComplete: follow-up complete30years-old80years-oldMale and Female280Not applicableJapan
274EUCTR2015-004912-39-ES
(EUCTR)
25/11/201617/05/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEA 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.NULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Spain;Germany;Japan;United Kingdom
275NCT02847442
(ClinicalTrials.gov)
November 23, 201621/7/2016Efficacy and Safety of Opicapone in Clinical PracticeEfficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor FluctuationsParkinson's Disease With Wearing-off Motor FluctuationsDrug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitorBial - Portela C S.A.NULLCompleted30 YearsN/AAll518Phase 4Germany
276NCT03007888
(ClinicalTrials.gov)
November 14, 20166/12/2016A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseA Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: IR CD-LD;Drug: ER CD-LDImpax Laboratories, LLCNULLCompleted40 Years100 YearsAll28Phase 2United States
277EUCTR2016-001403-23-ES
(EUCTR)
14/11/201615/11/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn 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. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
278EUCTR2016-000657-12-SE
(EUCTR)
09/11/201612/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
279NCT03531060
(ClinicalTrials.gov)
November 8, 201610/4/2018A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA 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 DiseaseDrug: IRL790;Drug: PlaceboIntegrative Research Laboratories ABNULLCompleted50 Years85 YearsAll15Phase 1/Phase 2NULL
280EUCTR2016-001762-29-IT
(EUCTR)
08/11/201625/05/2017A 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Italy
281JPRN-UMIN000025638
2016/11/0116/01/2017Adenosine A2A receptors in Parkinson's disease Parkinson's disease11C-preladenant-PET scanningTokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete40years-old89years-oldMale and Female40Not selectedJapan
282NCT03022799
(ClinicalTrials.gov)
November 201627/12/2016Phase I, KM-819 in Healthy Subjects for Parkinson's DiseaseA 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 SubjectsParkinson's DiseaseDrug: KM-819;Drug: PlaceboKainos Medicine Inc.NULLCompleted19 Years45 YearsAll88Phase 1Korea, Republic of
283NCT02857244
(ClinicalTrials.gov)
November 201625/7/2016A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsA Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsParkinson's DiseaseDrug: Duloxetine;Drug: Donepezil;Drug: ModafinilUniversity of ChicagoNULLWithdrawn18 Years100 YearsAll0Phase 2United States
284NCT02968433
(ClinicalTrials.gov)
November 201614/11/2016The Stanford Parkinson's Disease Plasma StudyThe Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's DiseaseParkinson Disease(PD)Drug: Infusions of young plasmaStanford UniversityNULLActive, not recruiting50 Years80 YearsAll15Phase 1United States
285EUCTR2015-001786-10-DE
(EUCTR)
24/10/201607/04/2016A 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.)NULLNot 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): noUnited States;Germany;United Kingdom
286EUCTR2016-000657-12-ES
(EUCTR)
20/10/201624/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
276Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
287EUCTR2016-002680-34-ES
(EUCTR)
20/10/201605/08/2016Effects 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 NavarraNULLNot RecruitingFemale: yes
Male: yes
12Phase 4Spain
288EUCTR2015-002571-24-GB
(EUCTR)
14/10/201612/02/2019A 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 OfficeNULLNot 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): noUnited Kingdom
289EUCTR2016-002391-27-GB
(EUCTR)
07/10/201604/08/2016Opicapone 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.NULLNot 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): yesGermany;United Kingdom
290EUCTR2016-002391-27-DE
(EUCTR)
05/10/201605/08/2016OPTIPARKEfficacy 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 specifyTrade Name: Ongentys
Product Name: Ongentys
BIAL - Portela & Ca, S.A.NULLNot 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): yesGermany;United Kingdom
291EUCTR2015-005078-39-DE
(EUCTR)
21/09/201602/03/2016-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.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
292JPRN-UMIN000024312
2016/09/2025/05/2017Studies 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. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
293EUCTR2015-003679-31-NL
(EUCTR)
09/08/201624/05/2016New therapeutic strategy in Parkinson’s diseaseConservative 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 LilleNULLNot RecruitingFemale: yes
Male: yes
338Phase 2Portugal;Czech Republic;Spain;Austria;Netherlands
294NCT02789592
(ClinicalTrials.gov)
July 201631/5/2016Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson DiseaseA 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 DiseaseREM Sleep Behavior Disorder;Parkinson DiseaseDrug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placeboSeoul National University HospitalKuhnil Pharmaceutical Co., Ltd.Not yet recruiting30 YearsN/ABoth30Phase 2Korea, Republic of
295NCT02452723
(ClinicalTrials.gov)
July 201618/5/2015A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's DiseaseA 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 DiseaseParkinson DiseaseBiological: ISC-hpNSCCyto Therapeutics Pty LimitedNULLActive, not recruiting30 Years70 YearsAll12Phase 1Australia
296EUCTR2015-004344-19-FR
(EUCTR)
29/06/201620/04/2016An international trial of deferiprone in patients with parkinson’s diseaseA 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.NULLNot 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): noUnited States;France;Canada;Germany;Italy;United Kingdom
297EUCTR2015-003513-24-BG
(EUCTR)
27/06/201626/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
298EUCTR2015-005814-31-IT
(EUCTR)
23/06/201614/01/2021Not availableA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
299EUCTR2015-005626-19-CZ
(EUCTR)
23/06/201614/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 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.NULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
300EUCTR2015-003513-24-IT
(EUCTR)
23/06/201605/11/2020OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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 LTDNULLNot RecruitingFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
301EUCTR2015-003679-31-CZ
(EUCTR)
23/06/201628/01/2016New therapeutic strategy in Parkinson’s diseaseConservative 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 LilleNULLNot RecruitingFemale: yes
Male: yes
338Phase 2Portugal;Czech Republic;Spain;Austria;Netherlands
302EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
303EUCTR2015-004912-39-DE
(EUCTR)
14/06/201611/02/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEA 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.NULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Spain;Germany;Japan;United Kingdom
304EUCTR2015-005626-19-ES
(EUCTR)
13/06/201620/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 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 AcordaNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
305JPRN-jRCTs051180098
09/06/201606/03/2019The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's DiseaseA comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease Parkinson's disease;034034L-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 HidefumiNULLNot Recruiting>= 55age old< 80age oldBoth120Phase 2Japan
306EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
307EUCTR2015-005078-39-IT
(EUCTR)
08/06/201619/01/2021NAA 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.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
308EUCTR2016-000679-25-ES
(EUCTR)
31/05/201618/03/2016Clinical 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: ParapresINSTITUT DE RECERCA HSCSPNULLNot 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): noSpain
309EUCTR2015-005078-39-AT
(EUCTR)
30/05/201609/03/2016-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.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
310JPRN-UMIN000009062
2016/05/3009/10/2012An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease Parkinson's diseaseTake oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dLDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 1Japan
311EUCTR2015-003513-24-ES
(EUCTR)
18/05/201618/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
312EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
313EUCTR2016-000637-43-GB
(EUCTR)
12/05/201604/03/2016Safety, 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.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom
314EUCTR2016-000636-18-GB
(EUCTR)
12/05/201604/03/2016 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
Sunuvion Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
126 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
315JPRN-UMIN000022023
2016/05/1010/05/2016A 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 constipationStudy 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 UniversityNULLComplete: follow-up complete20years-old90years-oldMale and Female64Not selectedJapan
316JPRN-UMIN000022022
2016/05/1010/05/2016A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson diseaseA 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 constipationStudy 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 UniversityNULLComplete: follow-up complete20years-old90years-oldMale and Female64Not selectedJapan
317JPRN-UMIN000022187
2016/05/0606/05/2016Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease Parkinson&#39;s diseasePD group, 200 mg caffeine administration, qd, 1 day
Control group, 200 mg caffeine administration, qd, 1 day
Department of Neurology, Juntendo UniversityNULLComplete: follow-up complete40years-old60years-oldMale and Female20Not applicableJapan
318EUCTR2015-003887-34-PL
(EUCTR)
06/05/201626/02/2016A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
319NCT02812147
(ClinicalTrials.gov)
May 201625/5/2016Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson DiseaseEffect 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 DiseaseDrug: L-DOPS;Drug: PlaceboSt. Joseph's Hospital and Medical Center, PhoenixArizona State University, TempeActive, not recruiting30 Years83 YearsAll20Phase 2United States
320NCT02726386
(ClinicalTrials.gov)
May 201629/3/2016A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC InfusionA 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 DiseaseParkinson's DiseaseDrug: ND0612NeuroDerm Ltd.NULLActive, not recruiting30 YearsN/AAll210Phase 2United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
321NCT02705755
(ClinicalTrials.gov)
May 20167/3/2016TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic HypotensionNeurogenic 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 HypotensionDrug: TD-9855;Drug: PlaceboTheravance BiopharmaNULLCompleted40 YearsN/AAll34Phase 2United States
322EUCTR2015-003513-24-GB
(EUCTR)
28/04/201604/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
323EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
324EUCTR2015-004507-23-DE
(EUCTR)
25/04/201613/01/2016Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
325EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA 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.NULLNot 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): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
326EUCTR2015-003679-31-PT
(EUCTR)
18/04/201628/01/2016New therapeutic strategy in Parkinson’s diseaseConservative 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 LilleNULLNot RecruitingFemale: yes
Male: yes
338Phase 2Portugal;Czech Republic;Spain;Austria;Netherlands
327EUCTR2014-005630-60-AT
(EUCTR)
12/04/201604/12/2015A 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.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
328EUCTR2015-003887-34-DE
(EUCTR)
12/04/201623/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
329EUCTR2015-003679-31-AT
(EUCTR)
06/04/201611/01/2016New therapeutic strategy in Parkinson’s diseaseConservative 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 LilleNULLNot RecruitingFemale: yes
Male: yes
372Phase 2Portugal;France;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom
330EUCTR2015-005067-17-CZ
(EUCTR)
01/04/201625/01/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodesA 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.NULLNot RecruitingFemale: yes
Male: yes
345Phase 3United States;Czech Republic;Canada;Spain;Poland
331NCT04470037
(ClinicalTrials.gov)
April 201626/5/2020Multidisciplinary Study of Novel NMDA Modulation for Neurodegenerative DisorderMultidisciplinary Study of Novel NMDA Modulation for Neurodegenerative DisorderParkinson's Disease With DementiaDrug: DAAOI-P;Drug: PlaceboChina Medical University HospitalMinistry of Science and Technology, TaiwanRecruiting50 Years90 YearsAll60Phase 2Taiwan
332EUCTR2015-004344-19-GB
(EUCTR)
31/03/201616/02/2016An international trial of deferiprone in patients with Parkinson’s diseaseA 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
ApoPharmaNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
333EUCTR2015-003887-34-IT
(EUCTR)
25/03/201621/01/2021A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects with Moderate to Severe Parkinson¿s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
334EUCTR2015-001523-24-FR
(EUCTR)
25/03/201620/04/2016Evaluation 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
UHToulouseNULLNot RecruitingFemale: yes
Male: yes
75Phase 2;Phase 3France
335JPRN-jRCTs061180060
22/03/201618/03/2019Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's diseaseMulti-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;D010300Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP)Nagai MasahiroNULLRecruiting>= 20age oldNot applicableBoth100Phase 2Japan
336EUCTR2015-003679-31-ES
(EUCTR)
21/03/201613/01/2016New therapeutic strategy in Parkinson?s diseaseConservative 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 LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
338Phase 3Spain
337EUCTR2015-004507-23-LV
(EUCTR)
15/03/201613/01/2016Comparison 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Finland;Germany;Latvia
338EUCTR2015-005067-17-ES
(EUCTR)
14/03/201617/02/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodesA 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.NULLNot RecruitingFemale: yes
Male: yes
345Phase 3United States;Czech Republic;Canada;Poland;Spain
339EUCTR2015-004129-15-ES
(EUCTR)
07/03/201624/02/2016Subjects 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 progressionEvaluation 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 DisordersNULLNot RecruitingFemale: yes
Male: yes
Phase 2Spain
340EUCTR2015-003887-34-CZ
(EUCTR)
02/03/201630/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
341JPRN-UMIN000021236
2016/03/0101/03/2016Investigation in effect of aroma therapy using magnetoencepharography Normal volunteer, Epilepsy patients, Parkinson disease patientsaroma 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 NeurosurgeryNULLComplete: follow-up continuing20years-old80years-oldMale and Female10Phase 1Japan
342NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
343NCT02668497
(ClinicalTrials.gov)
March 201626/1/2016Kinematic-based BoNT-A Bilateral Upper Limb PD TherapyKinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A TherapyParkinson's DiseaseDrug: Botulinum Toxin Type AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll50Phase 2Canada
344NCT02655315
(ClinicalTrials.gov)
February 9, 20167/1/2016Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's DiseaseConservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of DeferiproneParkinson DiseaseDrug: Deferiprone;Drug: PlaceboUniversity Hospital, LilleEuropean Commission;ApoPharmaActive, not recruitingN/A80 YearsAll372Phase 2Austria;Czechia;France;Germany;Netherlands;Portugal;Spain;United Kingdom;Czech Republic
345JPRN-UMIN000020288
2016/02/0128/12/2015Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. Parkinson's diseaseIn 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 HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
346JPRN-UMIN000020527
2016/02/0101/02/2016Multi-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 diseaseInosine 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 MedicineNULLRecruiting20years-oldNot applicableMale and Female100Phase 2Japan
347EUCTR2015-004238-85-ES
(EUCTR)
27/01/201610/12/2015Brain SPECT in premotor stage of Parkinson diseaseIctal 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
IDIBAPSNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain
348EUCTR2015-003679-31-FR
(EUCTR)
25/01/201625/02/2016New therapeutic strategy in Parkinson’s diseaseConservative 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 LilleNULLNot RecruitingFemale: yes
Male: yes
338Phase 2Portugal;France;Czech Republic;Spain;Austria;Netherlands
349EUCTR2015-001786-10-GB
(EUCTR)
18/01/201623/11/2015A 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.)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
350NCT02579473
(ClinicalTrials.gov)
January 201613/10/2015A 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-214A 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 TitrationParkinson's DiseaseDrug: SER-214Serina TherapeuticsNULLActive, not recruiting40 Years80 YearsAll20Phase 1United States
351EUCTR2014-002600-24-AT
(EUCTR)
30/12/201525/09/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA 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.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
352EUCTR2014-005630-60-ES
(EUCTR)
11/12/201505/10/2015A 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.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
353EUCTR2014-002600-24-IT
(EUCTR)
11/12/201516/02/2018Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complicationsA 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 SPANULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden
354EUCTR2014-002600-24-SE
(EUCTR)
03/12/201530/07/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA 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.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
355NCT02616120
(ClinicalTrials.gov)
December 201520/11/2015Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's DiseaseEfficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease PatientsParkinson's DiseaseDrug: SQJZ herbal mixtures;Drug: PlaceboDongzhimen Hospital, BeijingNULLRecruiting18 Years80 YearsAll240Phase 2China
356EUCTR2015-002631-17-ES
(EUCTR)
19/11/201503/11/2015A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patientsAn 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 PauNULLNot 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): yesSpain
357EUCTR2014-002600-24-ES
(EUCTR)
19/11/201505/10/2015Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complicationsA 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.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
358NCT02565628
(ClinicalTrials.gov)
November 16, 201528/9/2015PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseA 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 DiseaseDrug: PF-06669571;Drug: PlaceboPfizerNULLCompletedN/AN/AAll20Phase 1United States
359JPRN-UMIN000019676
2015/11/1010/11/2015The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's diseaseThe 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 diseasetaking 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 MedicineNULLComplete: follow-up complete20years-old100years-oldMale and Female20Not selectedJapan
360EUCTR2015-000148-40-GB
(EUCTR)
09/11/201516/09/2015A 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 TrustNULLNot RecruitingFemale: yes
Male: yes
198Phase 3United Kingdom
361JPRN-UMIN000019654
2015/11/0606/11/2015The effect of rich-hydrogen water drinking to gut peptide Parkinson's disease, healthy controlhydrogen water
natural water
Nagoya graduate school of medicine universityNULLPending20years-old80years-oldMale and Female40Not applicableJapan
362JPRN-UMIN000019090
2015/11/0401/11/2015Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water Parkinson's diseasereduced 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 HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female45Not selectedJapan
363JPRN-jRCTs041180070
04/11/201507/03/2019Trerief Impact in PD PET StudyRandomized, 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 YasuomiNULLNot RecruitingNot applicable< 80age oldBoth20N/AJapan
364EUCTR2014-002600-24-GB
(EUCTR)
03/11/201528/07/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA 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.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden
365NCT04110678
(ClinicalTrials.gov)
November 1, 201518/9/2019Tolerance to NeuroEPO in Parkinson DiseaseNasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead TrialParkinson DiseaseDrug: NeuroEPOInternational Center for Neurological Restoration, CubaCenter of Molecular Immunology, Cuba;University of Electronic Science and Technology of ChinaCompleted40 Years70 YearsAll26Phase 1/Phase 2Cuba
366NCT02577523
(ClinicalTrials.gov)
November 20156/10/2015A 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 DiseaseA 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 DiseaseParkinson's DiseaseDrug: ND0612 (Levodopa/Carbidopa solution)NeuroDerm Ltd.NULLCompleted30 Years80 YearsAll38Phase 2United States;Austria;Israel;Italy
367NCT02271503
(ClinicalTrials.gov)
November 201513/10/2014A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's DiseaseA Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mgImpax Laboratories, LLCNULLCompleted40 YearsN/AAll26Phase 2United States
368NCT02758730
(ClinicalTrials.gov)
November 201526/4/2016Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA PatientsA 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-GBAParkinson's DiseaseBiological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active componentAffiris AGUniversity Hospital TuebingenWithdrawn40 Years80 YearsBoth0Phase 1Germany
369NCT02914366
(ClinicalTrials.gov)
November 20158/9/2016Ambroxol as a Treatment for Parkinson's Disease DementiaAmbroxol as a Novel Disease Modifying Treatment for Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ambroxol;Other: PlaceboLawson Health Research InstituteWeston Brain Institute;University of Western Ontario, Canada;London Health Sciences CentreRecruiting50 YearsN/AAll75Phase 2Canada
370NCT02632279
(ClinicalTrials.gov)
November 201526/11/2015Tryptophan Depletion in PD Patients Treated With STN DBSTryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor FunctionsParkinson's DiseaseDietary Supplement: Tryptophan (TRP) depletion;Dietary Supplement: Placebo;Device: Stimulator ON;Device: Stimulator OFFMaastricht University Medical CenterNetherlands Brain FoundationTerminatedN/AN/AAll7N/ANetherlands
371EUCTR2014-005630-60-DE
(EUCTR)
29/10/201507/07/2015A 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.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
372EUCTR2015-003045-26-SE
(EUCTR)
23/10/201515/09/2015Study 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Sweden
373JPRN-UMIN000019082
2015/10/1022/09/2015the effect of smell dysfunction using hydrogen gas for parkinson disease parkinson's diseasewe 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 MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female20Not selectedJapan
374JPRN-UMIN000019524
2015/10/0128/10/2015Randomized, 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) imagesRandomized, 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 DiseaseZonisamide 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 MedicineNULLComplete: follow-up completeNot applicable80years-oldMale and Female20Not applicableJapan
375EUCTR2014-005630-60-CZ
(EUCTR)
23/09/201510/07/2015A 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.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
376EUCTR2014-004865-26-IT
(EUCTR)
21/09/201529/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn 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. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88European Union;Canada;Spain;Australia;Germany;Italy;Sweden
377NCT02549092
(ClinicalTrials.gov)
September 9, 201511/9/2015A 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 StudyAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLActive, not recruiting30 Years99 YearsAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
378EUCTR2014-004865-26-DE
(EUCTR)
27/08/201522/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn 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. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3European Union;Canada;Spain;Australia;Germany;Italy;Sweden
379EUCTR2015-000373-13-DE
(EUCTR)
18/08/201518/05/2015A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s diseasePhase 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Germany;Sweden
380EUCTR2014-004865-26-SE
(EUCTR)
05/08/201525/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn 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. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
381NCT02917122
(ClinicalTrials.gov)
August 201530/6/2016The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's DiseaseThe Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's DiseaseParkinson Disease;DepressionDevice: active tDCS;Drug: Sertraline;Device: sham tDCSNational Cheng-Kung University HospitalNULLActive, not recruiting18 Years75 YearsBoth40Phase 1/Phase 2NULL
382NCT02337751
(ClinicalTrials.gov)
July 10, 20159/1/2015A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease ParticipantsA 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 LevodopaParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll198Phase 3Japan
383EUCTR2014-003738-24-AT
(EUCTR)
26/06/201501/04/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-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.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3Germany;Spain;Austria;United States
384EUCTR2014-000657-36-NL
(EUCTR)
22/06/201503/06/2015Trial to investigate the efficacy of treatments in apomorphine-induced skin reactionsOpen-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 GroningenNULLNot 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): noNetherlands
385EUCTR2014-004865-26-ES
(EUCTR)
19/06/201515/06/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn 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. KGNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEuropean Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
386EUCTR2014-003739-20-AT
(EUCTR)
19/06/201501/04/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Austria;Germany
387NCT02450786
(ClinicalTrials.gov)
June 201514/5/2015Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)Parkinson's DiseaseDrug: DonepezilYonsei UniversityNULLActive, not recruiting40 YearsN/AAll80Phase 2Korea, Republic of
388EUCTR2014-005422-35-GB
(EUCTR)
28/05/201502/04/2015The 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 TrustNULLNot 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): yesUnited Kingdom
389JPRN-jRCTs061180028
11/05/201526/02/2019Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetineA 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;D010300The 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 RinaNULLComplete20 years oldNoneBoth50Phase 2Japan
390EUCTR2014-003799-22-AT
(EUCTR)
08/05/201512/01/2015A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
391EUCTR2010-024424-26-SK
(EUCTR)
05/05/201528/04/2015Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's diseaseA 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 ScienceNULLNot 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): noFrance;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany
392NCT02439125
(ClinicalTrials.gov)
May 201513/4/2015A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease PatientsPhase 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 DiseaseParkinson's Disease;DyskinesiaDrug: Eltoprazine HCl;Drug: PlaceboAmarantus BioScience Holdings, Inc.NULLActive, not recruiting30 Years85 YearsBoth60Phase 2United States
393EUCTR2014-003738-24-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-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.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
394EUCTR2014-003739-20-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-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.NULLNot 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): noFrance;United States;Spain;Austria;Germany
395EUCTR2014-003799-22-DE
(EUCTR)
22/04/201504/12/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
396EUCTR2014-002697-37-GB
(EUCTR)
15/04/201519/03/2015Study of Melatonin for treatment of Nocturia in PDSingle-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 LondonNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom
397EUCTR2014-003739-20-FR
(EUCTR)
10/04/201519/06/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-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.NULLNot 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): noUnited States;France;Spain;Austria;Germany
398JPRN-UMIN000017036
2015/04/0303/04/2015Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. autonomic failure such as Parkinson's diseaseblood test of Leptin and Ghrelin
blood test of Leptin and Ghrelin
Nagoya University Graduate School of MedicineNULLComplete: follow-up complete40years-oldNot applicableMale and Female50Not applicableJapan
399JPRN-UMIN000016734
2015/04/0101/04/2015The evaluation of duloxetine effect for the parkinsonism and gait freezing Parkinson's diseaseDrug ; Duloxetine
Duraion; SEP012014-AUG312016
Doseage; 20mg/day or 40mg/day
Times; one time per day P.O.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-old85years-oldMale and Female30Not selectedJapan
400JPRN-UMIN000016591
2015/04/0120/02/2015Clinical trial of balance exercise "Assist" Stroke, Parkinson disease, Osteoarthrosisuse of balance exercise assist
ordinary balance exercise
Juntendo UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not applicableJapan
401NCT02359448
(ClinicalTrials.gov)
April 20154/2/2015Melatonin for Nocturia in Parkinson's DiseaseSingle-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's DiseaseParkinson's Disease;NocturiaDrug: MelatoninUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth20Phase 2United Kingdom
402EUCTR2014-003738-24-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-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.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
403EUCTR2014-003739-20-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-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.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Spain;Austria;Germany
404EUCTR2014-003799-22-BE
(EUCTR)
16/03/201516/12/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
405JPRN-UMIN000016664
2015/03/0101/03/2015Effect of nicotine patch in Cognitive function improvement in Parkinson's disease Parkinson's diseasenicotine patchDepartment of Clinical Pharmacology and Neurology Ehime University graduated School of MedicineNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
406EUCTR2014-003799-22-CZ
(EUCTR)
26/02/201526/11/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
407JPRN-UMIN000016485
2015/02/2509/02/2015Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patientsIntravenous injection of 18F-fluoro-dopa and 11C-raclopride
PET imaging
Institute of Biomedical Research and InnovationNULLComplete: follow-up complete35years-oldNot applicableMale and Female20Not selectedJapan
408EUCTR2014-003799-22-HU
(EUCTR)
11/02/201520/11/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Romania;Germany
409NCT02337725
(ClinicalTrials.gov)
February 7, 20159/1/2015A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease PatientsA 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 LevodopaParkinson's DiseaseDrug: TVP-1012;Drug: PlaceboTakedaNULLCompleted30 Years80 YearsAll244Phase 3Japan
410EUCTR2014-003799-22-ES
(EUCTR)
02/02/201516/12/2014A 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 diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
411NCT02339064
(ClinicalTrials.gov)
February 201531/3/2014Infusion of Apomorphine: Long-term Safety StudyA 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 TherapyIdiopathic Parkinson's DiseaseDrug: apomorphine infusionUS WorldMeds LLCNULLActive, not recruiting30 YearsN/AAll99Phase 3United States
412EUCTR2014-003799-22-GB
(EUCTR)
15/01/201521/11/2014A 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.NULLNot 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): noSerbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
413NCT03116308
(ClinicalTrials.gov)
November 21, 201412/4/2017Effect of Food on OpicaponeEffect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
414NCT02278588
(ClinicalTrials.gov)
November 201428/10/2014Effect 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 DiseaseDrug: RasagilineThomas GuttusoNULLCompletedN/AN/AAll45United States
415NCT02281474
(ClinicalTrials.gov)
November 201427/10/2014Nilotinib in Cognitively Impaired Parkinson Disease Patients 001Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-SynucleinParkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body DiseaseDrug: NilotinibGeorgetown UniversityNULLCompleted40 Years90 YearsBoth12Phase 1United States
416NCT02168842
(ClinicalTrials.gov)
November 201418/6/2014Efficacy of Isradipine in Early Parkinson DiseasePhase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson DiseaseParkinson DiseaseDrug: Isradipine;Drug: Placebo (for Isradipine)University of RochesterNational Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study GroupCompleted30 YearsN/AAll336Phase 3United States;Canada
417NCT02240030
(ClinicalTrials.gov)
November 201411/9/2014Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA 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 DiseaseDrug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll351Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
418NCT02312232
(ClinicalTrials.gov)
November 20142/12/2014Pharmacokinetic Study in Healthy MalesPharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy MalesParkinson's DiseaseDrug: levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
419EUCTR2014-000335-17-GB
(EUCTR)
28/10/201423/07/2014Rotigotine 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 StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes
0United Kingdom
420EUCTR2014-001132-10-ES
(EUCTR)
23/10/201402/09/2014A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
421EUCTR2014-001131-36-ES
(EUCTR)
23/10/201403/09/2014A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
422EUCTR2014-002295-87-IT
(EUCTR)
13/10/201429/09/2014A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Italy
423NCT02274324
(ClinicalTrials.gov)
October 201422/10/2014Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s DiseaseDietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDietary Supplement: different dietsSheba Medical CenterTel Aviv UniversityNot yet recruiting40 Years80 YearsBoth20N/ANULL
424NCT02259049
(ClinicalTrials.gov)
October 20143/10/2014The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's DiseaseThe Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's DiseaseBlood PressureDietary Supplement: L-tyrosine;Dietary Supplement: Sugar PillNew York Institute of TechnologyNULLCompleted40 Years84 YearsBoth6Phase 0United States
425JPRN-UMIN000016893
2014/09/2201/04/2015A 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 patientsThe 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 NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Phase 2Japan
426JPRN-UMIN000014709
2014/07/0101/08/2014Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2IStudy 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 disordersThe dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging.Tokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female200Not selectedJapan
427NCT02472210
(ClinicalTrials.gov)
July 201411/6/2015The Use of Botox in Advanced Parkinson's Patients Experiencing PainA Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot StudyParkinson's DiseaseDrug: Botulinum ToxinUniversity Health Network, TorontoNULLActive, not recruiting18 YearsN/ABoth14Phase 4NULL
428EUCTR2014-000868-17-ES
(EUCTR)
26/06/201417/03/2014Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulatorsEffect 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 NavarraNULLNot RecruitingFemale: yes
Male: yes
Spain
429EUCTR2013-000980-10-DK
(EUCTR)
06/06/201409/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Austria;Denmark;Netherlands;Germany
430NCT02780895
(ClinicalTrials.gov)
May 201412/5/2016Parkinsonian Brain Repair Using Human Stem CellsHuman OK99 Allogeneic Stem Cell Transplantation for Patients With Severe Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: Human Stem CellsCelavie Bioscences, LLCHospital Angeles del PedregalActive, not recruiting18 Years75 YearsBoth8Phase 1Mexico
431EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany
432EUCTR2013-002254-70-PL
(EUCTR)
28/04/201403/02/2014Study 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.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
433EUCTR2013-003363-64-GB
(EUCTR)
03/04/201411/03/2014Trial of Exenatide for Parkinson's diseaseA 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 LondonNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom
434NCT02111122
(ClinicalTrials.gov)
April 20148/4/2014Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseA Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseSleep-wake Disturbances in Motor-phase Parkinson's DiseaseDrug: Sodium Oxybate;Drug: PlaceboChristian BaumannNULLCompleted18 Years90 YearsAll16Phase 2Switzerland
435EUCTR2013-002254-70-CZ
(EUCTR)
05/03/201402/12/2013Study 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.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
436EUCTR2013-000980-10-FR
(EUCTR)
03/03/201422/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO 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 AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
437NCT02006121
(ClinicalTrials.gov)
March 3, 201422/11/2013Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's DiseaseMulticentre,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 TreatmentParkinson's DiseaseDrug: Apomorphine hydrochloride;Drug: PlaceboBritannia Pharmaceuticals Ltd.NULLCompleted30 YearsN/AAll107Phase 3Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom
438NCT02445651
(ClinicalTrials.gov)
March 201423/1/2015Physiological Effects of Nutritional Support in Patients With Parkinson's DiseasePhysiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: Intravenous and Oral n-acetyl cysteineThomas Jefferson UniversityNULLActive, not recruiting30 Years80 YearsAll65N/AUnited States
439EUCTR2013-002254-70-DE
(EUCTR)
28/02/201419/11/2013Study 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.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
440EUCTR2013-002254-70-IT
(EUCTR)
21/02/201427/11/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
441EUCTR2013-000980-10-ES
(EUCTR)
12/02/201412/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s diseaseTOLEDO 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 AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
442EUCTR2013-000980-10-NL
(EUCTR)
06/02/201427/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Germany;Netherlands
443NCT02305316
(ClinicalTrials.gov)
February 201428/11/2014Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of OpicaponeSingle-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy VolunteersParkinson DiseaseDrug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronizedBial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
444NCT02064166
(ClinicalTrials.gov)
February 201413/2/2014Treatment 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 AtrophyParkinson Disease;Multiple System AtrophyDrug: Intranasal InsulinPeter NovakNULLCompleted18 YearsN/AAll15Phase 2United States
445EUCTR2013-002545-10-SE
(EUCTR)
08/01/201411/11/2013An 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 6162A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Sweden
446NCT02046434
(ClinicalTrials.gov)
January 201423/1/2014Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the BrainPhenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From BrainParkinson's DiseaseDrug: Glycerol PhenylbutyrateUniversity of Colorado, DenverNULLActive, not recruiting21 Years80 YearsAll40Phase 1United States
447NCT02384512
(ClinicalTrials.gov)
January 20144/3/2015Azilect® 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 DiseaseDrug: Azilect®Teva Pharma GmbHAnfomed GmbHCompleted18 YearsN/ABoth261N/AGermany
448NCT02018406
(ClinicalTrials.gov)
December 201330/10/2013Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain InjuryNeurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson DiseaseDrug: Combination injection of EPO and G-CSF;Drug: Injection of normal salineYonsei UniversityNULLActive, not recruiting20 YearsN/AAll16Phase 1/Phase 2Korea, Republic of
449NCT04044547
(ClinicalTrials.gov)
November 22, 201330/7/2019A Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA 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 InjectionsParkinson DiseaseDrug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll60Phase 1NULL
450EUCTR2012-002840-26-RO
(EUCTR)
12/11/201317/07/2014Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
451NCT01927055
(ClinicalTrials.gov)
November 201316/8/2013A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa TherapyA Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa TherapySymptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase DeficiencyDrug: Droxidopa;Drug: PlaceboChelsea TherapeuticsNULLTerminated18 YearsN/AAll61Phase 3United States
452NCT01856738
(ClinicalTrials.gov)
November 201314/5/2013Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s DiseaseCholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.Parkinson's DiseaseDrug: Rivastigmine;Drug: Placebo (for rivastigmine)VU University Medical CenterAcademisch 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 DevelopmentTerminated40 YearsN/AAll91Phase 4Netherlands
453EUCTR2011-004438-32-DE
(EUCTR)
23/10/201313/08/2013The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
70Australia;Germany;United Kingdom;Sweden
454EUCTR2013-000980-10-AT
(EUCTR)
18/10/201331/07/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
455EUCTR2011-002827-17-SK
(EUCTR)
17/09/201304/03/2013A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
456EUCTR2013-001881-40-GB
(EUCTR)
16/09/201305/08/2013Extension 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)NULLNot 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): noUnited Kingdom
457EUCTR2013-001722-25-NL
(EUCTR)
27/08/201312/08/2013Rivastigmine 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 CFVU University Medical CenterNULLNot 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): yesNetherlands
458EUCTR2011-004438-32-SE
(EUCTR)
26/08/201301/07/2013The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
70Australia;Germany;United Kingdom;Sweden
459NCT01931488
(ClinicalTrials.gov)
August 201314/8/2013124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors.The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.Parkinson Disease;Neuroendocrine TumorsOther: MIBG label with I123 or I124;Device: SPECT imagingTel-Aviv Sourasky Medical CenterNULLRecruiting18 YearsN/ABoth40Phase 2Israel
460JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET 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 SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
461EUCTR2012-001245-40-IT
(EUCTR)
05/06/201317/05/2013CLINICAL 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
NULLNot RecruitingFemale: yes
Male: yes
Italy
462NCT01765257
(ClinicalTrials.gov)
June 20138/1/2013Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center StudyEvaluation 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;ApathyDrug: AZILECT®;Drug: PlaceboUniversity Hospital, Clermont-FerrandH. 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 ParisNot yet recruiting30 Years70 YearsBoth50Phase 4France
463JPRN-UMIN000010752
2013/05/1717/05/2013A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. Parkinson's diseasedonepezilKansai Medical UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
464EUCTR2012-005822-31-IT
(EUCTR)
13/05/201320/03/2013A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Serbia;United Kingdom;Italy
465EUCTR2013-000827-15-IT
(EUCTR)
11/05/201315/03/2013LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINELATE 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, TricaseNULLNot RecruitingFemale: yes
Male: yes
Italy
466JPRN-UMIN000010596
2013/05/0101/05/2013Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo Parkinson's diseaseMemantine 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 MedicineNULLComplete: follow-up complete20years-oldNot applicableMale40Not selectedJapan
467NCT03022201
(ClinicalTrials.gov)
May 201323/11/2016Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's DiseaseTherapeutic 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 TrialParkinson's Disease,IdiopathicDrug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701Seoul National University HospitalNULLCompleted20 Years80 YearsAll40Phase 4Korea, Republic of
468EUCTR2012-002840-26-BG
(EUCTR)
26/04/201306/02/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
469EUCTR2011-002828-41-EE
(EUCTR)
23/04/201308/02/2013A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
470EUCTR2011-002827-17-EE
(EUCTR)
23/04/201308/02/2013A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
471EUCTR2012-005822-31-GB
(EUCTR)
18/04/201305/03/2013A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Serbia;Italy;United Kingdom
472JPRN-UMIN000010778
2013/04/1022/05/2013Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2 Parkinson disease5mg donepezil hydroclorideNational Hospital of UtanoNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
473JPRN-UMIN000010371
2013/04/0801/04/2013Study of zonisamide ( TRERIEF&reg; tablet 25mg ) to tremor in patients with early Parkinson's disease. Parkinson's diseaseStart 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 YamanashiNULLPendingNot applicableNot applicableMale and Female10Not selectedJapan
474EUCTR2012-002608-42-GB
(EUCTR)
07/04/201301/11/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA 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 GmbHNULLNot 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): yesFrance;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
475EUCTR2011-002828-41-SK
(EUCTR)
27/03/201304/03/2013A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
476EUCTR2012-002840-26-SI
(EUCTR)
26/03/201318/03/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
477JPRN-UMIN000009958
2013/03/0801/03/2013Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction Parkinson's diseaseDonepezil hydrochloride added to standard therapy
Placebo added to standard therapy
National Hospital Organization, Sendai-Nishitaga HospitalNULLComplete: follow-up complete55years-old75years-oldMale and Female200Not applicableJapan
478EUCTR2012-002840-26-AT
(EUCTR)
05/03/201306/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
479NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A 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 DiseaseAn 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 DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
480NCT01780467
(ClinicalTrials.gov)
March 201321/1/2013Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian PatientsRole of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.Parkinson's DiseaseBehavioral: Role of dopamineUniversity Hospital, Clermont-FerrandNULLNot yet recruiting35 Years75 YearsBoth40Phase 4France
481JPRN-UMIN000010014
2013/02/2813/02/2013Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease Parkinson's disesasehydrogen water made by "Suisosui5.0"
placebo-water (nitrogen filling water)
Juntendo University School of Medicine, NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female200Not selectedJapan
482EUCTR2012-002840-26-IT
(EUCTR)
18/02/201311/01/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GMBHNULLNot RecruitingFemale: yes
Male: yes
600Phase 4United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy
483EUCTR2012-002840-26-HU
(EUCTR)
11/02/201313/12/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
484EUCTR2012-000801-64-GB
(EUCTR)
09/02/201326/11/2012A study of the effects of medication on memory in Parkinson's DiseaseA 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 StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes
55Phase 4United Kingdom
485NCT01766128
(ClinicalTrials.gov)
February 20138/1/2013Study of Zonisamide in Early Parkinson DiseaseRandomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson DiseaseParkinson DiseaseDrug: ZonisamideMazandaran University of Medical SciencesNULLNot yet recruiting45 Years85 YearsBoth60Phase 2/Phase 3NULL
486NCT02059733
(ClinicalTrials.gov)
February 20137/2/2014Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and ParkinsonismDeveloping a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PETParkinson's DiseaseDrug: 18F-DTBZChang Gung Memorial HospitalNULLCompleted20 Years80 YearsAll72Phase 2Taiwan
487EUCTR2012-002840-26-ES
(EUCTR)
23/01/201329/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
488EUCTR2012-002608-42-HU
(EUCTR)
10/01/201312/11/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
478France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
489EUCTR2012-002608-42-DE
(EUCTR)
10/01/201326/09/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
64United States;Hungary;Slovakia;Poland;Germany;United Kingdom
490EUCTR2012-002840-26-SK
(EUCTR)
07/01/201309/03/2016Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
491JPRN-UMIN000017695
2013/01/0127/05/2015Oxybuprocaine for apraxia of lid opening in Parkinson's disease apraxia of lid opening in Parkinson's diseaseArm 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 OrganizationNULLComplete: follow-up completeNot applicableNot applicableMale and Female10Not selectedJapan
492EUCTR2012-002608-42-SK
(EUCTR)
17/12/201209/03/2016A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
478France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
493NCT01721460
(ClinicalTrials.gov)
November 201230/10/2012Effects of Dexmedetomidine on Activity in the Subthalamic NucleusEffects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation SurgeryParkinson's Disease;Deep Brain Stimulation SurgeryDrug: DexmedetomidineUniversity of Wisconsin, MadisonNULLCompleted18 Years85 YearsAll6Phase 4United States
494NCT01738191
(ClinicalTrials.gov)
November 201228/11/2012Atomoxetine 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 ImpairmentDrug: Atomoxetine;Drug: PlaceboMedical University of South CarolinaMichael J. Fox Foundation for Parkinson's ResearchCompleted35 Years75 YearsAll30Phase 2United States
495NCT01744496
(ClinicalTrials.gov)
November 20125/12/2012Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainA Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainAdvanced Idiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll68Phase 4United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of
496NCT01683253
(ClinicalTrials.gov)
November 20127/9/2012Remission of ICD by Switching Dopamine Agonist to Levodopa/CarbidopaThe 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 TherapyImpulse Control DisorderDrug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic AgonistsSandozNULLCompleted30 Years80 YearsAll150Phase 4Korea, Republic of
497NCT01723228
(ClinicalTrials.gov)
November 20125/11/2012Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's DiseaseA 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 DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted45 Years80 YearsAll170Phase 4United States
498NCT03652363
(ClinicalTrials.gov)
October 25, 201221/8/2018GDNF in ideopathicParkinsons DiseaseA 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 DiseaseIdiopathic Parkinson DiseaseDrug: glial cell line-derived neurotrophic factorNorth Bristol NHS TrustNULLCompleted35 Years75 YearsAll42Phase 2NULL
499JPRN-UMIN000009099
2012/10/0112/10/2012The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia Parkinson's diseaselidocaine injection into the external oblique
normal saline injection into the external oblique
Parkinson's disease and Movement Disorder CenterNULLRecruiting20years-oldNot applicableMale and Female10Not applicableJapan
500NCT01560754
(ClinicalTrials.gov)
October 20129/3/2012Disease-modifying Potential of Transdermal NICotine in Early Parkinson's DiseaseA 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 USAParkinson's DiseaseDrug: nicotine transdermal patchJames BOYD MDMichael 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, GermanyActive, not recruiting30 YearsN/ABoth160Phase 2United States;Germany
501NCT01796483
(ClinicalTrials.gov)
October 201213/2/2013EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PDExploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de ParkinsonParkinson DiseaseDevice: Clonidine (Catapressan);Device: Placebo 90 minutes before EEGHospices Civils de LyonNULLCompleted40 Years70 YearsAll37N/AFrance
502EUCTR2011-003866-34-GB
(EUCTR)
24/09/201201/05/2012Assessing 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)NULLNot 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): noUnited Kingdom
503EUCTR2011-004378-27-AT
(EUCTR)
04/09/201220/07/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
504NCT01711866
(ClinicalTrials.gov)
September 201218/10/2012A 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 DiseaseAn 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 4Advanced Idiopathic Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll87Phase 4United States;Korea, Republic of;Malaysia;Singapore;Taiwan
505EUCTR2011-004803-19-FI
(EUCTR)
16/08/201216/05/2012PET study in PD patientsA 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 ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
506EUCTR2012-000122-21-DK
(EUCTR)
10/08/201207/06/2012Improving the blood pressure regulating system in patients with parkinsons diseaseAcethylcholineesterase 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
507EUCTR2012-001530-34-NL
(EUCTR)
09/08/201209/08/2012Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s DiseaseVarenicline, 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 CenterCenter Human Drug ResearchNot RecruitingFemale: yes
Male: yes
32Phase 3Netherlands
508JPRN-UMIN000008477
2012/07/1919/07/2012Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. Parkinson diseaseSelegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.Department of Neurology, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
509JPRN-UMIN000008138
2012/07/0101/07/2012Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease Parkinson's diseaseSilodosin 8mg BIDJuntendo University School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale100Not selectedJapan
510NCT01646255
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease PatientsA 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 LevodopaIdiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: Placebo Patch;Drug: L-dopaUCB PharmaUCB Trading (Shanghai) Co. Ltd.Completed30 YearsN/AAll346Phase 3China
511EUCTR2011-003053-25-GB
(EUCTR)
18/06/201201/05/2012The 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 DepartmentNULLNot 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): noUnited Kingdom
512JPRN-JapicCTI-121880
11/6/2012Phase II clinical study in patients with Parkinson's disease not taking L-DOPAA randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA Parkinson's diseaseIntervention 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.NULL2079BOTHPhase 2NULL
513EUCTR2011-002074-23-AT
(EUCTR)
05/06/201207/05/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
514JPRN-UMIN000008057
2012/06/0106/06/2012Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease Parkinson's DiseaseDaily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.St. Mariannna University School of MedicineNULLComplete: follow-up complete35years-old80years-oldMale and Female25Not applicableJapan
515NCT01993680
(ClinicalTrials.gov)
June 201227/4/2012Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -TreatmentA 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 DiseaseAutonomic Disturbances in Parkinson's DiseaseDrug: Pyridostigmine bromide;Drug: fludrocortisoneChristian BaumannNULLCompleted50 Years80 YearsAll18Phase 2Switzerland
516NCT02786667
(ClinicalTrials.gov)
June 201218/5/2016Non Motors Aspects in De Novo Parkinson's DiseaseNon Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.Parkinson Disease;ApathyDrug: Rotigotine;Drug: PlaceboUniversity Hospital, GrenobleNULLActive, not recruiting30 Years72 YearsAll199Phase 3France
517EUCTR2011-004378-27-DE
(EUCTR)
15/05/201224/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
518EUCTR2011-004378-27-SK
(EUCTR)
02/05/201212/04/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
519JPRN-UMIN000007896
2012/05/0107/05/2012Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes Parkinson's disease and other parkinsonian syndromesThe 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 UniversityNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
520EUCTR2012-000181-37-GB
(EUCTR)
25/04/201227/02/2012A study investigating the safety of CVT-301 in patients with Parkinson's DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Israel;United Kingdom
521EUCTR2011-004438-32-GB
(EUCTR)
25/04/201218/04/2012The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA 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 LimitedNULLNot 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): noGermany;United Kingdom;Sweden
522EUCTR2011-001092-39-IT
(EUCTR)
19/04/201220/06/2012efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson's patients with moderate to severe L-dopa induced dyskinesiasA 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 FARMANULLNot RecruitingFemale: yes
Male: yes
72United States;Germany;Italy
523EUCTR2011-005839-91-ES
(EUCTR)
02/04/201211/01/2012Gabapentin 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 BIODONOSTIANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Spain
524JPRN-UMIN000007617
2012/04/0130/03/2012Effect of lidocaine injection for postural deformities in Parkinson's disease Parkinson's diseaseintramuscular injection of lidocaineDept. of Clinical pharmacology and Neurology, Ehime UniversityNULLRecruiting20years-old80years-oldMale and Female30Not selectedJapan
525NCT01491529
(ClinicalTrials.gov)
April 201212/12/2011Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsAll154Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
526NCT01556165
(ClinicalTrials.gov)
April 201213/3/2012Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaParkinson's DiseaseDrug: rasagiline;Drug: placeboH. Lundbeck A/SNULLCompleted35 YearsN/AAll130Phase 3China
527EUCTR2011-002074-23-ES
(EUCTR)
30/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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.NULLNot RecruitingFemale: yes
Male: yes
92France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
528EUCTR2011-004378-27-HU
(EUCTR)
28/03/201215/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Canada;Spain;Austria;Germany;Italy
529EUCTR2011-002074-23-SK
(EUCTR)
28/03/201230/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 AGNULLNot RecruitingFemale: yes
Male: yes
92United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
530EUCTR2011-004378-27-IT
(EUCTR)
27/03/201202/03/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn 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 FARMANULLNot RecruitingFemale: yes
Male: yes
65United States;Hungary;Canada;Spain;Austria;Germany;Italy
531EUCTR2011-002074-23-HU
(EUCTR)
21/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
532EUCTR2011-002074-23-DE
(EUCTR)
20/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 AGNULLNot RecruitingFemale: yes
Male: yes
140France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
533EUCTR2011-002074-23-IT
(EUCTR)
15/03/201202/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-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 FARMANULLNot RecruitingFemale: yes
Male: yes
92United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
534EUCTR2011-002901-31-DE
(EUCTR)
08/03/201206/10/2011not applicableA 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. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
535NCT02039024
(ClinicalTrials.gov)
March 201215/1/2014Imaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PETImaging Non-motor Symptoms of Parkinson's Disease by Novel 18F-DTBZ and Florbetapir F-18 PETParkinson's DiseaseDrug: 18F- DTBZChang Gung Memorial HospitalNational Science Council, TaiwanCompleted20 Years80 YearsBoth18Phase 2Taiwan
536NCT01491932
(ClinicalTrials.gov)
March 20121/12/2011Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll129Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
537EUCTR2011-004803-19-SE
(EUCTR)
22/02/201216/12/2011PET study in PD patientsA 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 ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
538EUCTR2011-005054-59-RO
(EUCTR)
21/02/201213/06/2013SYN115 in Parkinson’s diseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
400United States;Canada;Argentina;Ukraine;Romania;Chile
539NCT01673724
(ClinicalTrials.gov)
February 201223/8/2012Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's DiseaseEffect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized StudyParkinson's DiseaseDrug: pramipexole;Drug: BromocriptineSandozNULLCompleted30 YearsN/AAll121Phase 4Korea, Republic of
540EUCTR2009-015170-35-GB
(EUCTR)
27/01/201221/12/2011Study 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 TrustNULLNot 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): noUnited Kingdom
541NCT01515410
(ClinicalTrials.gov)
January 201211/1/2012Study in Advanced Parkinson's Disease Patients With Predictable Motor FluctuationsA 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 FluctuationsParkinson's Disease;Motor FluctuationsDrug: DM-1992;Drug: Sinemet IRDepomedNULLCompleted30 YearsN/AAll34Phase 2United States
542EUCTR2011-002901-31-HU
(EUCTR)
21/12/201113/10/2011not applicableA 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. KGNULLNot RecruitingFemale: yes
Male: yes
210Czech Republic;Hungary;Spain;Germany;United Kingdom
543EUCTR2009-017412-32-IT
(EUCTR)
13/12/201127/04/2010RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - NDRANDOMISED 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.SALESINULLNot RecruitingFemale: yes
Male: yes
Italy
544EUCTR2011-002901-31-CZ
(EUCTR)
12/12/201110/10/2011not applicableA 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. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
545EUCTR2011-002901-31-ES
(EUCTR)
30/11/201105/10/2011not applicableA 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. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Hungary;Czech Republic;Spain;Germany;United Kingdom
546EUCTR2011-002901-31-GB
(EUCTR)
25/11/201121/09/2011A 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 painA 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. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Hungary;Czech Republic;Spain;Germany;United Kingdom
547EUCTR2009-015162-57-NL
(EUCTR)
21/11/201111/05/2011An 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.NULLNot 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): noUnited 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
548EUCTR2011-002073-30-IT
(EUCTR)
14/11/201106/03/2012Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-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 FARMANULLNot RecruitingFemale: yes
Male: yes
63United States;European Union;Canada;Spain;Germany;Switzerland;Italy
549EUCTR2009-015162-57-PT
(EUCTR)
04/11/201112/08/2011An 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., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
550NCT01736891
(ClinicalTrials.gov)
November 201127/11/2012Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor FluctuationsEvaluation 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 DiseaseDrug: Rasagiline;Drug: PlaceboChongqing Fortune Pharmaceutical Co., Ltd.Beijing Bionovo Medicine Development Co., Ltd.Completed30 Years75 YearsBoth268Phase 3China
551NCT01291537
(ClinicalTrials.gov)
November 20117/2/2011Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease PatientsParkinson's DiseaseDrug: Duodopa;Drug: best médical treatmentPoitiers University HospitalNULLCompleted18 Years80 YearsBoth56Phase 2France
552NCT01385592
(ClinicalTrials.gov)
November 201128/6/2011Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-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 DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian DisordersDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsBoth78Phase 2United States;Canada;France;Germany;Hungary;Italy;Spain
553NCT01556100
(ClinicalTrials.gov)
November 20116/3/2012Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionLong-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionParkinson DiseaseDrug: 18F-DTBZ AV-133Chang Gung Memorial HospitalNULLCompleted20 YearsN/AAll40Phase 2NULL
554NCT01457807
(ClinicalTrials.gov)
November 201110/10/2011To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersA 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 VolunteersParkinson's DiseaseDrug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AstraZenecaNULLCompleted30 Years65 YearsBoth24Phase 1United Kingdom
555EUCTR2009-015162-57-PL
(EUCTR)
25/10/201130/08/2011An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
556EUCTR2011-000056-42-GB
(EUCTR)
07/10/201111/08/2011Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's diseaseA 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 SANULLNot RecruitingFemale: yes
Male: yes
United Kingdom
557JPRN-UMIN000006521
2011/10/0111/10/2011Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's diseaseSwitch 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 diseaseRapid 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 UniversityNULLRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
558NCT01385735
(ClinicalTrials.gov)
October 201128/6/2011Emotion, Mood and Executive Function in Parkinson`s Disease (PD)Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s DiseaseParkinson DiseaseDrug: Rasagiline;Drug: PlaceboSt. Josef Hospital BochumNULLNot yet recruiting30 Years75 YearsBoth70Phase 4Germany
559NCT02427646
(ClinicalTrials.gov)
October 201122/4/2015Kinematic-guided BoNT-A Treatment for ET and PD TremorUse of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson DiseaseTremorDrug: BoNT-AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll54Phase 2NULL
560EUCTR2010-018534-44-CZ
(EUCTR)
23/09/201104/07/2011Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA 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 plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
561EUCTR2009-015162-57-IT
(EUCTR)
22/09/201127/04/2011A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - NDA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden
562NCT01474421
(ClinicalTrials.gov)
September 15, 20115/10/2011Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseA 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 DyskinesiasDyskinesias;Drug-inducedDrug: AQW051;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll71Phase 2United States;France;Germany;Italy
563EUCTR2011-001148-31-GB
(EUCTR)
13/09/201117/08/2011A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1 Parkinson's diseaseTrade Name: Ferrprox (Deferiprone)
Product Name: Deferiprone (Ferriprox)
INN or Proposed INN: Deferiprone
Imperial College LondonNULLNot 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): noUnited Kingdom
564EUCTR2010-020299-42-DE
(EUCTR)
30/08/201126/04/2011A 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 MarburgNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Germany
565EUCTR2010-018534-44-HU
(EUCTR)
30/08/201108/07/2011Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA 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 plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2France;United States;Serbia;Czech Republic;Hungary;Canada;Poland;Romania;Germany;United Kingdom
566EUCTR2009-015162-57-GB
(EUCTR)
16/08/201126/01/2011An 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.NULLNot 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): noUnited 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
567EUCTR2010-021394-37-BG
(EUCTR)
04/08/201102/06/2011Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
568EUCTR2009-015162-57-BG
(EUCTR)
04/08/201109/06/2011An 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.NULLNot 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): noUnited 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
569EUCTR2010-021860-13-BG
(EUCTR)
04/08/201102/06/2011EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
570NCT01759888
(ClinicalTrials.gov)
August 20111/1/2013Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 ParkinsonismFrom Mouse Models to Patients: Development of a Novel 18F-DTBZ PET Imaging as a Biomarker to Monitor Neurodegeneration of PARK6 and PARK8 ParkinsonismParkinson's DiseaseDrug: 18F-DTBZChang Gung Memorial HospitalNational Science Council, TaiwanCompleted20 Years80 YearsBoth49Phase 2Taiwan
571EUCTR2010-021860-13-IT
(EUCTR)
25/07/201129/03/2012EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina
572EUCTR2009-015162-57-LT
(EUCTR)
25/07/201121/04/2011An 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 CorporationNULLNot 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): noUnited 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
573EUCTR2009-015162-57-LV
(EUCTR)
19/07/201111/05/2011An 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 CorporationNULLNot 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): noSerbia;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
574EUCTR2010-023756-82-DE
(EUCTR)
13/07/201128/04/2011Study to test influence of parkinson drug of insomnia in parkinson patientsRasagiline 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 TechnologyNULLNot RecruitingFemale: yes
Male: yes
Germany
575EUCTR2009-015162-57-SE
(EUCTR)
12/07/201131/05/2011An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
576EUCTR2011-001092-39-DE
(EUCTR)
29/06/201117/05/2011efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesiasA 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 AGNULLNot RecruitingFemale: yes
Male: yes
72France;United States;Germany;Italy
577EUCTR2010-020112-11-LT
(EUCTR)
29/06/201106/04/2011Placebo 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia
578EUCTR2010-021860-13-CZ
(EUCTR)
24/06/201109/11/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
579EUCTR2010-022200-46-LV
(EUCTR)
21/06/201101/04/2011Efficacy 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
580EUCTR2010-020112-11-LV
(EUCTR)
21/06/201108/04/2011Placebo 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia
581EUCTR2009-015162-57-CZ
(EUCTR)
17/06/201115/04/2011An 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 CorporationNULLNot 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): noArgentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden;Canada;Mexico;Czech Republic;United Kingdom;Austria;Turkey;Lithuania;Finland;Latvia;Netherlands;South Africa;Peru;France;India;Italy;Colombia;Chile;Russian Federation;Israel;Ukraine;Spain;Portugal;Serbia;United States
582EUCTR2009-015161-31-PL
(EUCTR)
08/06/201123/02/2011A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
583EUCTR2009-013552-72-PL
(EUCTR)
08/06/201123/02/2011A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United 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
584NCT01652534
(ClinicalTrials.gov)
June 201115/8/2011Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's DiseaseEfficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Amantadine;Drug: PlaceboNorthwestern UniversityNULLTerminated18 Years85 YearsAll3Phase 3United States
585NCT01528592
(ClinicalTrials.gov)
June 201131/1/2012PharmacoMRI of Parkinson DiseaseA Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's DiseaseParkinson's DiseaseDrug: Carbidopa-LevodopaNorthwestern UniversityNULLCompleted30 YearsN/AAll18N/AUnited States
586EUCTR2010-022517-25-DE
(EUCTR)
30/05/201114/02/2011Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's diseasePhase 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 SANULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Austria;Germany
587EUCTR2008-005492-94-BG
(EUCTR)
25/05/201123/03/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United 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
588EUCTR2009-015162-57-ES
(EUCTR)
23/05/201131/03/2011Estudio 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 CorporationNULLNot 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): noPortugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden
589EUCTR2010-021394-37-AT
(EUCTR)
19/05/201105/01/2011Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
590EUCTR2010-022200-46-FI
(EUCTR)
13/05/201123/03/2011Efficacy 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Germany;Latvia;Lithuania
591EUCTR2010-022200-46-LT
(EUCTR)
09/05/201105/04/2011Efficacy 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
592EUCTR2007-002964-90-BE
(EUCTR)
05/05/201104/09/2007A 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 SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United 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
593EUCTR2010-021394-37-SK
(EUCTR)
02/05/201116/12/2010Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
594NCT01856439
(ClinicalTrials.gov)
May 201114/5/2013Long Term Safety and Efficacy Study of ProSavin in Parkinson's DiseaseA Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: ProSavinAxovant Sciences Ltd.Oxford BioMedicaActive, not recruitingN/AN/AAll15Phase 1/Phase 2France;United Kingdom
595NCT01504178
(ClinicalTrials.gov)
May 201130/12/2011Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseEvaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's DiseaseParkinson's DiseaseDrug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-DopaUniversity Hospital, ToulouseFrench Parkinson AssociationCompleted30 Years70 YearsAll28Phase 3France
596EUCTR2010-022366-27-CZ
(EUCTR)
21/04/201123/11/2010BIPARK STUDY IIEfficacy 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.NULLNot RecruitingFemale: yes
Male: yes
405Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
597EUCTR2010-022366-27-BE
(EUCTR)
18/04/201101/02/2011Efficacy 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 IIEfficacy 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.NULLNot RecruitingFemale: yes
Male: yes
405Phase 3Czech Republic;Estonia;Belgium;United Kingdom
598EUCTR2010-022517-25-AT
(EUCTR)
15/04/201117/02/2011Phase 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 diseasePhase 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 SANULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Austria;Germany
599EUCTR2008-005492-94-PT
(EUCTR)
14/04/201119/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Finland;Korea, Republic of;Netherlands;South Africa;Peru;Malaysia;France;India;Italy;Switzerland;Colombia;Chile;Spain;Thailand;Slovakia;Estonia;Taiwan;Portugal;United States
600EUCTR2009-015161-31-DE
(EUCTR)
04/04/201124/08/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
601NCT01313819
(ClinicalTrials.gov)
April 201110/3/2011The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyA Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyParkinson`s Disease;Freezing of GaitDrug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml injSeoul National University HospitalNULLRecruiting30 Years80 YearsBoth20Phase 4Korea, Republic of
602EUCTR2009-013552-72-BG
(EUCTR)
24/03/201126/01/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United 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
603EUCTR2010-022366-27-GB
(EUCTR)
23/03/201130/11/2010BIPARK STUDY IIEfficacy 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.NULLNot RecruitingFemale: yes
Male: yes
405Phase 3Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
604EUCTR2009-015162-57-AT
(EUCTR)
17/03/201103/02/2011An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United 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
605EUCTR2008-005492-94-CZ
(EUCTR)
14/03/201103/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;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
606EUCTR2010-018534-44-DE
(EUCTR)
11/03/201110/08/2010Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA 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 plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
607EUCTR2010-021860-13-DE
(EUCTR)
09/03/201118/10/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
608EUCTR2010-021394-37-CZ
(EUCTR)
09/03/201114/12/2010Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland
609EUCTR2010-021394-37-DE
(EUCTR)
08/03/201103/12/2010Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
610EUCTR2009-013552-72-GB
(EUCTR)
07/03/201107/07/2010A 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., IncNULLNot 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): noUnited 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
611EUCTR2009-015161-31-GB
(EUCTR)
07/03/201101/07/2010A 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.NULLNot 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): noPortugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
612EUCTR2008-005492-94-FI
(EUCTR)
04/03/201113/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;New Zealand;Germany;Bulgaria;Croatia;Romania;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom
613EUCTR2009-015162-57-FI
(EUCTR)
02/03/201120/01/2011An 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 CorporationNULLNot 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): noUnited 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
614EUCTR2010-021394-37-IT
(EUCTR)
01/03/201128/12/2011STUDIO 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 - SP0976STUDIO 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 SANULLNot RecruitingFemale: yes
Male: yes
345Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy
615NCT01330290
(ClinicalTrials.gov)
March 201118/3/2011Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver SupportA 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 SupportIdiopathic Parkinson's DiseaseDrug: Neupro®UCB PharmaNULLCompleted18 YearsN/AAll148N/AGermany
616NCT01294800
(ClinicalTrials.gov)
February 25, 201110/2/2011A 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 DiseaseDrug: Preladenant;Drug: Placebo tablet to match PreladenantMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll450Phase 2Japan
617EUCTR2008-001329-33-GB
(EUCTR)
24/02/201115/03/2010Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-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 IncNULLNot 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): noPortugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom
618EUCTR2010-021860-13-SK
(EUCTR)
17/02/201109/12/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
619EUCTR2010-021394-37-ES
(EUCTR)
17/02/201122/12/2010Estudio 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) - SP0976Estudio 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Slovakia;Belgium;Spain;Austria;Bulgaria;Germany;Italy
620EUCTR2009-015161-31-BG
(EUCTR)
17/02/201102/02/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
621EUCTR2010-021394-37-HU
(EUCTR)
14/02/201113/12/2010Multicenter, 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 diseaseMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
622EUCTR2009-017174-20-AT
(EUCTR)
09/02/201107/12/2010A 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
24Germany;Canada;France;Austria;South Africa
623NCT01300819
(ClinicalTrials.gov)
February 201118/2/2011Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor SymptomsMulticenter, 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 DiseaseIdiopathic Parkinson's DiseaseOther: Placebo;Drug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll349Phase 4Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland
624EUCTR2009-015161-31-PT
(EUCTR)
28/01/201129/10/2010A 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., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
625EUCTR2010-021860-13-AT
(EUCTR)
27/01/201111/10/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina
626EUCTR2010-021860-13-RO
(EUCTR)
27/01/201125/07/2011EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Phase 3Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
627EUCTR2010-021394-37-BE
(EUCTR)
25/01/201114/12/2010Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, 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 SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
628EUCTR2010-021860-13-ES
(EUCTR)
24/01/201127/10/2010EFFICACY 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 IEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
629EUCTR2009-013552-72-CZ
(EUCTR)
17/01/201128/07/2010A 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 CorporationNULLNot 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): noUnited 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
630EUCTR2009-015161-31-CZ
(EUCTR)
17/01/201128/07/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
631EUCTR2010-022915-21-SE
(EUCTR)
12/01/201118/11/2010Duration 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 - PARTESTDuration 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
632EUCTR2010-022915-21-FI
(EUCTR)
10/01/201111/11/2010Duration 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 - PARTESTDuration 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
633NCT01340885
(ClinicalTrials.gov)
January 201119/4/2011Cognitive Decline in Non-demented PDCognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot StudyParkinson's DiseaseDrug: Strattera;Drug: Exelon;Other: PlaceboOregon Health and Science UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed18 YearsN/AAll9Phase 4United States
634EUCTR2010-021860-13-LV
(EUCTR)
22/12/201014/10/2010EFFICACY 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 IEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
635EUCTR2010-021860-13-PT
(EUCTR)
22/12/201008/11/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
636EUCTR2008-004146-88-DE
(EUCTR)
20/12/201015/10/2010An 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 agonistA 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Germany;Bulgaria;South Africa;Peru;Croatia;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;India;Italy;Colombia;Chile;Spain;Finland;Slovakia;United States;Portugal
637EUCTR2010-022366-27-EE
(EUCTR)
10/12/201003/11/2010Efficacy 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 IIEfficacy 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.NULLNot RecruitingFemale: yes
Male: yes
405Czech Republic;Estonia;Belgium;United Kingdom
638EUCTR2009-015161-31-NL
(EUCTR)
09/12/201009/08/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India
639EUCTR2009-015161-31-IT
(EUCTR)
06/12/201028/09/2010 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 CorporationNULLNot 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): noPortugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
640EUCTR2009-013552-72-IT
(EUCTR)
06/12/201004/11/2010A 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) - NDA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden
641EUCTR2009-013552-72-SE
(EUCTR)
02/12/201006/10/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United 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
642EUCTR2009-015161-31-SE
(EUCTR)
02/12/201006/10/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
643NCT01244269
(ClinicalTrials.gov)
December 201018/11/2010The 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 DiseaseDrug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20Laval UniversityFonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research CenterTerminatedN/A75 YearsBoth6Phase 4Canada
644EUCTR2010-021860-13-LT
(EUCTR)
30/11/201028/09/2010EFFICACY 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 STUDYEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina
645EUCTR2010-020109-34-ES
(EUCTR)
29/11/201023/09/2010Estudio 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. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain;Italy
646EUCTR2010-020109-34-IT
(EUCTR)
24/11/201027/12/2010A 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. - NDA 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 SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain;Italy
647NCT01227265
(ClinicalTrials.gov)
November 19, 201022/10/2010Placebo 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 DiseaseDrug: Preladenant;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll476Phase 3Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States
648NCT01215227
(ClinicalTrials.gov)
November 18, 20104/10/2010An 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 DiseaseDrug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagilineMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll839Phase 3Argentina;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
649EUCTR2010-021860-13-HU
(EUCTR)
11/11/201027/09/2010EFFICACY 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 IEFFICACY 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.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
650EUCTR2007-001109-26-GB
(EUCTR)
04/11/201005/08/2010A 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 diseaseA 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 DiseaseProduct Name: ProSavin
INN or Proposed INN: ProSavin
Oxford BioMedica (UK) LtdNULLNot 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): noUnited Kingdom
651EUCTR2009-015161-31-AT
(EUCTR)
03/11/201017/08/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
652NCT01060878
(ClinicalTrials.gov)
November 20101/2/2010Investigation 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 WeeksParkinson's DiseaseDrug: PYM50028;Drug: PlaceboPhytopharmNULLCompleted35 Years75 YearsBoth425Phase 2United States;Canada;Czech Republic;France;Germany;Hungary;Poland;Romania;Serbia;United Kingdom
653NCT01190553
(ClinicalTrials.gov)
November 201026/8/2010Pilot Study of Maintenance Therapy With Intravenous AMANTADINEMaintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson MedicationsParkinson DiseaseDrug: AmantadineRabin Medical CenterNULLNot yet recruiting30 Years80 YearsBoth20N/ANULL
654NCT01270711
(ClinicalTrials.gov)
November 20109/12/2010Study 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;HyperprolactinemiaDrug: Study DrugPfizerNULLCompletedN/AN/AAll22014N/ANULL
655EUCTR2009-013552-72-ES
(EUCTR)
26/10/201027/07/2010Estudio 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) - PARADYSEEstudio 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 ResearchNULLNot 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): noHungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
656EUCTR2010-018534-44-GB
(EUCTR)
22/10/201009/08/2010Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA 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 plcNULLNot 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): noFrance;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
657EUCTR2009-013552-72-HU
(EUCTR)
21/10/201011/08/2010A 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 - MonotherapyA 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 diseaseProduct 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
658EUCTR2009-015161-31-FR
(EUCTR)
19/10/201029/07/2010A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's DiseaseA 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 CorporationNULLNot 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): noPortugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
659EUCTR2009-015928-28-SE
(EUCTR)
07/10/201013/08/2010A 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. - ELTODYS09A 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 diseaseProduct Name: Eltoprazine HCl
Product Code: Eltoprazine HCl
PsychoGenics IncNULLNot RecruitingFemale: yes
Male: yes
24Sweden
660EUCTR2007-002964-90-CZ
(EUCTR)
06/10/201027/08/2010A 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 levodopaA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
605Phase 3Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria
661EUCTR2010-019418-25-DE
(EUCTR)
01/10/201019/07/2010Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
244France;Canada;Finland;Australia;Germany;Italy;Japan
662NCT01173731
(ClinicalTrials.gov)
October 201028/7/2010Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasParkinson Disease;Dyskinesia, Drug-Induced;LevodopaDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll66Phase 2United States;Australia;Canada;France;Germany;Italy;Finland;Spain
663EUCTR2010-019418-25-FR
(EUCTR)
29/09/201015/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
664EUCTR2009-017238-39-DE
(EUCTR)
16/09/201028/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s DiseaseA 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)NULLNot RecruitingFemale: yes
Male: yes
96Phase 3France;Belgium;Germany;Italy
665EUCTR2009-017238-39-FR
(EUCTR)
15/09/201009/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA 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)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
666EUCTR2010-019418-25-FI
(EUCTR)
08/09/201021/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
667EUCTR2009-013552-72-FI
(EUCTR)
07/09/201002/07/2010A 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 CorporationNULLNot 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): noUnited 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
668NCT01211587
(ClinicalTrials.gov)
September 201028/9/2010A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's DiseaseA 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 ImpairmentParkinson's Disease With Cognitive ImpairmentsDrug: safinamide;Drug: placeboNewronNULLCompleted45 Years80 YearsBoth103Phase 2United States;Spain
669EUCTR2009-017238-39-BE
(EUCTR)
27/08/201014/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA 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)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
670EUCTR2009-015161-31-FI
(EUCTR)
17/08/201023/06/2010A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
671EUCTR2009-017182-38-ES
(EUCTR)
26/07/201025/05/2010Estudio 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Estonia;Poland;Spain;Lithuania;Germany;Latvia
672NCT01155466
(ClinicalTrials.gov)
July 14, 201030/6/2010A 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 DiseaseDrug: 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 capsuleMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll778Phase 3Austria;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
673EUCTR2010-018650-12-FR
(EUCTR)
13/07/201006/05/2010Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOXEvaluation 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 ToulouseNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
674EUCTR2009-017182-38-LT
(EUCTR)
10/07/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn 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)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
675EUCTR2009-017182-38-DE
(EUCTR)
09/07/201007/05/2010An 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 DivisionNULLNot RecruitingFemale: yes
Male: yes
500Estonia;Spain;Poland;Lithuania;Latvia;Germany
676EUCTR2009-017182-38-PL
(EUCTR)
07/07/201020/05/2010An 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.NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
677NCT01174810
(ClinicalTrials.gov)
July 20102/8/2010Exendin-4 as a Treatment for Parkinson's Disease - Pilot StudyAn 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 DiseaseDrug: ExenatideUniversity College, LondonNULLActive, not recruiting45 Years70 YearsBoth40Phase 2United Kingdom
678EUCTR2009-017238-39-IT
(EUCTR)
21/06/201013/07/2010A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
56Germany;France;Italy
679EUCTR2009-017182-38-LV
(EUCTR)
11/06/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn 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)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
680EUCTR2009-013886-24-SE
(EUCTR)
08/06/201021/12/2009Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s diseaseA 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
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Czech Republic;Germany;Sweden
681NCT01176240
(ClinicalTrials.gov)
June 201030/7/2010A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's DiseaseA 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 DiseaseOrthostatic Hypotension;Parkinson's DiseaseDrug: Droxidopa;Other: PlaceboChelsea TherapeuticsNULLCompleted18 YearsN/AAll225Phase 3United States
682NCT01141023
(ClinicalTrials.gov)
June 20108/6/2010Study to Identify Clinical, Imaging and Biologic Markers of Parkinson Disease ProgressionThe Parkinson's Progression Markers Initiative (PPMI)Parkinson DiseaseDrug: DaTscanKen Marek, MDInstitute for Neurodegenerative DisordersActive, not recruiting30 YearsN/AAll1100Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Norway;Spain;United Kingdom
683EUCTR2009-016143-19-AT
(EUCTR)
26/05/201012/05/2010Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte StudieValidierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie Parkinson's diseaseTrade Name: Amantadin-ratiopharm 100mg
Other descriptive name: AMANTADINE HYDROCHLORIDE
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
66France;Austria
684EUCTR2010-019354-40-AT
(EUCTR)
26/05/201026/04/2010Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem ParkinsonsyndromÜberprüfung 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 InnsbruckNULLNot RecruitingFemale: yes
Male: yes
15Austria
685EUCTR2009-017182-38-EE
(EUCTR)
14/05/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn 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)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
686JPRN-UMIN000003601
2010/05/0118/05/2010Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients Parkinson's diseaseIncrease dosage of ropinirole
Addition of entacapone
Kansai Medical UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female30Not selectedJapan
687EUCTR2009-018137-37-GB
(EUCTR)
14/04/201018/03/2010An 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 trialAn 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 LondonNULLNot 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): noUnited Kingdom
688NCT00988117
(ClinicalTrials.gov)
April 201029/9/2009The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking ProblemsThe 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 ProblemsDrug: Rivastigmine Patch 9.5 cm2University of California, San FranciscoNovartisCompleted55 YearsN/AAll15Phase 4United States
689EUCTR2009-017174-20-DE
(EUCTR)
15/03/201007/01/2010A 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
24France;Canada;Austria;South Africa;Germany
690EUCTR2009-013886-24-DE
(EUCTR)
03/03/201029/10/2009A 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-2A 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
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Czech Republic;Germany;Sweden
691NCT01055379
(ClinicalTrials.gov)
March 201022/1/2010Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOnA 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 StudyDepressive Symptoms;Parkinson's DiseaseDrug: Rasagiline;Drug: PlaceboLundbeck Italia S.p.A.Teva Pharmaceutical IndustriesCompleted40 Years80 YearsAll121Phase 4Italy
692NCT01092065
(ClinicalTrials.gov)
March 201022/3/2010Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced DyskinesiaA 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 DyskinesiaParkinson's DiseaseDrug: AFQ056 with L-dopa;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll23Phase 2United States
693EUCTR2009-017174-20-FR
(EUCTR)
24/02/201018/01/2010A 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
36Phase 2France;Austria;Germany
694EUCTR2007-002963-28-DE
(EUCTR)
17/02/201022/12/2009A 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 antagonistA 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 SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
695NCT01154166
(ClinicalTrials.gov)
February 15, 201029/6/2010A 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-DopaA 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-DopaParkinson DiseaseDrug: ReQuip PR;Drug: PlaceboGlaxoSmithKlineNULLCompleted30 YearsN/AAll347Phase 3China
696EUCTR2009-014688-37-PL
(EUCTR)
09/02/201020/01/2010A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/AA 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.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
697EUCTR2009-016360-37-SE
(EUCTR)
06/02/201004/12/2009TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDYTREATMENT 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 HolmbergNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
698EUCTR2008-005492-94-BE
(EUCTR)
25/01/201012/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
699EUCTR2009-017416-33-DE
(EUCTR)
18/01/201021/12/2009Standardized 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-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
700EUCTR2008-001329-33-CZ
(EUCTR)
18/01/201003/12/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-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 IncNULLNot RecruitingFemale: yes
Male: yes
275Phase 3Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy
701EUCTR2009-012643-42-NL
(EUCTR)
06/01/201030/11/2009Freezing 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 diseaseFreezing 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 GaitTrade Name: Ritalin
Product Name: Not applicable
Product Code: Not applicable
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Other descriptive name: Ritalin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
702JPRN-UMIN000003080
2010/01/0130/01/2010Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease Parkinson's diseaseDonepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks)
Placebo
Clinical Research Center, Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up complete40years-old75years-oldMale and Female30Not applicableJapan
703JPRN-UMIN000007497
2010/01/0114/03/2012Trial of molecular hydrogen water in Parkinson disease Parkinson diseaseThe 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 MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female18Not applicableJapan
704NCT01007864
(ClinicalTrials.gov)
January 20103/11/2009Influence of Piribedil (Clarium®) on Vigilance and Cognitive Function in Patients With Parkinson's Disease Compared to Other Non-Ergot Dopamine AgonistsInfluence 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 AgonistsIdiopathic Parkinson's DiseaseDrug: piribedil;Drug: pramipexole or ropiniroleDesitin Arzneimittel GmbHFGK Clinical Research GmbHCompleted35 Years80 YearsBoth80Phase 3Germany
705NCT01417598
(ClinicalTrials.gov)
January 201015/8/2011BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical ActivityImproving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.Elderly;Parkinsons Disease;OsteoporosisOther: Gait and balance group training;Other: Nordic walking (only osteoporosis group)Karolinska InstitutetThe Swedish Research CouncilActive, not recruiting60 YearsN/AAll200N/ASweden
706EUCTR2009-011541-24-NL
(EUCTR)
30/12/200929/05/2009An 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-UpAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
707EUCTR2009-014688-37-ES
(EUCTR)
30/12/200921/10/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
708EUCTR2009-014688-37-DE
(EUCTR)
15/12/200907/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
709EUCTR2008-005492-94-GB
(EUCTR)
09/12/200901/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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. - GenevaNULLNot 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): noPortugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
710EUCTR2009-012897-12-RO
(EUCTR)
08/12/200930/03/2015A 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-decarboxylaseinhibitorA 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, SANULLNot RecruitingFemale: yes
Male: yes
32Romania
711EUCTR2009-014688-37-FR
(EUCTR)
04/12/200909/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3France;Poland;Spain;Germany
712EUCTR2009-012419-16-DE
(EUCTR)
03/12/200920/10/2009Influence 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-PDInfluence 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
713EUCTR2009-013886-24-CZ
(EUCTR)
26/11/200918/11/2009A 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
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Germany;Czech Republic;Sweden
714EUCTR2008-005492-94-FR
(EUCTR)
25/11/200901/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
715EUCTR2008-005492-94-ES
(EUCTR)
23/11/200918/09/2009Open-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 ParkinsonOpen-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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
716EUCTR2009-013670-41-CZ
(EUCTR)
18/11/200907/09/2009A 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 DiseaseA 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 AGNULLNot RecruitingFemale: yes
Male: yes
126Czech Republic;France
717NCT00660673
(ClinicalTrials.gov)
November 13, 200915/4/2008Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PDOpen-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 StudiesAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pumpAbbVieIQVIA, formerly QuintilesCompleted30 Years99 YearsAll262Phase 3United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic
718EUCTR2009-013004-31-IT
(EUCTR)
02/11/200902/11/2009Early 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 diseaseEarly 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 PARMANULLNot RecruitingFemale: yes
Male: yes
Italy
719NCT01532128
(ClinicalTrials.gov)
November 200923/1/2012Effect of BIA 9-1067 on Rasagiline PharmacokineticsEffect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: rasagiline;Drug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll24Phase 1France
720NCT01519284
(ClinicalTrials.gov)
November 200923/1/2012Study of BIA 9-1067 to Investigate Its Effect on Levodopa PharmacokineticA 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 SubjectsParkinson DiseaseDrug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll82Phase 1Portugal
721NCT01052831
(ClinicalTrials.gov)
November 200915/1/2010Naltrexone for Impulse Control Disorders in Parkinson's DiseaseRandomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's DiseaseImpulse Control Disorder;Parkinson DiseaseDrug: Naltrexone;Drug: PlaceboUniversity of PennsylvaniaMichael J. Fox Foundation for Parkinson's ResearchCompleted18 Years85 YearsAll50Phase 4United States
722NCT01007630
(ClinicalTrials.gov)
November 20093/11/2009A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's PatientsA Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboThe Parkinson's InstituteTeva Neuroscience, Inc.Active, not recruitingN/A90 YearsBoth36Phase 4United States
723NCT01023282
(ClinicalTrials.gov)
November 20091/12/2009Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease PatientsRandomised, 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 MeasureParkinson's Disease;TolerabilityDrug: ACR325;Drug: PlaceboNeuroSearch A/SNULLCompleted30 Years75 YearsBoth22Phase 1Germany
724NCT01532141
(ClinicalTrials.gov)
November 200923/1/2012Effect of Rasagiline on BIA 9-1067 PharmacokineticsEffect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: RasagilineBial - Portela C S.A.NULLCompleted18 Years45 YearsAll25Phase 1France
725NCT01028209
(ClinicalTrials.gov)
November 20098/12/2009Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F] PBR06Institute for Neurodegenerative DisordersNULLTerminated18 YearsN/AAll12Phase 1United States
726EUCTR2008-005492-94-HU
(EUCTR)
27/10/200922/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
727EUCTR2008-004146-88-PL
(EUCTR)
19/10/200931/08/2009A 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 27918A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
728EUCTR2008-005492-94-SK
(EUCTR)
14/10/200922/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
729EUCTR2009-011541-24-GB
(EUCTR)
09/10/200929/05/2009A 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 rasagilineAn 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 LtdNULLNot 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): yesPortugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands
730EUCTR2008-005492-94-AT
(EUCTR)
02/10/200903/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United 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
731EUCTR2008-005492-94-EE
(EUCTR)
01/10/200915/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United 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
732EUCTR2006-005186-18-NL
(EUCTR)
25/09/200929/05/2008Open-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-FluctuationsOpen-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.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
733EUCTR2009-011541-24-DE
(EUCTR)
22/09/200927/07/2009An 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-UpAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom
734EUCTR2009-011541-24-PT
(EUCTR)
09/09/200929/07/2009An 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-UpAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
735NCT00986414
(ClinicalTrials.gov)
September 200929/9/2009Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease13-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 DiseaseParkinson Disease;DyskinesiasDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll260Phase 2Australia;Canada;Finland;France;Germany;Italy;Japan;Spain
736EUCTR2009-011541-24-ES
(EUCTR)
27/08/200926/06/2009 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 LtdNULLNot 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): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
737EUCTR2008-004146-88-BG
(EUCTR)
13/08/200913/07/2009A 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
738EUCTR2008-008712-98-DE
(EUCTR)
07/08/200913/07/200913-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 disease13-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 AGNULLNot RecruitingFemale: yes
Male: yes
198France;Finland;Spain;Germany;Italy
739EUCTR2008-004146-88-PT
(EUCTR)
31/07/200914/04/2009A 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 27918A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
740EUCTR2009-011541-24-FR
(EUCTR)
17/07/200919/06/2009An 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-UpAn 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 LtdNULLNot 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): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
741EUCTR2009-011541-24-HU
(EUCTR)
10/07/200905/06/2009An 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-UpAn 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 LtdNULLNot 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): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
742NCT00909545
(ClinicalTrials.gov)
July 200926/5/2009Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson DiseaseA 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 DiseaseParkinson DiseaseDrug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: PlaceboNorthwestern UniversityMichael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study GroupCompleted30 YearsN/AAll99Phase 2United States;Canada
743EUCTR2009-011541-24-IT
(EUCTR)
24/06/200926/06/2009An 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 -UpAn 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Germany;Netherlands;United Kingdom;Italy
744EUCTR2008-004146-88-ES
(EUCTR)
16/06/200916/04/2009A 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 27918A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
745EUCTR2008-001966-10-EE
(EUCTR)
16/06/200913/05/2009A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
746EUCTR2008-008712-98-FR
(EUCTR)
10/06/200928/04/200913-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 disease13-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 AGNULLNot RecruitingFemale: yes
Male: yes
234France;Finland;Spain;Germany;Italy
747EUCTR2008-004146-88-CZ
(EUCTR)
08/06/200907/04/2009An 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 agonistA 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
748EUCTR2009-010193-38-LV
(EUCTR)
04/06/200924/08/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
749EUCTR2009-010193-38-LT
(EUCTR)
02/06/200926/03/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
750EUCTR2008-001966-10-AT
(EUCTR)
27/05/200908/04/2009A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
751EUCTR2008-004146-88-IT
(EUCTR)
26/05/200927/04/2009A 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 SANULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
752EUCTR2008-001966-10-SK
(EUCTR)
25/05/200928/05/2009A 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 27919A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Estonia;Hungary;Slovakia;Austria;United Kingdom
753EUCTR2008-004146-88-SK
(EUCTR)
25/05/200928/05/2009A 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 27918A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
754EUCTR2008-004146-88-FI
(EUCTR)
19/05/200906/04/2009An 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 agonistA 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
755EUCTR2008-008712-98-FI
(EUCTR)
18/05/200908/04/200913-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 disease13-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 AGNULLNot RecruitingFemale: yes
Male: yes
198Finland;Germany;France;Spain;Italy
756EUCTR2008-008712-98-IT
(EUCTR)
14/05/200905/05/200913-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 - ND13-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 FARMANULLNot RecruitingFemale: yes
Male: yes
234Finland;Germany;France;Spain;Italy
757EUCTR2008-001966-10-GB
(EUCTR)
12/05/200927/04/2009A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
758EUCTR2008-000400-81-DE
(EUCTR)
11/05/200929/01/2009A 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 DyskinesiaA 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.NULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
759EUCTR2006-000578-53-DE
(EUCTR)
08/05/200930/10/2008Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsOpen-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 LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
70United States;Germany;New Zealand
760EUCTR2009-010193-38-EE
(EUCTR)
07/05/200915/04/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA 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.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
761EUCTR2008-001966-10-HU
(EUCTR)
04/05/200906/04/2009A 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 - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
762EUCTR2007-002963-28-BG
(EUCTR)
03/05/200921/05/2009A 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 SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3South Africa;Germany;Bulgaria;Peru;Croatia;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;India;Italy;Colombia;Chile;Spain;Finland;United States;Portugal
763NCT00767546
(ClinicalTrials.gov)
May 20095/10/2008Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian PatientsBotulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian PatientsParkinson Disease;Parkinsonism;Seborrheic DermatitisDrug: Botulinum toxinRabin Medical CenterNULLNot yet recruiting18 YearsN/ABoth40Phase 1NULL
764EUCTR2008-002769-30-IT
(EUCTR)
30/04/200922/04/2009A 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 pharmacokineticsA 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 SANULLNot RecruitingFemale: yes
Male: yes
Italy
765EUCTR2008-005492-94-IT
(EUCTR)
30/04/200915/04/2009OPEN 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 SANULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
766EUCTR2007-004234-16-AT
(EUCTR)
14/04/200910/03/2008Long-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 KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
767EUCTR2007-001095-36-SK
(EUCTR)
09/04/200909/04/2008The 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 StudyThe 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
625Phase 3Hungary;Slovakia
768EUCTR2008-005085-30-DE
(EUCTR)
06/04/200904/03/2009Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with RasagilineEinfluss 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 DresdenNULLNot RecruitingFemale: yes
Male: yes
Germany
769EUCTR2008-000400-81-PT
(EUCTR)
03/04/200927/01/2009A 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 DyskinesiaA 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 BVNULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
770EUCTR2007-004235-37-AT
(EUCTR)
02/04/200910/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 KGNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
771EUCTR2007-002963-28-PL
(EUCTR)
02/04/200927/02/2009A 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 SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
772EUCTR2007-002964-90-AT
(EUCTR)
02/04/200913/02/2008A 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 SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United 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
773JPRN-UMIN000001841
2009/04/0102/04/2009A 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 Parkinson diseaseVitamin D3
placebo
Jikei University School of MedicineNULLComplete: follow-up complete45years-old85years-oldMale and Female120Not selectedJapan
774EUCTR2008-000400-81-IT
(EUCTR)
31/03/200917/04/2009A 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 - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
775EUCTR2007-003035-22-AT
(EUCTR)
30/03/200926/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
560Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
776EUCTR2008-004447-11-GB
(EUCTR)
27/03/200907/01/2009A 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 DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Germany;United Kingdom;Italy
777EUCTR2007-002963-28-PT
(EUCTR)
26/03/200907/01/2009A 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 agonistA 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-GenevaNULLNot RecruitingFemale: yes
Male: yes
1036Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
778NCT00888004
(ClinicalTrials.gov)
March 200923/4/2009Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease PatientsA 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 DyskinesiasParkinson's Disease;L-dopa Induced DyskinesiaDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years85 YearsBoth28Phase 2Germany
779EUCTR2006-005186-18-CZ
(EUCTR)
09/02/200921/11/2007Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
320United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand
780EUCTR2008-006045-10-FR
(EUCTR)
06/02/200924/03/2009Effet 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 TEPEffet 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: ApokinonCHU de RennesNULLNot 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): noFrance
781NCT00806468
(ClinicalTrials.gov)
February 20099/12/2008Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson DiseaseA Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson DiseaseParkinson DiseaseDrug: DesmotabsJohannes Gutenberg University MainzNULLTerminated18 Years85 YearsMale1Phase 4Germany
782EUCTR2007-007853-30-SE
(EUCTR)
28/01/200921/12/2007A 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 ABNULLNot RecruitingFemale: yes
Male: yes
Sweden
783EUCTR2009-015833-66-IT
(EUCTR)
20/01/200918/04/2012Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate releaseRopinirole 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 - PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
784EUCTR2007-002963-28-CZ
(EUCTR)
19/01/200930/10/2007A 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 SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
785EUCTR2007-003035-22-PT
(EUCTR)
09/01/200901/07/2008A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA 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 IncNULLNot 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): noPortugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
786EUCTR2007-003035-22-IT
(EUCTR)
07/01/200923/07/2008A 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.NULLNot RecruitingFemale: yes
Male: yes
486Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden
787EUCTR2008-004906-15-FR
(EUCTR)
05/01/200916/03/2009EVALUATION 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 ParkinsonEVALUATION 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: DATSCANCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
788EUCTR2004-000148-26-AT
(EUCTR)
31/12/200826/11/2008A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden
789EUCTR2008-003966-25-DE
(EUCTR)
23/12/200804/11/2008Double-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. - DEPOPADouble-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 NeurologieNULLNot RecruitingFemale: no
Male: yes
20Germany
790EUCTR2006-005186-18-GB
(EUCTR)
19/11/200827/06/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn 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.NULLNot 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): noPortugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
791EUCTR2007-006721-27-GB
(EUCTR)
11/11/200825/02/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
792EUCTR2007-003051-36-BE
(EUCTR)
06/11/200821/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280Austria;Sweden;Portugal;Spain;Belgium
793EUCTR2007-003035-22-GB
(EUCTR)
05/11/200820/12/2007 A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA 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.NULLNot 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): noUnited States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
794NCT00629161
(ClinicalTrials.gov)
November 200825/2/2008Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson DiseaseParkinson DiseaseDrug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant);Drug: placeboFudan UniversityNULLRecruiting50 YearsN/ABoth144Phase 2/Phase 3China
795NCT00869791
(ClinicalTrials.gov)
November 200824/3/2009A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaA Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll27Phase 2United States
796EUCTR2007-006721-27-AT
(EUCTR)
20/10/200815/09/2008A 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.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Austria;United Kingdom
797EUCTR2007-004890-24-PT
(EUCTR)
07/10/200825/06/2008A 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 - FOEHNA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Portugal;France
798EUCTR2008-003869-72-PT
(EUCTR)
03/10/200825/06/2008A 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 INHIBITORA 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.NULLNot RecruitingFemale: yes
Male: yes
12Portugal
799EUCTR2007-000350-31-IT
(EUCTR)
02/10/200811/02/2008A 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) - NDA 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 FARMANULLNot RecruitingFemale: yes
Male: yes
550France;Spain;Italy
800EUCTR2007-004235-37-IT
(EUCTR)
02/10/200828/11/2007Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - NDLong-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.NULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
801EUCTR2006-005186-18-DE
(EUCTR)
30/09/200813/11/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn 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.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
802EUCTR2008-003225-16-FI
(EUCTR)
10/09/200830/05/2008Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilaillaAivostimulaattorin 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: DuodopaOrganisation name was not enteredNULLNot RecruitingFemale: yes
Male: yes
Finland
803EUCTR2007-003051-36-AT
(EUCTR)
10/09/200829/04/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
804EUCTR2007-003051-36-PT
(EUCTR)
05/09/200827/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
805EUCTR2007-003035-22-BE
(EUCTR)
02/09/200821/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
806NCT00758849
(ClinicalTrials.gov)
September 200824/9/2008Fipamezole in Neurogenic Orthostatic HypotensionA 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 DiseaseSymptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System AtrophyDrug: Placebo;Drug: FipamezoleJuvantia Pharma LtdSanthera PharmaceuticalsNot yet recruiting30 Years80 YearsBoth24Phase 2France;Portugal
807EUCTR2007-004235-37-GB
(EUCTR)
19/08/200826/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 IngelheimNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
808EUCTR2004-005234-39-DE
(EUCTR)
11/08/200802/12/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden
809NCT00601978
(ClinicalTrials.gov)
August 200811/1/2008Carbidopa/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 OffA 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 OffParkinson's DiseaseDrug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/EntacaponeNovartis PharmaceuticalsNULLWithdrawn45 Years75 YearsBoth0Phase 4United States
810EUCTR2004-000148-26-HU
(EUCTR)
26/07/200819/07/2004A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Finland;Hungary;Czech Republic;Spain;Italy;Sweden
811EUCTR2007-003051-36-ES
(EUCTR)
01/07/200805/05/2008Ensayo 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 DiseaseEnsayo 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 IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
812EUCTR2007-003051-36-SE
(EUCTR)
30/06/200816/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
813EUCTR2007-002963-28-IT
(EUCTR)
30/06/200804/01/2008A 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 SANULLNot RecruitingFemale: yes
Male: yes
666Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
814EUCTR2007-003134-42-DE
(EUCTR)
19/06/200820/02/2008A 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 AGNULLNot RecruitingFemale: yes
Male: yes
20Germany
815EUCTR2007-003035-22-SE
(EUCTR)
11/06/200816/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
816EUCTR2007-002964-90-HU
(EUCTR)
03/06/200815/11/2007A 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 levodopaA 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.-GenevaNULLNot RecruitingFemale: yes
Male: yes
1121Phase 3France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
817EUCTR2007-004235-37-PL
(EUCTR)
29/05/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden
818EUCTR2007-004009-93-IT
(EUCTR)
20/05/200814/07/2008Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopramPrevalence 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 ITALIANULLNot RecruitingFemale: yes
Male: yes
Italy
819EUCTR2006-006752-35-DE
(EUCTR)
06/05/200823/03/2007RECOVER: 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 - RECOVERRECOVER: 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
820NCT01238926
(ClinicalTrials.gov)
May 20089/11/2010Vitamin B6, B12, Folic Acid and Exercise in Parkinson's DiseaseEffects of Vitamin Supplementation and Strength Training in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: PD vitamin supplementation;Other: PD exercise intervention;Other: PD vitamin + exerciseNew York Institute of TechnologyStony Brook UniversityActive, not recruiting50 Years80 YearsBoth40N/AUnited States
821EUCTR2007-004235-37-SE
(EUCTR)
23/04/200825/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 ABNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
822EUCTR2007-004234-16-FI
(EUCTR)
16/04/200812/02/2008Long-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 KyNULLNot RecruitingFemale: yes
Male: yes
520Hungary;Finland;Czech Republic;Netherlands;France;Austria
823EUCTR2007-002906-23-BG
(EUCTR)
16/04/200807/07/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280United Kingdom;France;Bulgaria
824EUCTR2007-001096-10-SK
(EUCTR)
11/04/200809/04/2008An 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 StudyAn 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Slovakia
825NCT00753636
(ClinicalTrials.gov)
April 200813/9/2008Parkinson's Disease Isradipine Safety StudyPhase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage IIParkinson's DiseaseDrug: Dynacirc CR (Isradipine)Northwestern UniversityNorthwestern Memorial HospitalCompleted30 Years75 YearsAll31Phase 2United States
826NCT00651183
(ClinicalTrials.gov)
April 200831/3/2008Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentNon-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentParkinson DiseaseDrug: Pramipexole immediate releaseBoehringer IngelheimNULLCompleted18 YearsN/AAll286Austria
827EUCTR2007-005033-11-DE
(EUCTR)
27/03/200804/01/2008A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s DiseaseA Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease Patients with Parkinson's DiseaseProduct 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, IncNULLNot RecruitingFemale: yes
Male: yes
Germany
828EUCTR2007-001096-10-HU
(EUCTR)
27/03/200815/02/2008An 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 StudyAn 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Hungary
829EUCTR2007-001095-36-HU
(EUCTR)
27/03/200806/02/2008The 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 StudyThe 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
625Hungary
830EUCTR2007-002964-90-GB
(EUCTR)
20/03/200814/01/2009 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 - GenevaNULLNot 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): noFrance;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
831EUCTR2007-004235-37-HU
(EUCTR)
17/03/200817/01/2008Long-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 mbHNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
832EUCTR2007-004234-16-HU
(EUCTR)
17/03/200817/01/2008Long-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 mbHNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
833EUCTR2006-005186-18-PT
(EUCTR)
07/03/200814/11/2007An 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.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
834NCT00727727
(ClinicalTrials.gov)
March 200831/7/2008SEDPARK2: 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 DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth750N/AGermany
835NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/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 OffAn 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 OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
836EUCTR2007-003035-22-FR
(EUCTR)
29/02/200815/02/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA 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 IncNULLNot 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): noPortugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
837EUCTR2007-002964-90-DE
(EUCTR)
28/02/200817/12/2008A 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 levodopaA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
484Phase 3France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom
838EUCTR2007-002964-90-EE
(EUCTR)
13/02/200802/01/2008A 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 SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United 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
839EUCTR2007-000350-31-ES
(EUCTR)
13/02/200821/12/2007Estudio 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.ANULLNot RecruitingFemale: yes
Male: yes
550Phase 3France;Spain;Italy
840EUCTR2006-005186-18-IT
(EUCTR)
08/02/200814/11/2007Open-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.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
841EUCTR2007-002195-34-FR
(EUCTR)
04/02/200807/12/2007Evaluation 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 MEDICAMENTNULLNot 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): noFrance
842NCT00624741
(ClinicalTrials.gov)
February 200815/2/2008Compassionate Use Study of Pergolide in Patients With Parkinson's DiseaseCompassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's DiseaseParkinson DiseaseDrug: PergolideValeant Pharmaceuticals International, Inc.NULLNo longer availableN/AN/ABothN/ANULL
843EUCTR2007-002467-27-GB
(EUCTR)
24/01/200826/11/2007Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramateAntidyskinetic 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 TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
844EUCTR2007-004235-37-ES
(EUCTR)
24/01/200808/03/2010Long-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 PDLong-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.NULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden
845EUCTR2006-005186-18-ES
(EUCTR)
23/01/200829/11/2007Open-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 severasOpen-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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
846EUCTR2007-000350-31-FR
(EUCTR)
22/01/200825/10/2007A 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 AGNULLNot RecruitingFemale: yes
Male: yes
550France;Spain;Italy
847EUCTR2006-006752-35-IT
(EUCTR)
21/01/200824/04/2007PHASE 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 - RECOVERPHASE 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
336Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
848EUCTR2007-004234-16-CZ
(EUCTR)
21/01/200818/12/2007Long-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 KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
849EUCTR2007-004235-37-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden
850EUCTR2007-002963-28-ES
(EUCTR)
17/01/200816/11/2007A 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 agonistA 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.NULLNot RecruitingFemale: yes
Male: yes
1036Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
851EUCTR2007-004235-37-SK
(EUCTR)
14/01/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-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 KGNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
852EUCTR2007-004234-16-SK
(EUCTR)
14/01/200818/04/2008Long-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 KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
853EUCTR2007-004234-16-FR
(EUCTR)
11/01/200819/11/2007Long-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 INGELHEIMNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
854NCT00623103
(ClinicalTrials.gov)
January 200814/2/2008Long-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 DementiaDrug: Rivastigmine capsule;Drug: Rivastigmine transdermal patchNovartisNULLCompleted50 Years85 YearsAll583Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom
855NCT00725478
(ClinicalTrials.gov)
January 200828/7/2008SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's DiseaseStabilization 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 DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth250N/ANULL
856NCT01628965
(ClinicalTrials.gov)
January 200825/6/2012A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease PatientsAn 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-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll143Phase 2/Phase 3Japan
857NCT00608231
(ClinicalTrials.gov)
January 20087/1/2008Dexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationDexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationParkinson's Disease;Essential Tremor;DystoniaDrug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal SalineVanderbilt UniversityNULLWithdrawn18 YearsN/ABoth0Phase 2/Phase 3United States
858EUCTR2006-003732-30-IT
(EUCTR)
31/12/200713/02/2008Transdermal 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 ITransdermal 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 GMBHNULLNot RecruitingFemale: yes
Male: yes
350Germany;Italy;Poland
859EUCTR2007-000801-30-HU
(EUCTR)
20/12/200715/11/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
860EUCTR2007-004654-81-GB
(EUCTR)
20/12/200716/10/2007A 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 patientsA 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.NULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
861EUCTR2006-006907-35-IT
(EUCTR)
19/12/200720/04/2007A 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 RECOVERA 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
862EUCTR2004-000185-12-GB
(EUCTR)
13/12/200711/02/2005A 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-PDA 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, FinlandNULLNot 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): noFinland;Austria;Italy;United Kingdom;Sweden
863EUCTR2007-002963-28-FI
(EUCTR)
12/12/200718/10/2007A 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 SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany
864EUCTR2007-002964-90-SK
(EUCTR)
06/12/200716/04/2008A 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 levodopaA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
540Phase 3France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
865EUCTR2007-002963-28-SK
(EUCTR)
06/12/200716/04/2008A 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 agonistA 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. - GenevaNULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
866EUCTR2007-002964-90-FI
(EUCTR)
04/12/200718/10/2007A 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 levodopaA 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.NULLNot RecruitingFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
867EUCTR2007-004985-41-SE
(EUCTR)
29/11/200710/10/2007Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia studyDifferent 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, neurologyNULLNot RecruitingFemale: yes
Male: yes
Sweden
868EUCTR2007-000801-30-ES
(EUCTR)
29/11/200712/09/2007A 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 motorasA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Phase 3France;Hungary;Estonia;Czech Republic;Poland;Spain;Lithuania;Latvia;Italy
869NCT00537017
(ClinicalTrials.gov)
November 23, 200727/9/2007Follow 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 DiseasesDrug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll140Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
870EUCTR2006-005186-18-FI
(EUCTR)
16/11/200704/10/2007Open-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-FluctuationsOpen-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.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
871EUCTR2007-002906-23-GB
(EUCTR)
14/11/200715/08/2007A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA 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 IncNULLNot RecruitingFemale: yes
Male: yes
280United Kingdom;Bulgaria;France
872EUCTR2007-002496-14-FI
(EUCTR)
05/11/200714/09/2007Effects 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
Finland
873NCT00605683
(ClinicalTrials.gov)
November 200719/12/2007MOTION, Safinamide in Early IPD, as add-on to Dopamine AgonistA 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 AgonistIdiopathic Parkinson's DiseaseDrug: Safinamide (as add-on therapy)NewronNULLCompleted30 Years80 YearsBoth679Phase 3United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel
874NCT00584090
(ClinicalTrials.gov)
November 200721/12/2007Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's DiseaseUrinary Incontinence;Parkinson's DiseaseDrug: Solifenacin Succinate (VESIcare);Drug: PlaceboUniversity of South FloridaNULLWithdrawn30 Years80 YearsBoth0Phase 4United States
875NCT00558337
(ClinicalTrials.gov)
November 200712/11/2007Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's DiseaseAn Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease PatientsParkinson's DiseaseDrug: levodopa-carbidopaOsmotica Pharmaceutical Corp.NULLCompleted30 Years80 YearsBoth78Phase 2Argentina
876NCT00632762
(ClinicalTrials.gov)
November 200720/2/2008Long-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 DiseaseDrug: mantadixUniversity Hospital, ToulouseNULLCompleted30 Years80 YearsBoth80Phase 4France
877NCT00560508
(ClinicalTrials.gov)
November 200716/11/2007A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment PeriodA 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 ERParkinson DiseaseDrug: Pramipexole Immediate Release;Drug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted1 YearN/AAll112Phase 2/Phase 3Japan
878NCT00610103
(ClinicalTrials.gov)
November 200722/1/2008Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa TherapyA Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: apomorphine hydrochlorideKyowa Kirin Co., Ltd.NULLCompleted20 YearsN/AAll16Phase 2Japan
879NCT01301651
(ClinicalTrials.gov)
November 200718/2/2011Effects of Virtual Reality Training in Patients With Parkinson's DiseaseEffects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's DiseaseParkinson's DiseaseBehavioral: balance trainingNational Taiwan University HospitalNational Science Council, TaiwanCompleted50 Years80 YearsBoth42Phase 1Taiwan
880EUCTR2007-004234-16-NL
(EUCTR)
29/10/200717/10/2007Long-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 bvNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
881EUCTR2007-002906-23-FR
(EUCTR)
25/10/200721/08/2007A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA 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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280United Kingdom;Bulgaria;France
882EUCTR2007-000801-30-FR
(EUCTR)
22/10/200723/07/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Phase 3France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
883EUCTR2007-003353-90-FR
(EUCTR)
17/10/200727/08/2007A 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 INGELHEIMNULLNot RecruitingFemale: yes
Male: yes
145Phase 3France;Germany;Netherlands
884EUCTR2006-006907-35-GB
(EUCTR)
09/10/200726/04/2007Long-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 RECOVERLong-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 GroupNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
885EUCTR2005-005791-32-SE
(EUCTR)
04/10/200730/07/2007Chemical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom;Sweden
886EUCTR2007-002900-16-DE
(EUCTR)
01/10/200721/08/2007A 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-dopaA 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 AGNULLNot RecruitingFemale: yes
Male: yes
34Germany
887NCT00547911
(ClinicalTrials.gov)
October 200719/10/2007Augmenting Effects of L-DOPS With Carbidopa and EntacaponeL-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and EntacaponeParkinson Disease;Multiple System Atrophy;Autonomic Nervous System DiseasesDrug: Droxidopa;Drug: Carbidopa;Drug: EntacaponeNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 YearsN/AAll14Phase 1/Phase 2United States
888NCT00582673
(ClinicalTrials.gov)
October 200721/12/2007Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopaA 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-dopaParkinson's DiseaseDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years85 YearsBoth31Phase 2Germany
889EUCTR2006-002937-20-HU
(EUCTR)
20/09/200717/05/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
890EUCTR2007-002899-34-GB
(EUCTR)
18/09/200726/06/2007Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's DiseasePilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease Cognitive impairment in Parkinson's DiseaseProduct Name: Sage leafNewcastle Upon tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
891EUCTR2007-002874-75-IT
(EUCTR)
10/09/200714/01/2008Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005Safety 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: MelperonOVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
892EUCTR2007-000801-30-LT
(EUCTR)
07/09/200705/07/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
893EUCTR2007-003353-90-DE
(EUCTR)
05/09/200708/08/2007A 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. KGNULLNot RecruitingFemale: yes
Male: yes
132Germany;Netherlands;France
894NCT00537485
(ClinicalTrials.gov)
September 200727/9/2007A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease PatientsA Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopaEarly Parkinson's DiseaseDrug: SPM 962;Drug: placeboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll180Phase 2/Phase 3Japan
895NCT00524914
(ClinicalTrials.gov)
September 20074/9/2007Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging StudyApomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.Parkinson's DiseaseDrug: apomorphine;Drug: placeboUniversity Hospital, ToulouseNULLCompleted30 Years70 YearsBoth16N/AFrance
896EUCTR2007-000801-30-PL
(EUCTR)
29/08/200717/07/2007A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Phase 3Spain;Poland;Lithuania;Latvia;Italy;France;Hungary;Estonia;Czech Republic
897EUCTR2007-000801-30-EE
(EUCTR)
22/08/200717/07/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
898EUCTR2006-000859-18-DE
(EUCTR)
13/08/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania
899EUCTR2007-000074-23-HU
(EUCTR)
10/08/200701/06/2007A 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 mbHNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
900EUCTR2007-000801-30-CZ
(EUCTR)
01/08/200715/06/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
901EUCTR2007-000801-30-LV
(EUCTR)
27/07/200705/07/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
902EUCTR2006-006752-35-GB
(EUCTR)
23/07/200713/01/2009 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 GroupNULLNot 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): noHungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
903EUCTR2007-000801-30-IT
(EUCTR)
17/07/200713/11/2007A 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 - NDA 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: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
726Phase 3France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
904NCT00519532
(ClinicalTrials.gov)
July 200721/8/2007Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA 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 DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLTerminated18 YearsN/AAll84Phase 3United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria
905EUCTR2006-006752-35-HU
(EUCTR)
22/06/200712/04/2007RECOVER: 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 - RecoverRECOVER: 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
906EUCTR2007-000074-23-CZ
(EUCTR)
18/06/200731/05/2007A 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 KGNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden
907EUCTR2007-000073-39-CZ
(EUCTR)
18/06/200718/04/2007A 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 KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
908EUCTR2006-000678-57-CZ
(EUCTR)
18/06/200702/08/2006A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
909EUCTR2007-000074-23-SK
(EUCTR)
14/06/200709/04/2008A 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 mbHNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
910EUCTR2007-000073-39-HU
(EUCTR)
14/06/200731/05/2007A 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 mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Finland;Hungary;Czech Republic;Austria
911EUCTR2007-000073-39-SK
(EUCTR)
14/06/200709/04/2008A 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 mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Finland;Austria;Germany
912EUCTR2006-005438-19-DE
(EUCTR)
12/06/200728/03/2007An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOSAn 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
30Germany
913EUCTR2006-005861-21-IT
(EUCTR)
11/06/200705/01/2007A 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Italy
914EUCTR2006-000858-45-SE
(EUCTR)
05/06/200704/04/2007An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
915JPRN-UMIN000000780
2007/06/0101/08/2007A 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 Parkinson's diseaseAn 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 disordersMusashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University HospitalComplete: follow-up complete20years-old75years-oldMale and Female60Not applicableJapan
916EUCTR2007-000074-23-AT
(EUCTR)
30/05/200705/06/2007A 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. KGNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
917EUCTR2007-000073-39-AT
(EUCTR)
30/05/200705/06/2007A 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 mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
918EUCTR2007-000073-39-DE
(EUCTR)
29/05/200726/02/2007A 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. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Czech Republic;Finland;Austria;Germany
919EUCTR2007-000074-23-ES
(EUCTR)
29/05/200702/03/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
920EUCTR2006-006907-35-ES
(EUCTR)
27/05/200727/03/2007EXTENSIÓN 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 RECOVEREXTENSIÓN 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
921EUCTR2006-006752-35-ES
(EUCTR)
27/05/200727/03/2007RECOVER: 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) - RecoverRECOVER: 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
922EUCTR2007-000074-23-IT
(EUCTR)
17/05/200706/04/2007A 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 . - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
645Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
923EUCTR2006-006907-35-HU
(EUCTR)
17/05/200712/04/2007Long-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 RECOVERLong-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Finland;Hungary;United Kingdom;Germany;Spain;Italy;Austria
924EUCTR2007-000074-23-GB
(EUCTR)
11/05/200729/03/2007A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
925EUCTR2006-006752-35-FI
(EUCTR)
09/05/200721/03/2007RECOVER: 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 - RecoverRECOVER: 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
926EUCTR2006-006907-35-FI
(EUCTR)
09/05/200721/03/2007Long-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 RECOVERLong-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
927EUCTR2007-000074-23-SE
(EUCTR)
02/05/200702/04/2007A 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 ABNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
928NCT00474058
(ClinicalTrials.gov)
May 200714/5/2007Randomized 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 DiseaseParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll287Phase 3United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom
929EUCTR2006-002339-26-PT
(EUCTR)
27/04/200707/03/2007A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
930EUCTR2006-002937-20-ES
(EUCTR)
27/04/200726/04/2007Estudio 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 MotorasEstudio 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
931EUCTR2006-000577-29-DE
(EUCTR)
27/04/200712/10/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s SubjectsA 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)NULLNot RecruitingFemale: yes
Male: yes
31United States;Germany
932EUCTR2007-000073-39-FI
(EUCTR)
25/04/200706/03/2007A 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 KyNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
933EUCTR2007-000307-15-IT
(EUCTR)
24/04/200723/08/2007Safety 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 INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
934EUCTR2006-002339-26-ES
(EUCTR)
19/04/200730/01/2007A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
935EUCTR2006-006907-35-AT
(EUCTR)
17/04/200721/05/2007Long-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 RECOVERLong-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
936EUCTR2006-006752-35-AT
(EUCTR)
17/04/200721/05/2007RECOVER: 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 - RecoverRECOVER: 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
937EUCTR2006-002339-26-DE
(EUCTR)
10/04/200722/12/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania
938NCT00623363
(ClinicalTrials.gov)
April 20072/1/2008Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's DiseaseParkinson's DiseaseDrug: piclozotan;Drug: 0.9% sodium chloride (normal saline)Asubio Pharmaceuticals, Inc.NULLCompleted40 Years85 YearsBoth27Phase 2United States;Guatemala;Romania
939EUCTR2006-006209-94-DE
(EUCTR)
15/03/200726/01/2007An 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
36Germany
940EUCTR2006-002937-20-FR
(EUCTR)
12/03/200712/02/2007A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Phase 3France;Hungary;Czech Republic;Estonia;Spain;Lithuania;Latvia;Italy
941EUCTR2006-005714-12-IT
(EUCTR)
27/02/200703/08/2007A 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-E044-213A 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 UKNULLNot RecruitingFemale: yes
Male: yes
24Italy
942EUCTR2005-002038-36-GR
(EUCTR)
27/02/200709/10/2006A 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 BodiesA 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/SNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;Greece;Spain;Austria;Germany;Italy;United Kingdom
943EUCTR2006-005183-91-LT
(EUCTR)
14/02/200720/12/2006An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian studyAn 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
220Latvia;Lithuania
944EUCTR2006-005182-20-LT
(EUCTR)
13/02/200720/12/2006A 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 studyA 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
280Latvia;Lithuania
945EUCTR2006-005183-91-LV
(EUCTR)
02/02/200711/01/2007An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan studyAn 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Latvia;Lithuania
946EUCTR2006-005182-20-LV
(EUCTR)
02/02/200728/12/2006A 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 studyA 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
280Latvia;Lithuania
947EUCTR2006-000859-18-NL
(EUCTR)
25/01/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
247Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
948EUCTR2006-002339-26-HU
(EUCTR)
24/01/200724/08/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
949EUCTR2006-000678-57-FR
(EUCTR)
09/01/200710/10/2006A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Phase 3Portugal;France;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom
950EUCTR2006-000859-18-PT
(EUCTR)
04/01/200718/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
951NCT00465452
(ClinicalTrials.gov)
January 200724/4/2007Impact of Switching to Continuous Release Dopamine AgonistsThe Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side EffectsParkinson DiseaseDrug: Continuous Release Dopamine AgonistsUniversity of Toledo Health Science CampusNULLCompleted55 YearsN/ABoth15Phase 3United States
952EUCTR2006-000678-57-PT
(EUCTR)
29/12/200610/08/2006A 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 studyA 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.NULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
953EUCTR2006-002339-26-GB
(EUCTR)
28/12/200616/10/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania
954EUCTR2005-002654-21-NO
(EUCTR)
28/12/200606/11/2006A 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. - DAPHNEA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
75Norway;Sweden
955EUCTR2006-000678-57-DE
(EUCTR)
22/12/200606/10/2006A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
376Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania
956EUCTR2006-005509-79-GB
(EUCTR)
21/12/200607/12/2006A 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 DiseaseA 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” periodsProduct Name: apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United Kingdom
957EUCTR2006-003490-27-GB
(EUCTR)
19/12/200629/09/2006A 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 LevodopaA 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 LTDNULLNot 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): noUnited Kingdom
958EUCTR2006-005860-14-IT
(EUCTR)
19/12/200617/03/2009A 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 - NDA 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Italy
959EUCTR2005-000314-12-DE
(EUCTR)
19/12/200625/01/2007Effect 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. - PARKOPIEffect 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 ServierNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Spain;Germany
960EUCTR2006-000858-45-FI
(EUCTR)
18/12/200626/06/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
961EUCTR2006-002339-26-IT
(EUCTR)
16/12/200605/06/2007Studio 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-G000-303Studio 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: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden
962EUCTR2006-002937-20-CZ
(EUCTR)
14/12/200624/10/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
963EUCTR2006-002937-20-EE
(EUCTR)
11/12/200619/10/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
964EUCTR2006-002937-20-LT
(EUCTR)
04/12/200602/11/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
965EUCTR2005-002038-36-FR
(EUCTR)
01/12/200624/08/2010A 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 BodiesA 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 BodiesTrade 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/SNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;Greece;Spain;Austria;Germany;Italy;United Kingdom
966NCT00853879
(ClinicalTrials.gov)
December 200626/2/2009An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseAn Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, PlaceboNorth Shore Long Island Jewish Health SystemNULLTerminated30 YearsN/ABoth150N/AUnited States
967EUCTR2005-002038-36-DE
(EUCTR)
29/11/200619/01/2007A 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 BodiesA 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 BodiesTrade 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/SNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;France;Spain;Italy;Greece;Austria
968EUCTR2006-001755-36-GB
(EUCTR)
20/11/200629/09/2006Efficacy 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 - SENSEEfficacy 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 PharmaNULLNot 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): yesGermany;United Kingdom;Sweden
969NCT00406029
(ClinicalTrials.gov)
November 20, 200630/11/2006Dyskinesia 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 DyskinesiasParkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain DiseasesDrug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll253Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States
970EUCTR2006-000678-57-GB
(EUCTR)
14/11/200630/05/2007A 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 studyA 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 pharmaceuticalsNULLNot 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): noFrance;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom
971EUCTR2006-004112-51-IT
(EUCTR)
14/11/200604/12/2006A 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 - NDA 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 LIMITEDNULLNot RecruitingFemale: yes
Male: yes
Italy
972EUCTR2006-001793-24-PT
(EUCTR)
07/11/200631/07/2006A 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 availableA 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, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
973EUCTR2006-000678-57-LT
(EUCTR)
07/11/200607/09/2006A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
974EUCTR2006-000859-18-LT
(EUCTR)
07/11/200607/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
975EUCTR2006-004582-33-GB
(EUCTR)
03/11/200623/01/2012A 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 DiseaseA 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 diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
48Phase 2United Kingdom
976EUCTR2006-000859-18-EE
(EUCTR)
03/11/200601/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
977EUCTR2006-000678-57-EE
(EUCTR)
03/11/200601/09/2006A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
978EUCTR2006-002339-26-CZ
(EUCTR)
01/11/200621/08/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
979EUCTR2006-002937-20-LV
(EUCTR)
01/11/200602/11/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
980NCT00397696
(ClinicalTrials.gov)
November 20067/11/2006Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons DiseaseEvaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease SubjectsParkinson DiseaseDrug: [123I] 5-IAInstitute for Neurodegenerative DisordersDepartment of DefenseCompleted21 YearsN/ABoth9Phase 2United States
981NCT00335166
(ClinicalTrials.gov)
November 20068/6/2006SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson DiseaseA 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 DiseaseDrug: Pardaprunox;Drug: pramipexole;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth330Phase 3United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom
982NCT00404170
(ClinicalTrials.gov)
November 200622/11/2006Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson DiseaseAssessing the Determinants of PD Progression - Long-term Dopamine Transporter Imaging in the PRECEPT CohortParkinson DiseaseDrug: B-CIT and SPECT imagingInstitute for Neurodegenerative DisordersUnited States Department of DefenseCompleted30 YearsN/AAll396Phase 2United States
983NCT00491998
(ClinicalTrials.gov)
November 200626/6/2007PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral TabletsRandomised, 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 TabletsParkinson's DiseaseDrug: V1512;Drug: V1512 and EntacaponeVernalis (R&D) LtdCita NeuroPharmaceuticals;INC ResearchCompleted30 YearsN/ABoth27Phase 1/Phase 2Italy
984NCT00360308
(ClinicalTrials.gov)
November 20062/8/2006Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA 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 FluctuationsParkinson's DiseaseDrug: Placebo;Drug: E2007Eisai LimitedNULLTerminated30 YearsN/AAll723Phase 3France
985NCT00387075
(ClinicalTrials.gov)
November 200610/10/2006A Study Evaluating Potential Screening Tools for Detecting Parkinson DiseaseParkinson Associated Risk Factor Study (PARS): Evaluating Potential Screening Tools for Parkinson DiseaseParkinson DiseaseProcedure: [123I]ß-CIT and SPECT imaging;Drug: [123I]ß-CITInstitute for Neurodegenerative DisordersUnited States Department of Defense;Molecular NeuroImagingActive, not recruiting50 YearsN/AAll3000Phase 2United States
986NCT00397228
(ClinicalTrials.gov)
November 20066/11/2006ALTROPANE® SPECT Imaging in Patients With Parkinson DiseaseOptimizing the Performance of ALTROPANE® SPECT Imaging in Patients With Parkinson DiseaseParkinson DiseaseDrug: ALTROPANE®Molecular NeuroImagingInstitute for Neurodegenerative DisordersCompleted30 YearsN/ABoth27Phase 2United States
987NCT00400634
(ClinicalTrials.gov)
November 200615/11/2006Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's DiseaseMulticenter, 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 DiseaseIdiopathic Parkinson's DiseaseDrug: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]);Procedure: Sham SurgeryCeregeneNULLCompleted35 Years75 YearsAll58Phase 2United States
988NCT00468078
(ClinicalTrials.gov)
November 200630/4/2007Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor PatientsThe 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 PatientsParkinson's DiseaseProcedure: PET/CT;Drug: F-18 FPCITAsan Medical CenterNULLCompleted40 YearsN/ABoth78Phase 3Korea, Republic of
989NCT00402233
(ClinicalTrials.gov)
November 200619/11/2006A 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) PatientsA 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 DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted31 YearsN/AAll312Phase 4United States
990EUCTR2005-002038-36-GB
(EUCTR)
31/10/200609/10/2006A 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 BodiesA 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/SNULLNot 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): yesFrance;Greece;Spain;Austria;Germany;Italy;United Kingdom
991EUCTR2006-002339-26-EE
(EUCTR)
20/10/200615/08/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania;Germany;Hungary;Portugal
992EUCTR2006-002339-26-SE
(EUCTR)
19/10/200622/09/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden
993EUCTR2006-002339-26-BE
(EUCTR)
16/10/200624/08/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
994EUCTR2006-000858-45-SK
(EUCTR)
11/10/200628/09/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Finland;Sweden
995EUCTR2006-002339-26-LT
(EUCTR)
05/10/200607/08/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
996NCT00391898
(ClinicalTrials.gov)
October 200624/10/2006Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-offA 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 LevodopaParkinson's DiseaseDrug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopaNovartisNULLCompleted30 Years80 YearsAll95Phase 4Spain
997NCT00399477
(ClinicalTrials.gov)
October 200610/11/2006A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's DiseaseOpen-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 DiseaseDrug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with RequipTeva Neuroscience, Inc.NULLCompleted30 YearsN/ABoth200Phase 4United States
998EUCTR2006-002339-26-AT
(EUCTR)
25/09/200618/10/2006A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
999EUCTR2005-002038-36-AT
(EUCTR)
22/09/200609/10/2006A 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 BodiesA 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 BodiesTrade 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/SNULLNot RecruitingFemale: yes
Male: yes
200Germany;United Kingdom;France;Spain;Italy;Greece;Austria
1000EUCTR2005-005146-39-IT
(EUCTR)
14/09/200606/12/2006A 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. - NDA 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 InstituteNULLNot RecruitingFemale: yes
Male: yes
160Italy
1001EUCTR2006-000678-57-IT
(EUCTR)
14/09/200626/06/2007A 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. - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
390Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1002EUCTR2006-000859-18-CZ
(EUCTR)
11/09/200602/08/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1003EUCTR2004-005234-39-LV
(EUCTR)
06/09/200629/09/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1004EUCTR2005-004949-34-SE
(EUCTR)
06/09/200627/03/2006A 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 StudyA 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 ABNULLNot RecruitingFemale: yes
Male: yes
500Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1005EUCTR2005-005423-34-HU
(EUCTR)
04/09/200605/07/2006A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1006NCT00462007
(ClinicalTrials.gov)
September 200617/4/2007Study to Evaluate Initiation of Stalevo in Early Wearing-offEfficacy 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 PatientsParkinson's DiseaseDrug: StalevoOrion Corporation, Orion PharmaNULLCompleted35 YearsN/ABoth115Phase 4Germany;Sweden;United Kingdom
1007EUCTR2005-006033-32-SE
(EUCTR)
15/08/200622/06/2006A 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 studyA 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 StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
1008EUCTR2006-001755-36-SE
(EUCTR)
09/08/200630/06/2006Efficacy 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 - SENSEEfficacy 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
1009EUCTR2005-004314-33-PT
(EUCTR)
09/08/200610/05/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1010EUCTR2005-004949-34-DE
(EUCTR)
04/08/200630/03/2006A 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 StudyA 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. KGNULLNot RecruitingFemale: yes
Male: yes
500Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1011EUCTR2006-000678-57-NL
(EUCTR)
03/08/200604/04/2007A 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 studyA 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 pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1012EUCTR2006-001793-24-AT
(EUCTR)
31/07/200624/07/2006A 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 availableA 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, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
1013EUCTR2006-003717-41-IT
(EUCTR)
13/07/200612/07/2007EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - NDEVALUATE 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 GEMELLINULLNot RecruitingFemale: yes
Male: yes
Italy
1014EUCTR2006-000680-28-ES
(EUCTR)
07/07/200622/05/2006Estudio 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' - DERBIEstudio 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.ANULLNot RecruitingFemale: yes
Male: yes
200Spain
1015EUCTR2006-000391-32-DE
(EUCTR)
04/07/200627/04/2006A 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 DiseaseA 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 DiseaseProduct Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Netherlands
1016NCT00354133
(ClinicalTrials.gov)
July 200619/7/2006Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's DiseaseThe 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 DiseaseDevice: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical TreatmentGerman Parkinson Study Group (GPS)University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS NetzwerkActive, not recruiting18 Years60 YearsAll251Phase 4France;Germany
1017EUCTR2006-000361-11-GB
(EUCTR)
23/06/200601/02/2006A 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 CorporationNULLNot 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): noUnited Kingdom
1018EUCTR2005-004314-33-DE
(EUCTR)
21/06/200601/12/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden
1019NCT00331149
(ClinicalTrials.gov)
June 20, 200626/5/2006A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sA 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 DiseaseDrug: Ropinirole prolonged release;Drug: ropinirole immediate releaseGlaxoSmithKlineNULLCompleted30 YearsN/AAll343Phase 3Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
1020EUCTR2005-004949-34-GB
(EUCTR)
19/06/200624/03/2006 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 LtdNULLNot 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): yesFinland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1021EUCTR2005-005423-34-DE
(EUCTR)
19/06/200602/03/2006A 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 diseaseProduct 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 LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1022EUCTR2005-006033-32-SK
(EUCTR)
13/06/200602/05/2006A 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 studyA 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 StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
1023EUCTR2006-000391-32-GB
(EUCTR)
06/06/200621/04/2006A 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 DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Netherlands;Germany;United Kingdom
1024EUCTR2005-004949-34-ES
(EUCTR)
29/05/200621/04/2006A 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 StudyA 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.NULLNot RecruitingFemale: yes
Male: yes
500Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1025EUCTR2005-005423-34-ES
(EUCTR)
19/05/200629/03/2006A 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 diseaseProduct 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
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1026EUCTR2005-004314-33-ES
(EUCTR)
19/05/200615/03/2006A 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 FluctuationsA 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 LimitedNULLNot 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): noPortugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1027EUCTR2005-004949-34-FI
(EUCTR)
17/05/200621/04/2006A 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 StudyA 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 IngelheimBoehringer Ingelheim Finland KyNot RecruitingFemale: yes
Male: yes
500Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1028EUCTR2005-005423-34-GB
(EUCTR)
11/05/200617/03/2006A 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 diseaseProduct 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 LtdNULLNot 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): noHungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1029EUCTR2004-005234-39-LT
(EUCTR)
09/05/200624/03/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania
1030EUCTR2005-005423-34-IT
(EUCTR)
08/05/200603/10/2006A 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. - NDA 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 DNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1031NCT00291733
(ClinicalTrials.gov)
May 200614/2/2006Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's DiseaseLevetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover TrialLevodopa Induced DyskinesiaDrug: Levetiracetam;Drug: Placebo1st Hospital of Social Security ServicesUCB PharmaActive, not recruiting30 Years80 YearsBoth50Phase 2Greece
1032EUCTR2005-005791-32-GB
(EUCTR)
24/04/200617/02/2006Chemical 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 LtdNULLNot 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
1033EUCTR2005-006033-32-FI
(EUCTR)
20/04/200606/03/2006A 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 studyA 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 StageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
1034EUCTR2005-005423-34-CZ
(EUCTR)
20/04/200603/03/2006A 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 diseaseProduct 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 LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy
1035EUCTR2005-004949-34-AT
(EUCTR)
18/04/200621/03/2006A 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 StudyA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
500Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden
1036EUCTR2005-001006-12-AT
(EUCTR)
02/04/200628/02/2006Double-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. - CALIPSODouble-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
1037NCT00461942
(ClinicalTrials.gov)
April 200617/4/2007Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsParkinson's DiseaseDrug: Green Tea Polyphenols (EGCG/ECG)Xuanwu Hospital, BeijingMinistry of Health, China;Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/ABoth480Phase 2China
1038NCT00646204
(ClinicalTrials.gov)
April 200628/12/2007Namenda (Memantine) for Non-Motor Symptoms in Parkinson's DiseaseA 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASEParkinson's DiseaseDrug: Memantine;Drug: placeboBaylor College of MedicineForest LaboratoriesCompleted18 Years80 YearsBoth40Phase 4United States
1039EUCTR2005-001032-72-PT
(EUCTR)
23/03/200611/11/2005A 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 StepA 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 diseaseTrade 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 AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
1040EUCTR2005-003788-22-SE
(EUCTR)
03/03/200619/12/2005A 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 symptomsTrade 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 ABNULLNot RecruitingFemale: yes
Male: yes
354Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
1041EUCTR2005-004314-33-HU
(EUCTR)
01/03/200620/12/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1042EUCTR2005-004314-33-GB
(EUCTR)
01/03/200629/11/2005A 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 FluctuationsA 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 LimitedNULLNot 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): noPortugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1043NCT00141518
(ClinicalTrials.gov)
March 200630/8/2005Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic ImpactA 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-/DyskinesiaAdvanced Idiopathic Parkinson's DiseaseDrug: 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)NULLCompleted18 Years99 YearsAll77Phase 4Norway;Sweden
1044EUCTR2005-003788-22-AT
(EUCTR)
22/02/200618/01/2006A 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 symptomsTrade 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
318Phase 1Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1045EUCTR2005-001032-72-CZ
(EUCTR)
16/02/200612/01/2006A 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 StepA 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 AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
1046EUCTR2005-003788-22-ES
(EUCTR)
09/02/200628/12/2005A 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 depresivosA 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 symptomsTrade 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.NULLNot RecruitingFemale: yes
Male: yes
318Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1047EUCTR2005-004314-33-SE
(EUCTR)
03/02/200613/12/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1048EUCTR2005-004290-19-GB
(EUCTR)
03/02/200609/01/2006A 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 diseaseA 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 GmbHNULLNot 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): noSpain;Austria;Germany;United Kingdom
1049EUCTR2005-004314-33-BE
(EUCTR)
02/02/200624/11/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1050EUCTR2005-004314-33-LT
(EUCTR)
01/02/200603/01/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania
1051EUCTR2005-004314-33-CZ
(EUCTR)
01/02/200611/01/2006A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1052EUCTR2005-003788-22-DE
(EUCTR)
01/02/200607/12/2005A 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 symptomsTrade 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. KGNULLNot RecruitingFemale: yes
Male: yes
354Phase 1Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1053NCT00630500
(ClinicalTrials.gov)
February 200627/2/2008Efficacy 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 BodiesDementia Associated With Parkinson's Disease;Dementia With Lewy BodiesDrug: Memantine;Drug: PlaceboHelse Stavanger HFKing's College London;Lund UniversityCompletedN/AN/ABoth75Phase 2Norway;Sweden;United Kingdom
1054EUCTR2005-004314-33-IT
(EUCTR)
31/01/200607/09/2007A 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. - NDA 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 UKNULLNot RecruitingFemale: yes
Male: yes
900Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1055EUCTR2005-004290-19-DE
(EUCTR)
25/01/200605/12/2005A 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 diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Spain
1056EUCTR2005-004314-33-EE
(EUCTR)
17/01/200624/11/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1057EUCTR2005-003788-22-FI
(EUCTR)
17/01/200607/12/2005A 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 symptomsTrade 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 KyNot RecruitingFemale: yes
Male: yes
318Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
1058EUCTR2005-003788-22-GB
(EUCTR)
06/01/200611/11/2005A 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 symptomsTrade 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
318Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1059NCT00272688
(ClinicalTrials.gov)
January 20066/1/2006Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefitContinuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic EvaluationParkinson DiseaseDrug: Levodopa (drug), intraduodenal administrationUniversity Hospital, AkershusSolvay PharmaceuticalsCompletedN/AN/ABoth10Phase 4Norway
1060EUCTR2005-005120-13-GB
(EUCTR)
21/12/200502/11/2005A 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 DiseaseA 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 diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
1061EUCTR2005-002432-10-MT
(EUCTR)
25/11/200510/10/2005A 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 diseaseA 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 stageProduct 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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
60Malta
1062EUCTR2005-001032-72-IT
(EUCTR)
25/11/200526/03/2007A 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 FARMANULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
1063EUCTR2005-000444-84-GB
(EUCTR)
23/11/200513/09/2005An 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-OAn 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
1064EUCTR2005-002010-38-DE
(EUCTR)
21/11/200510/02/2006Assessment 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 studyAssessment 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 DiseaseProduct Name: Trivastal
Product Code: S 90049
INN or Proposed INN: Piribedil
Institut de Recherches Internationales Servier (I.R.I.S.)NULLNot RecruitingFemale: yes
Male: yes
80Germany
1065EUCTR2005-001416-42-PT
(EUCTR)
07/11/200525/08/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA 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 LtDNULLNot RecruitingFemale: yes
Male: yes
1100Hungary;Portugal;Germany;United Kingdom;Spain;Italy
1066NCT00256204
(ClinicalTrials.gov)
November 200516/11/2005A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's DiseaseA Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease SubjectsParkinson's DiseaseDrug: Rasagiline Mesylate;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 Years80 YearsAll1174Phase 3Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States
1067NCT00250393
(ClinicalTrials.gov)
November 20054/11/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseasePlacebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin Company, LimitedNULLCompleted30 YearsN/ABoth64Phase 2Japan
1068NCT00253084
(ClinicalTrials.gov)
November 200511/11/2005Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 2United States
1069NCT00260793
(ClinicalTrials.gov)
November 20051/12/2005Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's DiseaseOpen Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's DiseaseParkinson's DiseaseDrug: Ropinirole HydrochlorideAgarwal, Pinky, M.D.Colorado Neurology;GlaxoSmithKlineRecruiting25 YearsN/ABoth20Phase 3United States
1070EUCTR2004-005234-39-IE
(EUCTR)
20/10/200516/08/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot 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): yesFinland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1071EUCTR2005-000314-12-ES
(EUCTR)
14/10/200508/09/2005Effect 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. - PARKOPIEffect 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 ServierNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Spain;Germany
1072NCT00199381
(ClinicalTrials.gov)
October 200512/9/2005An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001An 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 DiseaseDrug: IstradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLTerminated30 YearsN/AAll504Phase 3United States
1073EUCTR2005-001416-42-HU
(EUCTR)
27/09/200520/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA 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 LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1074EUCTR2004-005234-39-FI
(EUCTR)
22/09/200503/06/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1075EUCTR2005-001416-42-GB
(EUCTR)
15/09/200513/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA 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 LtDNULLNot 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): noPortugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1076EUCTR2005-000444-84-FI
(EUCTR)
08/09/200526/07/2005An 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-OAn 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;United Kingdom;Spain;Italy
1077EUCTR2005-001416-42-DE
(EUCTR)
01/09/200517/10/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA 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 LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;United Kingdom;Germany;Spain;Italy
1078EUCTR2005-001416-42-AT
(EUCTR)
24/08/200520/07/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA 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 LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1079EUCTR2005-002654-21-SE
(EUCTR)
08/08/200514/06/2005A 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. - DAPHNEA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
Sweden
1080EUCTR2004-005234-39-DK
(EUCTR)
04/08/200531/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1081NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 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 LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
1082EUCTR2005-001416-42-ES
(EUCTR)
28/07/200528/06/2005A 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 - ADAGIOA 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 LtDNULLNot 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): noPortugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1083EUCTR2004-001485-41-GB
(EUCTR)
26/07/200521/06/2005A 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/AA 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 DisordersNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Spain
1084EUCTR2004-002844-93-AT
(EUCTR)
20/07/200515/06/2005A 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 TherapyA 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 DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
1085EUCTR2004-000835-27-ES
(EUCTR)
18/07/200523/05/2006A 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.ANULLNot RecruitingFemale: yes
Male: yes
212Phase 3Spain;Italy
1086EUCTR2005-004290-19-AT
(EUCTR)
17/07/200506/12/2005A 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 diseaseA 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
100Spain;Austria;Germany;United Kingdom
1087EUCTR2005-001416-42-IT
(EUCTR)
14/07/200521/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease SubjectsA 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
TEVANULLNot RecruitingFemale: yes
Male: yes
Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1088EUCTR2005-000444-84-ES
(EUCTR)
12/07/200522/05/2006An 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-OAn 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
1089EUCTR2004-002844-93-IT
(EUCTR)
06/07/200521/09/2005A 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 LTDNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1090NCT00143026
(ClinicalTrials.gov)
July 200531/8/2005Study 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 StatesStudy to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.Parkinson's DiseaseDrug: carbidopa, levodopa, entacaponeNovartisNULLCompleted30 YearsN/AAll184Phase 4Australia;Philippines;Taiwan;Thailand
1091EUCTR2005-000444-84-AT
(EUCTR)
22/06/200518/05/2005An 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-OAn 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
1092EUCTR2005-004314-33-AT
(EUCTR)
16/06/200505/12/2005A 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 FluctuationsA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1093EUCTR2004-005234-39-SE
(EUCTR)
08/06/200502/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1094EUCTR2004-005234-39-GB
(EUCTR)
27/05/200522/03/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, 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, FinlandNULLNot 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): yesFinland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1095EUCTR2004-002641-12-GB
(EUCTR)
16/05/200530/06/2005A 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 diseaseA 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 diseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Austria;Italy;United Kingdom
1096EUCTR2004-002608-13-GB
(EUCTR)
16/05/200519/04/2005Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s diseasePragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease Parkinson's Disease with psychosisTrade Name: Seroquel
Product Name: Seroquel
Trade Name: Seroquel
Product Name: Seroquel
King’s College London & King’s College HospitalNULLNot 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): yesUnited Kingdom
1097EUCTR2004-002641-12-ES
(EUCTR)
25/04/200510/07/2006A 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 diseaseA 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 diseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Austria;Italy;United Kingdom
1098EUCTR2004-000817-20-IT
(EUCTR)
06/04/200513/04/2005A 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 TherapyA 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 LTDNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1099EUCTR2004-002844-93-ES
(EUCTR)
01/04/200504/11/2005A 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1100EUCTR2004-001593-10-GB
(EUCTR)
21/03/200525/08/2005A 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 1A 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 DiseaseProduct Name: SARIZOTAN
Product Code: EMD128130
Merck KGaANULLNot 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): noItaly;United Kingdom
1101EUCTR2004-002844-93-EE
(EUCTR)
08/03/200507/03/2005A 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1102EUCTR2004-002598-21-GB
(EUCTR)
02/03/200507/07/2005A 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 diseaseA 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 diseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Austria;United Kingdom
1103EUCTR2004-002844-93-LT
(EUCTR)
08/02/200503/01/2005A 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1104EUCTR2004-002650-59-GB
(EUCTR)
03/02/200530/06/2005A 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/aA 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 diseaseProduct Name: rotigotine
Product Code: SPM 962
INN or Proposed INN: rotigotine
SCHWARZ BIOSCIENCESNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United Kingdom
1105EUCTR2004-000817-20-AT
(EUCTR)
02/02/200529/12/2004A 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 DiseaseProduct 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Lithuania;Austria;Latvia;Italy
1106EUCTR2004-001594-25-AT
(EUCTR)
02/02/200529/12/2004A 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 2A 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Austria
1107EUCTR2004-002844-93-GB
(EUCTR)
01/02/200523/02/2005A 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain
1108EUCTR2004-002844-93-LV
(EUCTR)
28/01/200531/01/2005A 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1109EUCTR2004-002641-12-AT
(EUCTR)
21/01/200517/12/2004A 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 diseaseA 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 diseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Austria;Italy;United Kingdom
1110NCT00219284
(ClinicalTrials.gov)
January 200530/6/2005Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's DiseaseA 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 OffParkinson's Disease With End of Dose Wearing OffDrug: Carbidopa/levodopa/entacaponeNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll359Phase 4United States;Puerto Rico
1111EUCTR2004-001594-25-FI
(EUCTR)
30/12/200426/10/2004A 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 2A 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 DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain
1112EUCTR2004-002598-21-AT
(EUCTR)
22/12/200417/11/2004A 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 diseaseA 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 DiseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Austria;United Kingdom
1113EUCTR2004-002609-66-IT
(EUCTR)
21/12/200403/03/2006A 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 diseaseA 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
60Phase 3Germany;Italy
1114EUCTR2004-000817-20-ES
(EUCTR)
10/12/200404/05/2005A 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 DiseaseProduct 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1115EUCTR2004-002609-66-DE
(EUCTR)
06/12/200422/04/2005A 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 diseaseA 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 DiseaseProduct 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Germany;Italy
1116EUCTR2004-000835-27-IT
(EUCTR)
03/12/200421/07/2005A 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 agonistA 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain;Italy
1117EUCTR2004-000833-12-ES
(EUCTR)
02/12/200423/11/2004A 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Spain;Italy
1118EUCTR2004-000833-12-IT
(EUCTR)
02/12/200415/03/2005A 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 agonistA 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 PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain;Italy
1119EUCTR2004-001593-10-IT
(EUCTR)
02/12/200403/01/2005A 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 DiseaseProduct Name: Sarizotan hydrochloride
Product Code: EMD 128130
INN or Proposed INN: Sarizotan hydrochloride
MERCK S.P.A.NULLNot RecruitingFemale: yes
Male: yes
Phase 3United Kingdom;Italy
1120EUCTR2004-000185-12-IT
(EUCTR)
02/12/200427/06/2005A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's diseaseA 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 FARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
1121EUCTR2004-000185-12-AT
(EUCTR)
25/11/200421/10/2004A 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-PDA 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;Austria;Italy;United Kingdom;Sweden
1122EUCTR2004-001594-25-ES
(EUCTR)
24/11/200402/11/2004A 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-2A 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 DiseaseProduct Name: Sarizotan
Product Code: EMD 128130
INN or Proposed INN: Sarizotan Hydrochloride
MERCK KGaANULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Austria
1123NCT01518309
(ClinicalTrials.gov)
November 17, 200416/12/2008An Open-label Safety Study of Pimavanserin in Parkinson's Disease PatientsAn Open-Label Safety Study of Pimavanserin in Parkinson's Disease PatientsParkinson's Disease PsychosisDrug: pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompletedN/AN/AAll39Phase 2United States
1124EUCTR2004-000185-12-SE
(EUCTR)
11/11/200403/09/2004A 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-PDA 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, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
1125EUCTR2004-000817-20-GB
(EUCTR)
08/11/200411/02/2005A 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 DiseaseProduct 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Phase 3Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
1126NCT03091868
(ClinicalTrials.gov)
November 3, 200421/3/2017Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa PharmacokineticsA 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 mgParkinson DiseaseDrug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1Portugal
1127NCT00243971
(ClinicalTrials.gov)
November 200424/10/2005A 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 DiseaseA 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 DiseaseParkinson's DiseaseDrug: SPM 962UCB PharmaNULLCompleted18 YearsN/ABothPhase 3Germany
1128NCT00296946
(ClinicalTrials.gov)
November 200423/2/2006Ipratropium Spray for Drooling Saliva in Parkinson's DiseasePhase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ipratropium bromide (drug)University Health Network, TorontoParkinson's Disease FoundationCompleted30 YearsN/AAll20Phase 2Canada
1129NCT01634360
(ClinicalTrials.gov)
November 20043/7/2012Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsA 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 DyskinesiasParkinson's DiseaseDrug: PerampanelEisai Inc.NULLTerminatedN/AN/AAll185Phase 2NULL
1130NCT00199394
(ClinicalTrials.gov)
November 200412/9/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseaseA 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 DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin UK, Ltd.NULLCompleted30 YearsN/ABoth405Phase 3United Kingdom
1131EUCTR2004-000361-35-IT
(EUCTR)
22/10/200423/05/2005A 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 UKNULLNot RecruitingFemale: yes
Male: yes
Czech Republic;Italy
1132EUCTR2004-000817-20-LV
(EUCTR)
22/10/200427/10/2004A 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 DiseaseProduct 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1133EUCTR2004-000361-35-CZ
(EUCTR)
18/10/200422/10/2004A 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 DiseaseProduct Name: MARS
Product Code: E2007
Other descriptive name: MARS
Other descriptive name: MARS
Other descriptive name: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
225Czech Republic;Italy
1134EUCTR2004-000148-26-ES
(EUCTR)
13/10/200416/09/2004A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden
1135EUCTR2004-000148-26-CZ
(EUCTR)
12/10/200411/10/2004A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1136EUCTR2004-000148-26-SE
(EUCTR)
29/09/200405/07/2004A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1137EUCTR2004-000185-12-FI
(EUCTR)
21/09/200423/07/2004A 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-PDA 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
1138EUCTR2004-000817-20-LT
(EUCTR)
16/09/200407/01/2005A 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 DiseaseProduct 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. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1139EUCTR2004-003355-39-AT
(EUCTR)
14/09/200408/10/2004A 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 diseaseTrade Name: Aricept 5 mg-Filmtabletten
Product Name: Aricept 5mg-Filmtabletten
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
468Austria
1140NCT00641186
(ClinicalTrials.gov)
September 200418/3/2008Trial 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 DiseaseParkinson DiseaseDrug: sodium oxybateBaylor College of MedicineJazz PharmaceuticalsCompleted30 Years75 YearsBoth30Phase 2NULL
1141NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA 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 TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
1142NCT00501969
(ClinicalTrials.gov)
August 200416/7/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's DiseaseAn 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-DopaAdvanced Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll395Phase 3Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom
1143EUCTR2004-000148-26-FI
(EUCTR)
30/07/200428/06/2004A 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/AA 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 DiseaseProduct 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.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Finland;Spain;Italy;Sweden
1144NCT00174239
(ClinicalTrials.gov)
July 20049/9/2005Study 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 DiseaseDrug: cabergoline;Drug: controlled-release levodopa / carbidopaPfizerNULLTerminated18 Years80 YearsBoth220Phase 4Australia;Italy;Spain;United Kingdom
1145EUCTR2004-000148-26-IT
(EUCTR)
14/06/200426/07/2007A 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 levodopaA 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 DiseaseINN or Proposed INN: rotigotineSCHWARZ PHARMANULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1146NCT00211588
(ClinicalTrials.gov)
June 200413/9/2005Galantamine Executive Function in Parkinson's DiseaseInvestigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's DiseaseParkinson's DiseaseDrug: galantamineMemorial Hospital of Rhode IslandOrtho-McNeil Neurologics, Inc.Active, not recruiting60 Years85 YearsBoth90N/AUnited States
1147NCT00244387
(ClinicalTrials.gov)
March 200424/10/2005Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on LevodopaA 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 LevodopaParkinson Disease, IdiopathicDrug: SPM 962UCB PharmaNULLCompleted30 YearsN/ABoth506Phase 3Germany
1148NCT01941732
(ClinicalTrials.gov)
November 200310/9/2013Motor Response to Sildenafil in PDMotor Response to Acute Challenge to Sildenafil in Parkinsons DiseaseParkinsons Disease;Erectile DysfunctionDrug: SildenafilBispebjerg HospitalNULLCompleted18 Years80 YearsMale8Phase 4Denmark
1149NCT00234676
(ClinicalTrials.gov)
October 20035/10/2005POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's DiseaseA 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 DiseaseParkinson's DiseaseDrug: Premarin ®The Parkinson Study GroupWyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman FoundationCompletedN/A75 YearsFemale23Phase 2United States
1150NCT00062738
(ClinicalTrials.gov)
June 200312/6/2003Treatment of Depression in Parkinson's Disease TrialTreatment of Depression in Patients With Parkinson's DiseaseParkinson Disease;DepressionDrug: paroxetine;Drug: Nortriptyline;Other: placeboRutgers, The State University of New JerseyGlaxoSmithKlineCompleted35 Years80 YearsAll52Phase 2United States
1151NCT00381472
(ClinicalTrials.gov)
June 200326/9/2006Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopaA 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-dopaParkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 YearsN/AAll393Phase 3United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain
1152NCT00237263
(ClinicalTrials.gov)
February 20037/10/2005An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United StatesAn Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-offParkinson's DiseaseDrug: EntacaponeNovartisNULLCompleted20 YearsN/AAll285Phase 2United States
1153NCT00209508
(ClinicalTrials.gov)
November 200213/9/20052 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PDRandomized, 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 DiseaseDrug: GPI 1485Eisai Inc.Symphony Neuro Development CompanyCompleted40 Years80 YearsBoth200Phase 2NULL
1154NCT00407212
(ClinicalTrials.gov)
January 200230/11/2006A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and EfficacyA 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 DiseaseParkinson's DiseaseDrug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)NovartisNULLCompleted30 Years80 YearsBoth301Phase 1/Phase 2United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom
1155NCT00037830
(ClinicalTrials.gov)
November 199922/5/2002GM1 Ganglioside Effects on Parkinson's DiseaseThe Study of GM1 Ganglioside, A Potential New Parkinson's Disease MedicationParkinson DiseaseDrug: GM1 ganglioside;Drug: PlaceboThomas Jefferson UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed39 Years85 YearsAll94Phase 2United States
1156NCT02177357
(ClinicalTrials.gov)
November 199824/6/2014Pramipexole in Untreated and Levodopa-treated Parkinson's Disease PatientsPramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational StudyParkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/ABoth150Phase 3NULL
1157NCT00203060
(ClinicalTrials.gov)
July 199713/9/2005Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With LevodopaA 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 LevodopaParkinson's DiseaseDrug: Rasagiline Mesylate;Drug: placeboTeva Neuroscience, Inc.NULLCompleted35 YearsN/ABoth404Phase 3United States
1158EUCTR2006-006907-35-DE
(EUCTR)
30/01/2007Long-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 RECOVERLong-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1159EUCTR2010-022200-46-DE
(EUCTR)
13/04/2011Efficacy 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Latvia;Germany
1160EUCTR2009-013552-72-DE
(EUCTR)
23/08/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United 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
1161EUCTR2009-014341-84-DE
(EUCTR)
07/10/2009Non-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 GroupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
1162EUCTR2008-004447-11-DE
(EUCTR)
17/10/2008A 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 DiseaseA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2Germany;Italy;United Kingdom
1163EUCTR2006-001755-36-DE
(EUCTR)
15/08/2006Efficacy 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 - SENSEEfficacy 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
1164EUCTR2008-005492-94-DE
(EUCTR)
11/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-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 PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United 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
1165EUCTR2011-002073-30-DE
(EUCTR)
20/09/2011Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-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 AGNULLNot RecruitingFemale: yes
Male: yes
63France;United States;Hungary;Canada;Spain;Germany;Italy