Sa    (DrugBank: -)

5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病1076
30遠位型ミオパチー10
60再生不良性貧血74
118脊髄髄膜瘤4
298遺伝性膵炎23

6. パーキンソン病 [臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198
Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1076 / 2,123 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs041190126
01/02/202110/03/2020Study 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 DevelopmentPending>= 50age old< 80age oldBoth30Phase 2Japan
2NCT04625361
(ClinicalTrials.gov)
January 1, 20219/11/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult SubjectsA Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese SubjectsParkinson DiseaseDrug: HEC122505MsOHSunshine Lake Pharma Co., Ltd.NULLNot yet recruiting18 Years45 YearsAll102Phase 1China
3NCT04373317
(ClinicalTrials.gov)
January 1, 202129/4/2020Pimavanserin 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
4NCT04377945
(ClinicalTrials.gov)
December 1, 20204/5/2020Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual ComponentsA Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual ComponentsDyskinesia, Drug-InducedDrug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, Placebo Group;Drug: Part 2, JM-010 component Group CBukwang PharmaceuticalNULLNot yet recruiting18 Years80 YearsAll188Phase 2United States
5NCT04651153
(ClinicalTrials.gov)
December 202025/11/2020A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: UCB7853;Other: PlaceboUCB Biopharma SRLNULLNot yet recruiting18 Years80 YearsAll64Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04658186
(ClinicalTrials.gov)
December 20201/12/2020A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's DiseaseA Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's DiseaseEarly-stage Parkinson's DiseaseDrug: UCB0599;Drug: PlaceboUCB Biopharma SRLNULLNot yet recruiting40 Years70 YearsAll300Phase 2NULL
7NCT04147949
(ClinicalTrials.gov)
December 202027/10/2019AV-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
8EUCTR2019-003315-60-NL
(EUCTR)
10/11/202008/10/2020A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration 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: Apo-go
Product Name: APO-go®
INN or Proposed INN: Apomorphine
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Product Name: APORON
INN or Proposed INN: APORON
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Criceto IKM B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2Netherlands
9EUCTR2019-004235-23-NL
(EUCTR)
09/11/202026/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;Italy;United Kingdom;Japan
10EUCTR2019-002952-17-CZ
(EUCTR)
04/11/202012/10/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04542499
(ClinicalTrials.gov)
October 27, 20202/9/2020Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll368Phase 3United States;Australia;Czechia;Germany;Hungary;Poland
12JPRN-jRCTs031200172
26/10/202026/10/2020Effects 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.Recruiting>= 20age oldNot applicableBoth100N/AJapan
13NCT03947216
(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;F-CRINRecruiting35 Years75 YearsAll130Phase 2France
14NCT04334317
(ClinicalTrials.gov)
October 21, 202030/3/2020Effect of TAK-071 on Falls in Participants With Parkinson Disease (PD)A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of FallsParkinson's DiseaseDrug: TAK-071;Drug: PlaceboTakedaMichael J. Fox Foundation for Parkinson's ResearchRecruiting40 Years85 YearsAll64Phase 2United States
15NCT04380142
(ClinicalTrials.gov)
October 19, 20206/5/2020Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's DiseaseA Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease PatientsParkinson's Disease (PD)Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR2000037239
2020-10-012020-08-27Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomicsConstruction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics Parkinson's diseaseGold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip;Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting5580BothTarget condition:500;Difficult condition:600China
17NCT04338997
(ClinicalTrials.gov)
October 20203/4/2020PK Study in Patients With Parkinson's Disease With IZD174An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IZD174Inflazome UK LtdNULLWithdrawn45 Years75 YearsAll0Phase 1NULL
18NCT04593511
(ClinicalTrials.gov)
October 202021/9/2020to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy VolunteersAn Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular InjectionParkinson's DiseaseDrug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4Luye Pharma Group Ltd.NULLNot yet recruiting18 Years65 YearsAll40Phase 1NULL
19EUCTR2019-004235-23-GB
(EUCTR)
15/09/202028/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Japan;United Kingdom
20NCT04476017
(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 TherapeuticsNULLRecruiting50 Years75 YearsAll22Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-002949-38-DE
(EUCTR)
07/09/202021/01/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
552Phase 3United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
22EUCTR2019-004235-23-IT
(EUCTR)
26/08/202022/10/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. - na Parkinson's Disease
MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: [ABBV-951]
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;United Kingdom;Japan;Italy
23NCT04524351
(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.ParexelRecruiting45 YearsN/AAll68Phase 1;Phase 2United States
24NCT04449484
(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: PlaceboAstraZenecaNULLRecruiting40 Years85 YearsAll36Phase 1United States
25NCT04483479
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-002951-40-DE
(EUCTR)
29/07/202012/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
27NCT04630860
(ClinicalTrials.gov)
July 7, 20205/11/2020A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PDA Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLRecruiting18 Years80 YearsAll30Phase 1China
28EUCTR2019-002951-40-HU
(EUCTR)
02/07/202029/04/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden
29EUCTR2018-004156-37-PT
(EUCTR)
16/06/202009/12/2019A 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
Trade Name: IR LD/CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
30EUCTR2018-004156-37-NL
(EUCTR)
14/06/202013/01/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04428112
(ClinicalTrials.gov)
June 5, 20209/6/2020Rural Dementia Caregiver ProjectEvaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related DementiasDepression;Stress, Psychological;Self Efficacy;Loneliness;Social Isolation;Health Care Utilization;Dementia;Dementia Alzheimers;Dementia of Alzheimer Type;Dementia, Vascular;Dementia Frontal;Dementia, Lewy Body;Dementia, Mixed;Dementia in Parkinsons Disease;Dementia, HIV;Dementia Frontotemporal;Dementia, Multi-InfarctBehavioral: Building Better Caregivers Workshop;Behavioral: Attention ControlUniversity of California, San FranciscoNational Institute on Aging (NIA)Recruiting18 YearsN/AAll640N/AUnited States
32EUCTR2019-002951-40-CZ
(EUCTR)
03/06/202025/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
33NCT04379050
(ClinicalTrials.gov)
May 19, 20201/5/2020Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's DiseaseAn Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLEnrolling by invitation30 YearsN/AAll121Phase 3United States;Australia;Belgium;Canada;Denmark;Italy;Japan;Netherlands;Spain;United Kingdom
34EUCTR2018-004156-37-SE
(EUCTR)
18/05/202010/09/2019A 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
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
35EUCTR2019-002949-38-PL
(EUCTR)
13/05/202020/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04571164
(ClinicalTrials.gov)
May 11, 202021/9/2020A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDA Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDParkinson DiseaseDrug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheresLuye Pharma Group Ltd.ParexelRecruiting30 YearsN/AAll294Phase 3China
37EUCTR2018-002144-85-DE
(EUCTR)
07/05/202006/06/2019Parkinson'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 DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan
38EUCTR2019-002950-22-HU
(EUCTR)
06/05/202012/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's DiseaseA Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
296Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany
39EUCTR2018-004156-37-SK
(EUCTR)
30/04/202013/02/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Levodopa/Carbidopa Solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
40EUCTR2018-004156-37-BE
(EUCTR)
27/04/202003/03/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-002233-37-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, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
42EUCTR2019-002951-40-ES
(EUCTR)
14/04/202006/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
43EUCTR2019-002949-38-ES
(EUCTR)
07/04/202028/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
44NCT04167540
(ClinicalTrials.gov)
April 1, 20207/11/2019GDNF Gene Therapy for Parkinson's DiseaseOpen-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's DiseaseParkinson's DiseaseBiological: AAV2-GDNFBrain Neurotherapy Bio, Inc.NULLRecruiting35 Years75 YearsAll12Phase 1United States
45NCT04269642
(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.NULLRecruiting40 Years75 YearsAll99Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2018-003941-41-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
47EUCTR2019-002949-38-CZ
(EUCTR)
04/03/202019/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
48NCT04127695
(ClinicalTrials.gov)
March 3, 20209/10/2019A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ABBV-0805;Drug: Placebo ABBV-0805AbbVieNULLWithdrawnN/A85 YearsAll0Phase 1United States;Puerto Rico
49NCT04353947
(ClinicalTrials.gov)
March 2, 202016/4/2020Induction and Recognition of EmotionsInduction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's DiseaseHealthy Older Adults;Alzheimer's Disease;Parkinson's DiseaseDiagnostic Test: Mini Cognitive Examination (MCE);Diagnostic Test: Beck Depression Inventory-II (BDI-II);Diagnostic Test: Global Deterioration Scale (GDS);Diagnostic Test: Memory alteration test (M@T);Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC);Diagnostic Test: Barcelona test (BT);Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT);Diagnostic Test: Frontal assessment battery (FAB);Diagnostic Test: Positive and Negative Affect Scale (PANAS);Diagnostic Test: Auto-Assessment Manikins (SAM)University of ValenciaAsociación Parkinson ValenciaRecruiting65 Years99 YearsAll60Spain
50EUCTR2018-004156-37-AT
(EUCTR)
02/03/202005/11/2019A 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
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04154072
(ClinicalTrials.gov)
February 27, 20204/11/2019A Clinical Study of NLY01 in Patient's With Early Parkinson's DiseaseMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's DiseaseParkinson DiseaseDrug: NLY01;Drug: VehicleNeuraly, Inc.NULLRecruiting30 Years80 YearsAll240Phase 2United States;Canada
52NCT04291859
(ClinicalTrials.gov)
February 26, 202028/2/2020Lu AF28996 in Patients With Parkinson's Disease (PD)Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Lu AF28996H. Lundbeck A/SNULLRecruiting45 Years75 YearsAll10Phase 1Netherlands
53EUCTR2018-004156-37-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]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;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
54EUCTR2019-002949-38-HU
(EUCTR)
06/02/202017/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's DiseaseProduct Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden
55EUCTR2018-002234-21-GB
(EUCTR)
05/02/202004/07/2019An 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
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 finishedFemale: yes
Male: yes
300Phase 3France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04251585
(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
57EUCTR2018-003941-41-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
58EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
59NCT04220762
(ClinicalTrials.gov)
January 21, 202017/12/2019A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease PatientsA Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II StudyParkinson DiseaseDrug: WIN-1001X;Drug: PlaceboMedi Help LineNULLRecruiting30 YearsN/AAll188Phase 2Korea, Republic of
60NCT04369430
(ClinicalTrials.gov)
January 16, 202013/4/2020Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentParkinson DiseaseDrug: AKST4290;Drug: PlaceboAlkahest, Inc.NULLRecruiting50 Years80 YearsAll120Phase 2United States;Estonia;Germany;Poland;Slovakia;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2018-004156-37-GB
(EUCTR)
14/01/202013/09/2019A 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 finishedFemale: yes
Male: yes
350Phase 3Serbia;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
62EUCTR2019-001657-42-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Hungary;Estonia;Slovakia;Poland;Germany
63EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
64NCT04295642
(ClinicalTrials.gov)
January 8, 202024/1/2020A 2-Part Trial of CVL-751 in Subjects With Parkinson's DiseaseA 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: CVL-751Cerevel Therapeutics, LLCNULLRecruiting45 Years75 YearsAll33Phase 1United States
65NCT04223193
(ClinicalTrials.gov)
January 6, 20207/1/2020Flexible-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll296Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT04127578
(ClinicalTrials.gov)
January 3, 202014/10/2019Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 MutationParkinson DiseaseBiological: PR001A;Drug: Methylprednisolone;Drug: Sirolimus;Drug: PrednisonePrevail TherapeuticsNULLRecruiting35 Years80 YearsAll12Phase 1;Phase 2United States
67NCT04301492
(ClinicalTrials.gov)
January 1, 202017/2/2020Tolerability, Safety and Efficacy of VortioxetineTolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label StudyDepressionDrug: VortioxetineIRCCS San RaffaeleNULLRecruiting30 Years80 YearsAll20Phase 4Italy
68NCT04152655
(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 UniversityNULLRecruiting18 YearsN/AAll180Phase 2;Phase 3China
69NCT03446807
(ClinicalTrials.gov)
January 202020/2/2018Safety 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
70EUCTR2018-004156-37-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]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04201093
(ClinicalTrials.gov)
December 13, 201913/12/2019Fixed-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll522Phase 3United States;Australia
72NCT04183634
(ClinicalTrials.gov)
December 3, 201928/11/2019An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.Parkinson DiseaseDrug: Rotigotine TTS (Test);Drug: Neupro (Reference)SandozNULLTerminated18 Years80 YearsAll31Phase 1Germany
73NCT04044131
(ClinicalTrials.gov)
December 1, 201917/7/2019Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) PatientsA Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) And Parkinson's Disease (PD) PatientsAlzheimer Disease;Parkinson DiseaseDrug: Metabolic Cofactor Supplementation;Drug: SorbitolIstanbul Medipol University HospitalScandiBio Therapeutics AB;Alanya Alaaddin Keykubat University;Sahlgrenska University Hospital, Sweden;KTH Royal Institute of TechnologyRecruiting18 YearsN/AAll120Phase 2Turkey
74EUCTR2018-004156-37-CZ
(EUCTR)
26/11/201926/09/2019A 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
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
75NCT03924414
(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;ParkinsonismDrug: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04175132
(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
77EUCTR2018-003941-41-DK
(EUCTR)
29/10/201924/06/2019This 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 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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Denmark;Australia;Bulgaria;Germany;New Zealand
78NCT04164758
(ClinicalTrials.gov)
October 23, 201913/11/2019Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineA Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineParkinson's DiseaseDrug: Pimavanserin;Other: Placebo;Drug: QuetiapineACADIA Pharmaceuticals Inc.NULLTerminated50 Years85 YearsAll11Phase 2United States
79EUCTR2019-001657-42-DE
(EUCTR)
22/10/201911/06/2019A study to learn how well the drug AKST4290 works and how safe AKST4290 is in people who have Parkinson's disease that are taking dopamine based medication.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on Stable Dopaminergic Treatment - N/A Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Estonia;Hungary;Slovakia;Poland;Germany
80EUCTR2018-003337-15-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]
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
504Phase 2United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT04157933
(ClinicalTrials.gov)
October 16, 20191/11/2019Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's DiseaseA Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's DiseaseParkinson's DiseaseDrug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossoverAlexza Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll35Phase 1Netherlands
82NCT04165837
(ClinicalTrials.gov)
October 14, 201913/11/2019Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsParkinson's DiseaseDrug: FB-101;Drug: Placebo1ST Biotherapeutics, Inc.NULLRecruiting19 Years55 YearsAll48Phase 1United States
83EUCTR2018-002233-37-GB
(EUCTR)
11/10/201914/02/2019Evaluate 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, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
84EUCTR2018-003941-41-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
85EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03987750
(ClinicalTrials.gov)
October 201912/6/2019Safinamide for Levodopa-induced Dyskinesia (PD-LID)A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor FluctuationsDyskinesia, Drug-Induced;Parkinson DiseaseDrug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placeboZambon SpANULLWithdrawn30 YearsN/AAll0Phase 3NULL
87EUCTR2018-002234-21-DE
(EUCTR)
23/09/201916/05/2019An 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
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 finishedFemale: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
88EUCTR2018-002144-85-NL
(EUCTR)
11/09/201927/03/2019Parkinson'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]
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
89NCT04477161
(ClinicalTrials.gov)
September 5, 201922/6/2020Effect of Ketone Esters in Parkinson's DiseaseEffect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.Parkinson Disease;KetosisDietary Supplement: Ketone Ester Elite endurance Nutrition Drink;Other: Stool SampleUniversity of FloridaNULLRecruiting40 Years75 YearsAll15N/AUnited States
90NCT03959540
(ClinicalTrials.gov)
September 201923/4/2019Safety 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.NULLNot yet recruiting75 YearsN/AAll100NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT04075318
(ClinicalTrials.gov)
August 29, 20195/8/2019Study of UB-312 in Healthy Participants and Parkinson's Disease PatientsA Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's DiseaseParkinson Disease;ParkinsonismBiological: UB-312;Biological: PlaceboUnited Neuroscience Ltd.Centre for Human Drug Research, Netherlands;Worldwide Clinical TrialsActive, not recruiting40 Years85 YearsAll62Phase 1Netherlands
92NCT04006210
(ClinicalTrials.gov)
August 27, 201930/6/2019A 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).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)Parkinson's DiseaseCombination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mgNeuroDerm Ltd.NULLRecruiting30 Years80 YearsAll380Phase 3United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Ukraine;United Kingdom
93EUCTR2018-003941-41-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 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
94EUCTR2018-002234-21-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]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
95EUCTR2018-002144-85-BE
(EUCTR)
20/08/201924/04/2019Parkinson'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 DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2018-003941-41-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
97NCT03976349
(ClinicalTrials.gov)
August 12, 20194/6/2019A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's DiseaseA Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB094;Drug: PlaceboBiogenIonis Pharmaceuticals, Inc.Recruiting35 Years80 YearsAll82Phase 1United States;Canada;Israel;Norway;Spain;United Kingdom
98NCT04043338
(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 PharmaceuticalsCelerionRecruiting18 Years75 YearsAll40Phase 1United States
99EUCTR2018-003941-41-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 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
100NCT03881371
(ClinicalTrials.gov)
August 1, 201918/3/2019A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaParkinson DiseaseDrug: Safinamide;Other: PlaceboZambon SpANULLRecruiting18 YearsN/AAll306Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2018-003941-41-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 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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: 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
102EUCTR2018-002144-85-GB
(EUCTR)
29/07/201913/03/2019Parkinson'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 DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom
103NCT04056689
(ClinicalTrials.gov)
July 23, 201912/8/2019Study to Evaluate DNL151 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DNL151;Drug: PlaceboDenali Therapeutics Inc.NULLActive, not recruiting30 Years75 YearsAll34Phase 1United States;Belgium;Netherlands;United Kingdom
104NCT03956979
(ClinicalTrials.gov)
July 22, 201917/5/2019A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiAA 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-010DyskinesiasDrug: JM-010 group A;Drug: JM-010 group B;Drug: PlacebosContera PharmaBukwang PharmaceuticalRecruiting18 Years80 YearsAll81Phase 2Germany
105EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03575195
(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
107EUCTR2018-002144-85-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 DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
108EUCTR2018-002144-85-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 DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Australia;Denmark;Netherlands;United Kingdom;Japan
109EUCTR2018-003941-41-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 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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: 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
110EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03977441
(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
112EUCTR2018-003289-15-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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany
113EUCTR2018-003337-15-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]
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
504Phase 2United States;Hungary;Slovakia;Poland;Spain;India
114EUCTR2018-002234-21-CZ
(EUCTR)
14/06/201930/05/2019 An 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]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
115EUCTR2018-003337-15-SK
(EUCTR)
05/06/201926/04/2019A 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 finishedFemale: yes
Male: yes
504Phase 2United States;Hungary;Slovakia;Poland;Spain;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2018-003289-15-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 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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Denmark;Germany
117NCT03971617
(ClinicalTrials.gov)
May 29, 201930/5/2019Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Hydrogen;Drug: Placebo oral tabletStony Brook UniversityNULLRecruiting40 Years80 YearsAll70Phase 2;Phase 3United States
118EUCTR2018-003289-15-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
119NCT03671785
(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 FoundationRecruiting55 Years75 YearsAll12Phase 1United States
120NCT04293159
(ClinicalTrials.gov)
May 14, 201919/2/2020Effect of Probiotic on Constipation in Patients With Parkinson's DiseaseEffect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's DiseaseParkinson Disease;ConstipationDietary Supplement: Lactobacillus casei DG (Enterolactis duo®)University of SalernoRoberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina CiacciRecruiting18 Years75 YearsAll30N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-003289-15-GB
(EUCTR)
08/05/201928/12/2018This 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 - 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
122NCT03781167
(ClinicalTrials.gov)
April 29, 201918/12/2018A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects 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-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France
123NCT03899324
(ClinicalTrials.gov)
April 26, 201929/3/2019Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's DiseaseA Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's DiseaseParkinson DiseaseDrug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tabletB&A TherapeuticsNULLRecruiting40 Years80 YearsAll40Phase 2France
124JPRN-JapicCTI-194763
22/4/201920/05/2019Safety and PK study of LY03003An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. Parkinson's DiseaseIntervention name : Rotigotine
INN of the intervention : Rotigotine
Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week.
Control intervention name : Rotigotine
INN of the control intervention : Rotigotine
Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day.
Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd.NULLcomplete20BOTH32Phase 1Japan
125EUCTR2018-002233-37-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, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03661125
(ClinicalTrials.gov)
April 11, 20194/9/2018SRC Inhibition as a Potential Target for Parkinson's Disease PsychosisA Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.Parkinson Disease PsychosisDrug: Saracatinib;Drug: Placebo Oral TabletKing's College LondonAstraZeneca;King's College Hospital NHS TrustRecruiting40 YearsN/AAll30Early Phase 1United Kingdom
127EUCTR2018-003289-15-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 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]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
128NCT03841604
(ClinicalTrials.gov)
April 9, 201930/1/2019Effect of Safinamide on Parkinson's Disease Related Chronic PainA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic PainIdiopathic Parkinson DiseaseDrug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placeboZambon SpANULLRecruiting30 YearsN/AAll177Phase 4Austria;France;Germany;Italy;Spain
129EUCTR2016-000657-12-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
130NCT03877510
(ClinicalTrials.gov)
April 3, 201912/3/2019Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor FluctuationsAn Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mgImpax Laboratories, LLCNULLEnrolling by invitation40 YearsN/AAll300Phase 3United States;Czechia;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131ChiCTR1800015757
2019-04-012018-04-18Value of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's diseaseValue of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's disease Parkinson's DiseaseGold Standard:PD diagnostic criteria made by MDS in 2016;Index test:reduced uptake in salivery gland and myocardium in I-131-MIBG scintigraphic imaging;Tongji hospital, Tongji UniversityNULLPendingBothTarget condition:30;Difficult condition:30China
132NCT03922711
(ClinicalTrials.gov)
March 26, 201917/4/2019A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's DiseaseA Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)Parkinson DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLTerminated30 Years85 YearsAll23Phase 2United States
133NCT03716570
(ClinicalTrials.gov)
March 12, 201922/10/2018A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's DiseaseA Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB054;Drug: PlaceboBiogenNULLActive, not recruiting40 Years80 YearsAll24Phase 1Japan
134EUCTR2017-005170-19-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
135NCT03655236
(ClinicalTrials.gov)
February 18, 201918/8/2018PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's DiseaseEarly Parkinson DiseaseDrug: K0706;Other: placeboSun Pharma Advanced Research Company LimitedNULLRecruiting50 YearsN/AAll504Phase 2United States;Hungary;Poland;Slovakia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03968744
(ClinicalTrials.gov)
February 18, 201919/4/2019Effect of Safinamide on Sleep Quality in Patients With Parkinson's DiseaseA Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep StudyIdiopathic Parkinson's Disease (at Later Stage)Drug: SafinamideAlain KaelinClinical Trial Unit Ente Ospedaliero CantonaleRecruiting18 YearsN/AAll23Phase 4Switzerland
137NCT03413384
(ClinicalTrials.gov)
February 15, 20198/1/2018To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaA Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ceftriaxone;Other: PlaceboBrainX CorporationNULLRecruiting50 Years80 YearsAll106Phase 2Taiwan
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
139NCT03790670
(ClinicalTrials.gov)
January 30, 201918/12/2018Biomarker Assessments of Leukine During Treatment of Parkinson's DiseaseSafety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot StudyParkinson DiseaseDrug: sargramostimUniversity of NebraskaNULLRecruiting35 Years85 YearsAll10Phase 1United States
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: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Zambon SpANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
177Phase 4Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03840005
(ClinicalTrials.gov)
December 18, 201811/2/2019Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP StudyA Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD)Parkinson's DiseaseDrug: UrsonormSheffield Teaching Hospitals NHS Foundation TrustJP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of SheffieldActive, not recruiting18 Years75 YearsAll30Phase 2United Kingdom
142NCT03781791
(ClinicalTrials.gov)
December 10, 201827/11/2018Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)Constipation;Parkinson DiseaseDrug: Active Investigational Treatment ENT-01;Drug: Placebo TreatmentEnterin Inc.NULLActive, not recruiting30 Years90 YearsAll152Phase 2United States
143NCT03710707
(ClinicalTrials.gov)
December 4, 201815/10/2018Study to Evaluate DNL201 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: DNL201;Drug: PlaceboDenali Therapeutics Inc.NULLCompleted30 Years80 YearsAll29Phase 1United States
144NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
145NCT03639064
(ClinicalTrials.gov)
December 20184/7/2018Cannabis Oil for Pain in Parkinson's DiseaseA Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's DiseaseParkinson DiseaseDrug: Cannabis OilUniversity Health Network, TorontoParkinson Society CanadaUnknown status18 YearsN/AAll15Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03822364
(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
147NCT03823638
(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
148NCT03713957
(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
149EUCTR2018-001887-46-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]
Sheffield Teaching Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30Phase 2United Kingdom
150NCT03670953
(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, LLCNULLRecruiting40 YearsN/AAll510Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT03667404
(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
152NCT04629404
(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
153JPRN-JapicCTI-184181
01/11/201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety Parkinson's diseaseIntervention name : Rasagiline
INN of the intervention : rasagiline
Dosage And administration of the intervention : Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLcompleteBOTH1021NAJapan
154NCT03727139
(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: RasagilineTakedaNULLActive, not recruitingN/AN/AAll1021Japan
155EUCTR2017-003415-19-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2016-002033-30-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]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
157EUCTR2017-002426-20-ES
(EUCTR)
19/10/201820/08/2018Effect 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 SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
177Phase 4Spain
158NCT03720418
(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 in Patients With Bilateral Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: OXB-102;Other: Imitation Surgical Procedure (ISP)Axovant Sciences Ltd.Oxford BioMedicaRecruiting30 Years70 YearsAll30Phase 1;Phase 2France;United Kingdom
159EUCTR2018-000346-19-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
160EUCTR2016-004610-95-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03665454
(ClinicalTrials.gov)
September 24, 20181/8/2018PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseA Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseParkinson DiseaseDrug: PF-06412562;Drug: Standard of Care PlaceboMilton S. Hershey Medical CenterPfizerCompletedN/AN/AAll8Phase 1United States
162NCT04202757
(ClinicalTrials.gov)
September 14, 201821/9/2018Intravenous Plasma Treatment for Parkinson's DiseaseIntravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease - Randomized Controlled StudyIdiopathic Parkinson DiseaseBiological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors;Other: SalineThe Neurology CenterCarolina Longevity InstituteCompleted45 Years90 YearsAll18Phase 4United States
163NCT03608371
(ClinicalTrials.gov)
August 31, 20189/5/2018BTRX-246040 Study in Subjects With Parkinson's Disease With Motor FluctuationsPhase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor FluctuationsParkinson Disease;Motor DisorderDrug: BTRX-246040;Drug: PlaceboBlackThorn Therapeutics, Inc.NULLCompleted30 Years76 YearsAll24Phase 2United States
164EUCTR2016-004610-95-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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
311Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom;Sweden
165NCT03773796
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT04455555
(ClinicalTrials.gov)
August 1, 201828/6/2020Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseEfficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseParkinson's DiseaseDrug: LY03003( the name of rotigotine);Other: PlaceboPeking University Third HospitalNULLCompleted18 YearsN/AAll294Phase 3China
167JPRN-JMA-IIA00385
01/08/201812/09/2018Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's DiseaseKyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease Parkinson's diseaseIntervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value..Kyoto University HospitalNULLTemporarily Closed>=50 YEARS<70 YEARSBOTH7Phase 3Japan
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 2Finland;Sweden
169NCT03611569
(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/SNULLRecruiting18 Years80 YearsAll84Phase 1United States
170NCT03624920
(ClinicalTrials.gov)
July 12, 201810/7/2018Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessSafety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessParkinson DiseaseDrug: THN102 Dosage A;Drug: THN102 Dosage B;Drug: THN102 Dosage CTheranexusNULLCompleted18 Years80 YearsAll77Phase 2United States;Czechia;France;Germany;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03774459
(ClinicalTrials.gov)
July 9, 20188/12/2018ANAVEX2-73 Study in Parkinson's Disease DementiaA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With DementiaParkinsons Disease With DementiaDrug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsuleAnavex Life Sciences Corp.Anavex Germany GmbHCompleted50 Years85 YearsAll132Phase 2Australia;Spain
172NCT03775538
(ClinicalTrials.gov)
July 5, 201811/10/2018Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical StudyA 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-2002Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll15Phase 1;Phase 2Finland;Sweden
173EUCTR2017-004335-36-ES
(EUCTR)
04/07/201811/04/2018A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients.A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. - A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 Cognition in Parkinson’s Disease with dementia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: ANAVEX2-73
INN or Proposed INN: ANAVEX2-73
Product Name: ANAVEX2-73
INN or Proposed INN: ANAVEX2-73
Anavex Life Sciences Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2Spain
174NCT03521635
(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
175NCT03562494
(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 TherapeuticsRecruiting40 Years75 YearsAll85Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2017-001420-21-DE
(EUCTR)
18/06/201816/02/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
177EUCTR2017-001420-21-ES
(EUCTR)
13/06/201815/03/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
178NCT03439943
(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
179EUCTR2018-000346-19-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
180NCT03891069
(ClinicalTrials.gov)
June 1, 201818/3/2019Feasibility of the AHA Exergame System in Parkinson's Disease PatientsFeasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods StudyParkinson DiseaseDevice: AHA Exergame SystemCampus Neurológico SéniorUniversity of LisbonCompleted40 Years80 YearsAll10N/APortugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT03684122
(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 JordanNULLRecruiting20 Years75 YearsAll10Phase 1;Phase 2Jordan
182NCT03532984
(ClinicalTrials.gov)
June 1, 201827/4/2018Beam Walking Across the Lifespan for Falls PredictionBeam Walking to Assess Dynamic Balance in Health and Disease: A Protocol for the 'BEAM' Multi-center Observational StudyAging;Parkinson Disease;Stroke;Dementia;Diagnoses Disease;Cognitive Impairment;Postural; DefectDiagnostic Test: Beam test to predict fallsUniversity Medical Center GroningenDokkyo Medical University;University of Potsdam;Somogy Megyei Kaposi Mór Teaching Hospital;University of Sao PauloUnknown status20 Years80 YearsAll432Brazil;Germany;Hungary;Japan;Netherlands
183EUCTR2016-004610-95-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
311Phase 2France;United States;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom;Sweden
184EUCTR2017-004475-31-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]
Theranexus S.A.NULLNot Recruiting Female: yes
Male: yes
60Phase 2France;United States;Hungary;Czech Republic;Germany
185NCT03541356
(ClinicalTrials.gov)
May 8, 20185/4/2018Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off ReversalA Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease PatientsParkinson's DiseaseCombination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mgImpel NeuroPharma Inc.NULLCompleted40 Years80 YearsAll32Phase 2Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2016-004610-95-GB
(EUCTR)
01/05/201827/12/2017Evaluating 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom
187NCT03843944
(ClinicalTrials.gov)
May 1, 201812/2/2019Overnight Switch From Rasagiline To SafinamideOvernight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety StudyParkinson DiseaseDrug: SafinamideIRCCS San RaffaeleNULLCompleted30 Years80 YearsAll20Phase 4Italy
188NCT03374917
(ClinicalTrials.gov)
April 18, 20188/12/2017A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient EnvironmentAn Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient EnvironmentParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted30 Years85 YearsAll20Phase 1United States
189EUCTR2017-004475-31-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
190EUCTR2017-004253-16-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]
Medizinische Universität Innsbruck, Universitätsklinik für NeurologieNULLNot Recruiting Female: yes
Male: yes
48Phase 3Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2017-002707-10-DK
(EUCTR)
10/04/201803/11/2017Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effectsSerum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10075174;Term: Mixed dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Memantin Orion
INN or Proposed INN: MEMANTINE
Product Name: Donepezil Sandoz
Product Code: 25330
INN or Proposed INN: DONEPEZIL
Regional Dementia Research Centre, Dept of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 4Denmark
192NCT03648671
(ClinicalTrials.gov)
March 28, 201826/6/2018Pain in Parkinson's Disease With Motor Fluctuations.Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.Parkinson DiseaseDrug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)Universita di VeronaAzienda Ospedaliera Universitaria Integrata VeronaUnknown status18 Years80 YearsAll48Italy
193EUCTR2016-004610-95-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
194NCT03482882
(ClinicalTrials.gov)
March 9, 201823/3/2018Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionAn Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and DepressionTreatment of Depression in Adults With Parkinson's Disease (PD)Drug: PimavanserinACADIA Pharmaceuticals Inc.NULLCompleted50 YearsN/AAll47Phase 2United States
195NCT03496870
(ClinicalTrials.gov)
February 8, 20181/3/2018A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Carbidopa LevodopaNeurocrine BiosciencesNULLCompleted18 Years85 YearsAll16Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT03189563
(ClinicalTrials.gov)
February 6, 201812/6/2017Safety and Efficacy of DA-9805 for Parkinson's DiseaseA Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DA-9805 45mg;Drug: DA-9805 90mg;Other: PlaceboDong-A ST Co., Ltd.NULLCompleted30 Years79 YearsAll60Phase 2United States
197EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
198EUCTR2016-000637-43-AT
(EUCTR)
01/02/201815/12/2017Safety, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;United Kingdom;Italy
199JPRN-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
200NCT03329508
(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 DiseaseDrug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ERPharma Two B Ltd.NULLRecruiting35 Years80 YearsAll525Phase 3United States;Canada;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03331848
(ClinicalTrials.gov)
January 15, 20181/11/2017Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - 20mgPrexton TherapeuticsNULLWithdrawn35 Years85 YearsAll0Phase 2NULL
202NCT03318523
(ClinicalTrials.gov)
January 10, 201819/10/2017Evaluating 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 DiseaseParkinson's DiseaseDrug: Placebo;Drug: BIIB054BiogenNULLActive, not recruiting40 Years80 YearsAll357Phase 2United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom
203NCT03550183
(ClinicalTrials.gov)
January 10, 201811/5/2018Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's DiseaseSafety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsParkinson's DiseaseBiological: mesenchymal stem cellsHebei Newtherapy BIo-Pharma technology Co., Ltd.NULLEnrolling by invitation40 Years80 YearsAll20Phase 1China
204EUCTR2017-000877-35-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
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)US WorldMeds LLCNULLCompleted30 Years80 YearsAll209United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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]
NeuroDerm Ltd.NULLNot Recruiting Female: 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
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
208EUCTR2016-002033-30-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
209EUCTR2017-000877-35-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
210NCT03272165
(ClinicalTrials.gov)
October 17, 201729/6/2017Single Ascending Dose Study of MEDI1341 in Healthy VolunteersA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers.Parkinson's DiseaseDrug: MEDI1341;Drug: PlaceboAstraZenecaCovance;MMS Holdings, Inc;CatalentRecruiting18 Years80 YearsAll48Phase 1United States;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03205488
(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
212NCT04045678
(ClinicalTrials.gov)
October 10, 201730/7/2019A Multiple Ascending Dose Study With 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: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll30Phase 1China
213NCT03250117
(ClinicalTrials.gov)
October 10, 201711/8/2017Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral RopiniroleAn Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-DopaParkinson DiseaseDrug: Ropinirole oral product;Drug: Ropinirole ImplantTitan PharmaceuticalsNULLTerminated30 Years80 YearsAll3Phase 1;Phase 2United States
214EUCTR2017-001673-17-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
215ChiCTR1800019216
2017-09-302018-10-31Study for accurate diagnosis and treatment of Parkinson's disease by using the combination of TMS-EEGStudy for accurate diagnosis and treatment of Parkinson's disease by using the combination of TMS-EEG Parkinson's diseaseBradykinesia Group:Sick side, SAM region, 10Hz rTMS;Tremor Group:Sick side, M1 region, 1Hz rTMS;Health control:N/A;Shenzhen People's HospitalNULLRecruiting5080BothBradykinesia Group:30;Tremor Group:30;Health control:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03257046
(ClinicalTrials.gov)
September 28, 201714/8/2017Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's DiseaseA Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: ITI-214;Other: PlaceboIntra-Cellular Therapies, Inc.NULLCompleted50 YearsN/AAll40Phase 1;Phase 2United States
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
218NCT03295786
(ClinicalTrials.gov)
September 26, 201714/9/2017Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's DiseasePhase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's DiseaseParkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll17Phase 1;Phase 2Finland;Sweden
219EUCTR2017-000128-81-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
220NCT03306329
(ClinicalTrials.gov)
September 13, 201725/9/2017DNS-7801 vs. Placebo in Parkinson's DiseaseA Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson's Disease (PD) Subjects With Motor FluctuationsParkinson's DiseaseDrug: DNS-7801 (low-dose);Drug: DNS-7801 (high dose);Drug: PlaceboDart NeuroScience, LLCNULLTerminated30 YearsN/AAll5Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2016-003961-25-CZ
(EUCTR)
07/09/201715/05/2017A 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 TherapiesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;United Kingdom
222NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
223EUCTR2017-000128-81-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
224EUCTR2017-000877-35-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]
BenevolentAI BioNULLNot Recruiting Female: yes
Male: yes
240Phase 2United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
225EUCTR2017-000877-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2017-000877-35-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
227NCT03187301
(ClinicalTrials.gov)
August 3, 20177/6/2017A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF EpisodesA Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson's Disease;Off Episodes of Parkinson DiseaseDrug: APL-130277;Drug: Placebo;Drug: MoxifloxacinSunovionNULLCompleted18 YearsN/AAll48Phase 2United States;Italy
228NCT03026231
(ClinicalTrials.gov)
July 15, 201711/1/2017Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease PatientsA Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's DiseaseParkinson's DiseaseBiological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727)The University of Texas Health Science Center, HoustonKelsey Research FoundationWithdrawn45 Years70 YearsAll0Phase 1;Phase 2United States
229ChiCTR-IPR-17011987
2017-07-122017-07-14The effect of conduction exercise and self-acupressure in treatment of Parkinson’s disease: a pilot studyThe effect of conduction exercise and self-acupressure in treatment of Parkinson’s disease: a pilot study Parkinson's DiseaseGroup 1:CE+ SA + routine western medications;Group 2:Routine western medications only (control);HKBU School of Chinese MedicineNULLRecruiting1880BothGroup 1:29;Group 2:29;China
230NCT03555292
(ClinicalTrials.gov)
July 12, 201724/4/201811C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesSafety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesParkinson DiseaseDrug: 11C-PiBOriental Neurosurgery Evidence-Based-Study TeamNULLRecruiting18 YearsN/AAll200Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2017-000135-14-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany
232NCT03185481
(ClinicalTrials.gov)
July 6, 20179/6/2017Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson's Disease With Motor FluctuationsDrug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QDPfizerNULLTerminated40 Years87 YearsAll5Phase 2United States
233EUCTR2015-005814-31-BE
(EUCTR)
06/07/201705/05/2017-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: 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 finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
234NCT03162874
(ClinicalTrials.gov)
July 4, 201719/5/2017Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's PatientsA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2Prexton TherapeuticsNULLCompleted35 Years85 YearsAll157Phase 2Austria;France;Germany;Italy;Spain;United Kingdom
235EUCTR2016-003961-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT03042416
(ClinicalTrials.gov)
June 29, 20171/2/201718F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety18F-DOPA PET Imaging: an Evaluation of Biodistribution and SafetyCongenital Hyperinsulinism;Neuroblastoma;Neuroendocrine Tumors;Parkinson Disease;Brain GliomaDrug: 18F-DOPAUniversity of AlbertaAlberta Health ServicesActive, not recruitingN/AN/AAll400Phase 3Canada
237NCT04223245
(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
238EUCTR2015-005814-31-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
239EUCTR2017-000135-14-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
240EUCTR2015-005814-31-HU
(EUCTR)
14/06/201720/04/2017-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2016-003961-25-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
242EUCTR2017-000135-14-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
243EUCTR2016-003961-25-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
244EUCTR2017-000135-14-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
245EUCTR2017-000135-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2015-005814-31-PL
(EUCTR)
25/05/201714/02/2017-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: 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 finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
247NCT03033498
(ClinicalTrials.gov)
May 17, 201725/1/2017A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseA Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted45 Years85 YearsAll29Phase 1United States
248NCT03047629
(ClinicalTrials.gov)
May 11, 20173/2/2017Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related ConstipationA Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related ConstipationParkinson's Disease;ConstipationDrug: ENT-01;Other: PlaceboEnterin Inc.NULLCompleted30 Years86 YearsAll50Phase 1;Phase 2United States
249NCT03065192
(ClinicalTrials.gov)
May 11, 201710/2/2017Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Using a Posterior Trajectory Into the Putamen of Participants With Parkinson's Disease With Fluctuating Responses to LevodopaIdiopathic Parkinson's Disease;Parkinson's Disease;Basal Ganglia Disease;Brain Diseases;Central Nervous System Diseases;Movement Disorders;Nervous System Diseases;Neurodegenerative Diseases;Parkinsonian DisordersDrug: VY-AADC01Neurocrine BiosciencesVoyager TherapeuticsActive, not recruiting40 Years75 YearsAll16Phase 1United States
250EUCTR2015-004507-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT03119636
(ClinicalTrials.gov)
May 20176/4/2017Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's DiseaseA Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NPC transplantation;Drug: LevodopaChinese Academy of SciencesThe First Affiliated Hospital of Zhengzhou UniversityRecruiting50 Years80 YearsAll50Phase 1;Phase 2China
252NCT03425877
(ClinicalTrials.gov)
April 22, 201710/1/2018Arousal Response Tool for Neurological DiseaseArousal Response Tool for Neurological DiseaseParkinson Disease;Stroke;HealthyDevice: MS Band 2;Behavioral: Emotion Assessment;Behavioral: Single Task;Behavioral: Dual Task;Behavioral: RestIRCCS San Camillo, Venezia, ItalyUniversità Politecnica delle Marche;University of PadovaUnknown status25 YearsN/AAll45N/AItaly
253NCT03128450
(ClinicalTrials.gov)
April 15, 20179/2/2017A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease PatientA Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's DiseaseParkinson DiseaseBiological: human neural stem cellSecond Affiliated Hospital of Soochow UniversityNULLEnrolling by invitation35 Years70 YearsAll12Phase 2;Phase 3China
254NCT03051607
(ClinicalTrials.gov)
April 10, 20179/2/2017Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-OffIdiopathic Parkinson DiseaseDrug: TozadenantBiotie Therapies Inc.Acorda TherapeuticsTerminated30 Years80 YearsAll66Phase 3United States;Canada;United Kingdom
255EUCTR2016-003961-25-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]
Biotie TherapiesNULLNot Recruiting Female: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT02953665
(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
257NCT02970019
(ClinicalTrials.gov)
March 30, 201718/11/2016Safety and Tolerability Study of K0706 in Subjects With Parkinson's DiseaseA Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.Parkinson DiseaseDrug: K0706;Drug: PlaceboSun Pharma Advanced Research Company LimitedNULLCompleted18 Years65 YearsAll60Phase 1United States
258EUCTR2016-001575-71-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
259EUCTR2015-005814-31-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]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
210Phase 2France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
260EUCTR2015-004507-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2016-000657-12-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2Portugal;United States;Taiwan;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Singapore;Australia;Norway;Germany;Japan;Sweden
262EUCTR2015-004344-19-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]
ApoPharmaNULLNot Recruiting Female: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
263EUCTR2015-005814-31-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]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
264EUCTR2016-000657-12-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
265EUCTR2016-000657-12-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]
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290Phase 2Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT03037203
(ClinicalTrials.gov)
January 201723/1/2017A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessA 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessExcessive Sleepiness;Parkinson DiseaseDrug: JZP-110;Other: PlaceboJazz PharmaceuticalsNULLCompleted35 Years80 YearsAll66Phase 2United States
267NCT02954978
(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
268NCT02969369
(ClinicalTrials.gov)
December 31, 201617/11/2016A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisA Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: SEP-363856;Drug: Placebo capsuleSunovionNULLCompleted55 Years105 YearsAll39Phase 2United States
269EUCTR2016-001575-71-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
270EUCTR2016-002033-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02906020
(ClinicalTrials.gov)
December 15, 201614/9/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (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.Parkinson's DiseaseDrug: GZ/SAR402671;Drug: PlaceboGenzyme, a Sanofi CompanyNULLActive, not recruiting18 Years80 YearsAll270Phase 2United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom
272ChiCTR2000037957
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
273NCT02941822
(ClinicalTrials.gov)
December 20165/9/2016Ambroxol in Disease Modification in Parkinson DiseaseA 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 DiseaseParkinson DiseaseDrug: AmbroxolUniversity College, LondonThe Cure Parkinson's TrustCompleted40 Years80 YearsAll23Phase 2United Kingdom
274NCT03000569
(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
275EUCTR2016-002033-30-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]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
150Phase 3United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276JPRN-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
277EUCTR2015-004912-39-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
278NCT02847442
(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
279EUCTR2016-000657-12-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
280NCT03531060
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2016-002033-30-ES
(EUCTR)
03/11/201625/08/2016A 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: 19.0;Level: PT;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 finishedFemale: yes
Male: yes
150Phase 3United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden
282ChiCTR-IPR-16009395
2016-11-012016-10-14Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stageClinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage Parkinson’s diseaseButylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks;Control:No treatment;The Second Affiliated Hospital of Soochow UniversityNULLPending35BothButylphthalide group and Control group:36;Control:36;China
283NCT03022799
(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
284EUCTR2015-001786-10-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]
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot Recruiting Female: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
285EUCTR2016-000657-12-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2United States;Portugal;Taiwan;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT02847650
(ClinicalTrials.gov)
October 17, 201625/7/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the 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 DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751PfizerNULLTerminated45 Years80 YearsAll57Phase 2United States;France;Germany;Israel
287EUCTR2015-002571-24-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]Joint Research OfficeNULLNot Recruiting Female: yes
Male: yes
20Phase 2United Kingdom
288NCT02728843
(ClinicalTrials.gov)
October 12, 201631/3/2016Study of Parkinson's Early Stage With DeferiproneA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone;Drug: PlaceboApoPharmaNULLCompleted18 Years80 YearsAll140Phase 2Canada;France;Germany;United Kingdom
289EUCTR2016-002391-27-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 specifyBIAL - Portela & Ca, S.A.NULLNot Recruiting Female: yes
Male: yes
550Phase 4Germany;United Kingdom
290NCT02538315
(ClinicalTrials.gov)
October 201625/8/2015Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsUsing 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsParkinson`s DiseaseDrug: [18F]FDOPA PET/CTUniversity of SaskatchewanUniversity of ManitobaRecruiting18 YearsN/AAll30N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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
293EUCTR2015-005814-31-AT
(EUCTR)
29/08/201611/05/2016-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 finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
294NCT02782481
(ClinicalTrials.gov)
August 201622/5/2016A 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 FluctuationsParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLWithdrawn30 Years80 YearsAll0Phase 3Israel
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296NCT02789592
(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
297EUCTR2015-004344-19-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]
ApoPharma Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2United States;France;Canada;Germany;Italy;United Kingdom
298EUCTR2015-005626-19-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
299EUCTR2015-003512-20-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
300EUCTR2015-004912-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2015-005626-19-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
302EUCTR2015-003512-20-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
303NCT02807675
(ClinicalTrials.gov)
June 201617/6/2016A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301, LIP;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll36Phase 1United States
304EUCTR2016-000679-25-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]INSTITUT DE RECERCA HSCSPNULLNot Recruiting Female: yes
Male: yes
56Phase 2Spain
305JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2015-005078-39-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
307EUCTR2015-003512-20-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
308EUCTR2016-000636-18-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]
Sunuvion Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
126Phase 3United States;Canada;United Kingdom
309EUCTR2016-000637-43-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
310JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311JPRN-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
312EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical 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: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
313NCT02726386
(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
314NCT02784145
(ClinicalTrials.gov)
May 201617/5/2016Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseEffects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseParkinson DiseaseDietary Supplement: Resistant starch;Other: Recommendation with regard to nutritionSaarland UniversityNULLCompleted18 YearsN/AAll95N/AGermany
315EUCTR2015-003512-20-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]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2015-004507-23-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
317EUCTR2015-003512-20-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]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
318EUCTR2014-005630-60-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
319NCT02764125
(ClinicalTrials.gov)
April 8, 201613/1/2016Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-offParkinson's DiseaseDrug: Stalevo;Drug: levodopa MROrion Corporation, Orion PharmaNULLCompleted30 YearsN/AAll84Phase 2Finland;Germany;Hungary;Latvia
320EUCTR2015-005067-17-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
345Phase 3United States;Czech Republic;Canada;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321NCT02719496
(ClinicalTrials.gov)
April 201615/3/2016Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseProve of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseGastrointestinal Disorders in Parkinson's DiseaseDrug: IBEROGASTNantes University HospitalNULLCompleted30 Years80 YearsAll45Phase 2France
322NCT02775591
(ClinicalTrials.gov)
April 20169/5/2016Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal SymptomsEffect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled TrialParkinson Disease;DyspepsiaDrug: DA-9701;Drug: DA-9701 placeboSeoul National University HospitalSamsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical CenterCompleted50 Years80 YearsAll147Phase 4Korea, Republic of
323EUCTR2015-004344-19-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
324NCT02462603
(ClinicalTrials.gov)
March 31, 201620/5/2015Safety and Biomarker Study of EPI-589 in Parkinson's DiseaseA Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease SubjectsParkinson's DiseaseDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years75 YearsAll44Phase 2United States;Germany;United Kingdom
325EUCTR2015-004507-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326EUCTR2015-005067-17-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
327NCT02687542
(ClinicalTrials.gov)
March 3, 201629/1/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD)PfizerNULLTerminated40 Years85 YearsAll108Phase 2United States;Canada;France;Germany;Japan;Spain
328NCT02605434
(ClinicalTrials.gov)
March 20165/11/2015A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's PatientsPhase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's PatientsParkinson's DiseaseDrug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- SinemetIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll420Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary
329NCT04569656
(ClinicalTrials.gov)
February 2, 201624/9/2020Treatment of Chronic Constipation in Parkinson's DiseasePilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's DiseaseParkinson DiseaseDrug: hydrolyzed guar gumIRCCS San RaffaeleNULLCompleted18 YearsN/AAll34Phase 2Italy
330NCT02618941
(ClinicalTrials.gov)
February 2, 201625/11/2015Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 ProgramParkinson's DiseaseBiological: AFFITOPE® PD01AAffiris AGNULLCompleted40 Years68 YearsAll26Phase 1Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT02683629
(ClinicalTrials.gov)
February 20168/2/2016Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseA Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NTCELL Implantation;Other: Sham SurgeryLiving Cell TechnologiesStatistecol Consultants LimitedCompleted40 Years65 YearsAll18Phase 2New Zealand
332EUCTR2015-001786-10-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
333NCT02649608
(ClinicalTrials.gov)
January 20166/1/2016An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease PatientsInterventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's DiseaseParkinson DiseaseDrug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621;Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621H. Lundbeck A/SNULLCompleted45 Years75 YearsAll15Phase 1United States
334NCT02579473
(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
335NCT02639221
(ClinicalTrials.gov)
January 201617/12/2015A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female SubjectsPXT002331 A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female SubjectsParkinson's DiseaseDrug: PXT002331Prexton TherapeuticsNULLCompleted18 Years60 YearsBoth64Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2014-002600-24-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
337JPRN-JapicCTI-153057
14/12/201502/11/2015ME2125 Phase III (ME2125-4)A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon Parkinson's diseaseIntervention name : ME2125 (safinamide mesilate)
INN of the intervention : safinamide
Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.
Meiji Seika Pharma Co., Ltd.NULLcomplete30BOTH200Phase 3Japan
338EUCTR2014-005630-60-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Germany
339EUCTR2014-002600-24-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
340EUCTR2014-002600-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341NCT02616120
(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
342JPRN-JapicCTI-153056
24/11/201502/11/2015ME2125 Phase II/III (ME2125-3)A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon Parkinson's diseaseIntervention name : ME2125 (safinamide mesilate)
INN of the intervention : safinamide
Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.
Meiji Seika Pharma Co., Ltd.NULLcomplete30BOTH410Phase 2;Phase 3Japan
343EUCTR2015-002631-17-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]Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLNot Recruiting Female: yes
Male: yes
18Phase 4Spain
344EUCTR2014-002600-24-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
345NCT02565628
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2014-002600-24-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
347NCT02758730
(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
348NCT02577523
(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
349EUCTR2014-005630-60-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
350NCT02572713
(ClinicalTrials.gov)
October 20157/10/2015Systemic Synuclein Sampling Study (S4)Systemic Synuclein Sampling Study (S4)Parkinson's DiseaseProcedure: Biofluid samplings;Procedure: Tissue samplings;Drug: DaTSCAN™Michael J. Fox Foundation for Parkinson's ResearchIndiana University;University of Iowa;Banner Health;Paracelsus Elena KlinikCompleted40 YearsN/AAll80N/AUnited States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02562768
(ClinicalTrials.gov)
September 30, 201528/9/2015A Study of LY3154207 in Healthy Participants and Participants With Parkinson's DiseaseMultiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted20 YearsN/AAll80Phase 1United States
352EUCTR2014-005630-60-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
353NCT02542696
(ClinicalTrials.gov)
August 31, 20153/9/2015Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseAn Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277SunovionNULLRecruiting18 YearsN/AAll226Phase 3United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom
354EUCTR2015-000373-13-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
355NCT02337751
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT02488265
(ClinicalTrials.gov)
July 1, 201521/5/2015Protocol: Balance Training in Parkinson's DiseaseRandomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's DiseaseParkinson DiseaseOther: Balance Training;Other: Screening to prevent fallsUniversity of Sao Paulo General HospitalNULLCompleted50 Years70 YearsAll150N/ABrazil
357NCT02459886
(ClinicalTrials.gov)
July 1, 201529/5/2015Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's DiseaseA Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's DiseaseParkinson's Disease;HealthyDrug: BIIB054;Drug: PlaceboBiogenNULLCompleted40 Years80 YearsAll66Phase 1United States
358NCT02453386
(ClinicalTrials.gov)
July 201521/5/2015Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)Idiopathic Parkinson's DiseaseDrug: tozadenant;Drug: placeboBiotie Therapies Inc.NULLTerminated30 Years80 YearsAll449Phase 3United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic
359NCT02415062
(ClinicalTrials.gov)
July 201514/3/2015The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With DementiaThe Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With DementiaParkinson's DiseaseDrug: DonepezilInje UniversityNULLRecruiting50 Years80 YearsBoth150Phase 2Korea, Republic of
360EUCTR2014-003738-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2014-003739-20-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
362NCT02469090
(ClinicalTrials.gov)
June 18, 20159/6/2015Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson Disease, Off EpisodesDrug: APL-130277;Drug: PlaceboSunovionNULLCompleted18 YearsN/AAll141Phase 3United States;Canada;United Kingdom
363NCT02769793
(ClinicalTrials.gov)
June 20159/5/2016Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ONEfficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over TrialParkinson DiseaseDrug: Levodopa dispersible;Drug: LevodopaSeoul National University HospitalSMG-SNU Boramae Medical Center;Samsung Medical CenterUnknown status31 Years80 YearsAll40Phase 4Korea, Republic of
364EUCTR2014-003799-22-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
365EUCTR2010-024424-26-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]
AB ScienceNULLNot Recruiting Female: yes
Male: yes
45Phase 2France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT02439125
(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
367NCT02439203
(ClinicalTrials.gov)
May 201530/4/2015Efficacy and Safety of JM-010 in PD With Levodopa-Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010Parkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: JM-010;Drug: PlaceboBukwang PharmaceuticalContera Pharma ApSCompleted18 YearsN/ABoth30Phase 2South Africa
368EUCTR2014-003738-24-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
369EUCTR2014-003739-20-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]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
250Phase 3France;United States;Spain;Austria;Germany
370EUCTR2014-003799-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371EUCTR2014-003739-20-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]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
200Phase 3United States;France;Spain;Austria;Germany
372EUCTR2014-003739-20-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
373EUCTR2014-003738-24-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
374EUCTR2014-003799-22-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
375NCT02242487
(ClinicalTrials.gov)
March 201515/9/2014Twelve Month Safety and Efficacy Study of 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)Idiopathic Parkinson's DiseaseDrug: CVT-301Acorda TherapeuticsNULLCompleted30 Years86 YearsAll325Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT02696603
(ClinicalTrials.gov)
March 201523/2/2016Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Parkinson Disease;Neurodegenerative Diseases;Movement Disorders;Central Nervous System Diseases;Brain Diseases;Basal Ganglia Diseases;Parkinsonian DisordersBehavioral: Participant self-assessment surveys;Behavioral: Phonation;Behavioral: Gait and balance;Behavioral: Memory;Behavioral: Dexterity;Behavioral: Participant open-response writing;Other: Parkinson mPower mobile applicationSage BionetworksRobert Wood Johnson FoundationRecruiting18 YearsN/AAll20000N/AUnited States
377NCT02066571
(ClinicalTrials.gov)
March 201518/2/2014Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's DiseaseA Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's DiseaseParkinson's Disease;Freezing of Gait;Cognitive Ability, GeneralDrug: Droxidopa;Drug: sugar pillHenry Ford Health SystemNULLEnrolling by invitation30 YearsN/ABoth20Phase 2United States
378NCT02352363
(ClinicalTrials.gov)
March 201526/1/2015Randomized Safety Study of CVT-301 Compared to an Observational Control GroupA Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort ControlIdiopathic Parkinson's DiseaseDrug: CVT-301;Other: Observational cohortAcorda TherapeuticsNULLCompleted30 Years85 YearsAll408Phase 3United States;Austria;Belgium;Czechia;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Serbia;Spain;United Kingdom;Czech Republic;Italy
379NCT02373072
(ClinicalTrials.gov)
March 201520/2/2015A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's DiseaseA Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: PF-06649751;Drug: Trimethobenzamide Hydrochloride;Drug: PlaceboPfizerNULLCompletedN/AN/AAll18Phase 1United States;Belgium
380EUCTR2014-003799-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381EUCTR2014-003799-22-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
382NCT02337725
(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
383NCT02337764
(ClinicalTrials.gov)
February 3, 20159/1/2015A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease PatientsParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll222Phase 3Japan
384EUCTR2014-003799-22-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
385NCT02339064
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386NCT02337738
(ClinicalTrials.gov)
January 27, 20159/1/2015A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing OffParkinson's DiseaseDrug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: PlaceboTakedaNULLCompleted30 Years79 YearsAll404Phase 2;Phase 3Japan
387JPRN-JapicCTI-152762
27/1/2015A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease PatientsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients Parkinson's diseaseIntervention name : TVP-1012 (1 mg/day) with levodopa
Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period.
Control intervention name : null
TAKEDA PHARMACEUTICAL COMPANY LTD.NULL3079BOTH215Phase 3NULL
388EUCTR2014-003799-22-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]
Civitas Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
365Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
389NCT02347059
(ClinicalTrials.gov)
January 201520/1/2015L-dopa Versus Dopamine Agonists After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's DiseaseA Randomized, Single-blind Trial on the Efficacy and Safety of L-dopa Monotherapy Versus Dopamine Agonists Monotherapy After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's DiseaseParkinson's DiseaseDrug: L-dopa;Drug: Dopamine Agonists (pramipexole, ropirinole)University of TorontoMichael J. Fox Foundation for Parkinson's ResearchRecruitingN/AN/ABoth40Phase 2Canada
390NCT02763137
(ClinicalTrials.gov)
January 201526/4/2016Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian PatientsA 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 FluctuationsParkinson DiseaseDrug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CDIRCCS San RaffaeleSynAgile CorporationCompleted35 Years75 YearsBoth18Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391NCT02258152
(ClinicalTrials.gov)
December 22, 20143/10/2014SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)Parkinson's Disease Dementia (PDD)Drug: SYN120;Drug: PlaceboBiotie Therapies Inc.Michael J. Fox Foundation for Parkinson's Research;Massachusetts General Hospital;Acorda TherapeuticsCompleted50 YearsN/AAll82Phase 2United States
392NCT02267434
(ClinicalTrials.gov)
December 20144/9/2014Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's DiseaseA Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesBiological: Low dose AFFITOPE® PD03A + Adjuvant;Biological: High dose AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active componentAffiris AGPROSENEX AmbulatoriumbetriebsGMBH;Medical University Innsbruck;Forschungszentrum JuelichCompleted45 Years70 YearsBoth36Phase 1Austria
393EUCTR2014-001132-10-FR
(EUCTR)
18/11/201418/06/2015A 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: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162United States;France;Canada;Spain;Germany
394NCT02240030
(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
395EUCTR2014-001132-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396EUCTR2014-001131-36-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
397EUCTR2014-002295-87-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
398NCT02224664
(ClinicalTrials.gov)
October 201415/8/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s DiseaseA Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor FluctuationsParkinson`s DiseaseDrug: PF-06649751PfizerNULLCompleted30 Years80 YearsAll50Phase 1United States;Belgium
399NCT02274766
(ClinicalTrials.gov)
October 201422/10/2014Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced DyskinesiaADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll77Phase 3United States;Austria;France;Germany;Spain
400NCT02225548
(ClinicalTrials.gov)
September 201422/8/2014Sagene 2014 - Parkinson's Disease and Erectile DysfunctionAn Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction.Parkinson's Disease;Erectile DysfunctionDrug: Selegiline;Drug: TadalafilUniversity of South FloridaNULLRecruiting40 Years64 YearsMale10Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401NCT03151460
(ClinicalTrials.gov)
September 20149/5/2017Dopaminergic Modulation of Declarative MemoryDopaminergic Modulation of Declarative MemoryParkinson's DiseaseDrug: Dopamine AgentI.R.C.C.S. Fondazione Santa LuciaNULLCompletedN/AN/AAll40Phase 4Italy
402NCT02228590
(ClinicalTrials.gov)
August 31, 201426/8/2014A Study to Examine APL-130277 in Patients With Parkinson's DiseaseA Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: APL-130277SunovionNULLCompleted18 Years80 YearsAll20Phase 2United States
403NCT02153645
(ClinicalTrials.gov)
August 18, 201430/5/2014Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesias (LID)Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tabletsOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll87Phase 3United States;Canada;France;Germany;Spain
404NCT02216188
(ClinicalTrials.gov)
August 201412/8/2014Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical ActivityPhase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008Parkinson's DiseaseBiological: AFFITOPE® PD01A;Other: ControlAffiris AGNULLCompleted40 Years68 YearsBoth28Phase 1Austria
405NCT02153632
(ClinicalTrials.gov)
July 30, 201430/5/2014Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LIDA 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 DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: amantadine HCl ER;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll135Phase 3United States;Canada;France;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406NCT02202551
(ClinicalTrials.gov)
July 201425/7/2014Open-Label Safety Study of ADS-5102 in PD Patients With LIDOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll223Phase 3United States;Austria;Canada;France;Germany;Spain
407EUCTR2013-000980-10-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
408NCT02136914
(ClinicalTrials.gov)
May 20149/5/2014ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's DiseaseDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll126Phase 3United States;Canada
409EUCTR2012-005539-10-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
410EUCTR2013-002254-70-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411NCT03314597
(ClinicalTrials.gov)
April 2, 201415/10/2017Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.Parkinson's Disease;RehabilitationOther: Balance exercise;Other: Mobile platform exerciseUniversity of PaviaFondazione Salvatore MaugeriCompleted50 Years85 YearsAll38N/ANULL
412NCT02091739
(ClinicalTrials.gov)
April 201418/3/2014Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsProspective, 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 ConditionsChronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain InjuryDrug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: PlaceboMerz Pharmaceuticals GmbHNULLCompleted18 Years80 YearsAll184Phase 3Germany;Poland;United States
413NCT02741947
(ClinicalTrials.gov)
April 201431/3/2016Levodopa Benserazide Generic Formulation Versus the OriginatorClinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)Parkinson DiseaseDrug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva ItaliaIRCCS San RaffaeleAgenzia Italiana del FarmacoCompleted30 Years75 YearsBoth44Phase 4Italy
414NCT02082249
(ClinicalTrials.gov)
March 10, 201414/2/2014An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLCompleted30 Years99 YearsAll23Phase 3Japan;Korea, Republic of;Taiwan
415EUCTR2013-002254-70-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416NCT02006121
(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
417EUCTR2013-000980-10-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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
418NCT02006290
(ClinicalTrials.gov)
March 20145/12/2013Efficacy, Safety And Tolerability Study In Subjects With Parkinson's DiseaseA Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: PF-06412562;Drug: PlaceboPfizerNULLCompleted30 Years75 YearsBoth19Phase 1United States
419NCT02111330
(ClinicalTrials.gov)
March 201420/3/2014Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy VolunteersRandomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy VolunteersParkinson DiseaseDrug: PBF-509;Drug: PlaceboFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPalo Biofarma, S.LCompleted18 Years45 YearsBoth16Phase 1Spain
420EUCTR2013-002254-70-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421EUCTR2013-002254-70-IT
(EUCTR)
21/02/201427/11/2013Study 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: 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
422EUCTR2013-000980-10-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
423EUCTR2013-000980-10-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
424EUCTR2013-002545-10-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
425NCT02018406
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426NCT01883505
(ClinicalTrials.gov)
December 20139/6/2013A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612Parkinson's DiseaseDrug: Levodopa and carbidopa;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth30Phase 2Israel
427NCT01968460
(ClinicalTrials.gov)
December 201315/10/2013Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseA Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseParkinson's DiseaseDrug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Pharma Two B Ltd.NULLCompleted35 Years75 YearsAll149Phase 2;Phase 3United States;Israel
428NCT04044547
(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
429EUCTR2013-000980-10-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
430NCT01973543
(ClinicalTrials.gov)
October 201325/10/2013Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to LevodopaParkinson's DiseaseBiological: VY-AADC01Neurocrine BiosciencesUniversity of California, San Francisco;Veristat, Inc.;Feinstein Institute for Medical Research;Oregon Health and Science University;Voyager TherapeuticsCompleted40 Years70 YearsAll15Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT01960842
(ClinicalTrials.gov)
October 20139/10/2013A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVieNULLCompleted30 YearsN/AAll31Phase 3Japan;Korea, Republic of;Taiwan
432NCT02055274
(ClinicalTrials.gov)
October 201331/1/2014Pharmacokinetics and Safety 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's DiseaseDrug: LY03003;Drug: NeuproLuye Pharma Group Ltd.NULLCompleted18 YearsN/ABoth39Phase 1United States
433EUCTR2013-001881-40-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]
North Bristol NHS Trust (NBT)NULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
434NCT01955616
(ClinicalTrials.gov)
September 201325/9/2013A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic ConstipationA Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current TherapyParkinson's DiseaseDrug: RM-131;Drug: PlaceboMotus Therapeutics, Inc.Michael J. Fox Foundation for Parkinson's ResearchTerminated18 Years80 YearsBoth18Phase 2United States
435NCT01882010
(ClinicalTrials.gov)
September 201313/6/2013Leukine (Sargramostim) for Parkinson's DiseaseLeukine (Sargramostim) for Parkinson's DiseaseParkinson's DiseaseProcedure: blood draw;Procedure: physical exam and UPDRS part III assessment;Procedure: MEG;Drug: sargramostim;Drug: placebo;Behavioral: physical exam and UPDRS part III assessment;Procedure: Motion AnalysisHoward Gendelman, MDSanofi;National Institute of Neurological Disorders and Stroke (NINDS);UNeMed;Nebraska Neuroscience AllianceCompleted35 Years85 YearsBoth37Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436NCT01767129
(ClinicalTrials.gov)
July 20139/1/2013Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease PatientsA Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients.Dyskinesia;Parkinson's DiseaseDrug: AVP-923-45;Drug: PlaceboAvanir PharmaceuticalsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll14Phase 2United States;Canada
437NCT01765257
(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
438NCT01879748
(ClinicalTrials.gov)
June 201313/6/2013A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of RasagilineA Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian SubjectsParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Pharmaceutical IndustriesNULLCompleted20 Years50 YearsBoth64Phase 1United States
439NCT02263235
(ClinicalTrials.gov)
June 201318/9/2014In Vivo Alzheimer ProteomicsUse of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer DiseaseProbable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute HydrocephalyBiological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, salivaUniversity Hospital, MontpellierAssistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy AgencyRecruiting55 Years85 YearsBoth110N/AFrance
440JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441EUCTR2012-005822-31-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 2bUnited States;Serbia;United Kingdom;Italy
442NCT02500108
(ClinicalTrials.gov)
May 201314/7/2015Domperidone and Risk of Sudden Cardiac DeathDomperidone Use in Parkinson's Disease and Risk of Sudden Cardiac DeathParkinson's DiseaseDrug: DomperidoneCanadian Network for Observational Drug Effect Studies, CNODESDrug Safety and Effectiveness Network, Canada;Canadian Institutes of Health Research (CIHR)Completed50 YearsN/ABoth214962N/ACanada
443NCT01860794
(ClinicalTrials.gov)
May 201314/5/2013Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's DiseaseInvestigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's DiseaseIdiopathic Parkinson Disease;Primary ParkinsonismDrug: Mesencephalic Neuronal Precursor CellsBundang CHA HospitalNULLRecruiting18 Years70 YearsFemale15Phase 1;Phase 2Korea, Republic of
444NCT03022201
(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
445EUCTR2012-005822-31-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 2bUnited States;Serbia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446NCT01777555
(ClinicalTrials.gov)
April 201323/1/2013Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF EpisodesA 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)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: PlaceboAcorda TherapeuticsNULLCompleted30 Years80 YearsAll89Phase 2United States;Italy;Serbia;United Kingdom
447NCT01829867
(ClinicalTrials.gov)
April 20139/4/2013A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular InfusionParkinson's DiseaseDrug: sNN0031Newron Sweden ABNULLTerminated55 Years75 YearsBoth5Phase 1Sweden
448NCT01736176
(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
449JPRN-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
450NCT01803945
(ClinicalTrials.gov)
January 201326/2/2013A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's DiseaseA Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: AVE8112;Drug: PlaceboMichael J. Fox Foundation for Parkinson's ResearchSanofiTerminated35 Years70 YearsBoth32Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT01770145
(ClinicalTrials.gov)
December 20127/1/2013Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa ActionParkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa OnsetDrug: APOKYN;Drug: L-dopa;Drug: TrimethobenzamideUS WorldMeds LLCNULLCompleted18 YearsN/AAll127Phase 4United States
452NCT01725802
(ClinicalTrials.gov)
December 20124/11/2012A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsA Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsParkinson's DiseaseDrug: levodopa and carbidopa solution for SC administration;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth8Phase 1;Phase 2Israel
453NCT01683253
(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 4NULL
454NCT03652363
(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
455JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT01603069
(ClinicalTrials.gov)
October 201214/5/2012A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseA Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: PlaceboAstraZenecaNULLCompleted30 Years80 YearsBoth51Phase 2United States
457NCT01723904
(ClinicalTrials.gov)
October 20126/11/2012A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's DiseaseAn Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3BAdvanced Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll90Phase 3Australia;Korea, Republic of;Malaysia;Singapore;Taiwan
458NCT01691924
(ClinicalTrials.gov)
October 201213/9/2012Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy VolunteersRandomized, Double Blind, Placebo Controlled First In-human Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy VolunteersParkinson DiseaseDrug: PBF-509;Drug: PlaceboFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPalo Biofarma, S.LCompleted18 Years45 YearsMale56Phase 1Spain
459EUCTR2011-003866-34-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]
North Bristol NHS Trust (NBT)NULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
460EUCTR2011-004378-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT00947037
(ClinicalTrials.gov)
August 201224/7/2009Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension StudyAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease SubjectsParkinson's DiseaseDrug: AP-CD/LDIntec Pharma Ltd.NULLWithdrawn30 Years95 YearsBoth0Phase 2Israel
462NCT02419313
(ClinicalTrials.gov)
August 201227/1/2014Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized ApproachInvestigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized ApproachParkinson;TremorDrug: incobotulinumtoxinA;Drug: SalineYale UniversityNULLCompleted18 YearsN/AAll33Phase 2United States
463JPRN-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
464NCT01398748
(ClinicalTrials.gov)
July 201219/7/2011Intranasal Glutathione in Parkinson's DiseaseA Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's DiseaseParkinson's Disease (PD)Drug: Intranasal glutathione - (in)GSH;Drug: Saline Intranasal DeliveryBastyr UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed21 Years100 YearsAll34Phase 1United States
465NCT01646255
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466NCT01646268
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease PatientsA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's DiseaseIDIOPATHIC PARKINSON'S DISEASEDrug: Rotigotine;Drug: Placebo PatchUCB PharmaNULLCompleted30 YearsN/AAll249Phase 3China
467EUCTR2011-002074-23-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
468EUCTR2012-001218-40-IT
(EUCTR)
21/05/201223/07/2012EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTSEFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
MedDRA version: 14.1;Level: PT;Classification code 10056242;Term: Parkinsonian gait;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: NEUPRO*7CER 4MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*7CER 6MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*7CER 8MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 2MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 4MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 6MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 8MG/24H
INN or Proposed INN: rotigotina
FONDAZIONE SANTA LUCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
469EUCTR2011-004378-27-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
470EUCTR2011-004378-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT01617135
(ClinicalTrials.gov)
May 20127/5/2012Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off EpisodesA Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa)Acorda TherapeuticsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll25Phase 2Israel;Serbia;United Kingdom
472EUCTR2012-000181-37-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
473NCT01491529
(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
474NCT01331122
(ClinicalTrials.gov)
April 201213/10/2010Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's DiseaseA Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's DiseaseGait Disorders, NeurologicDrug: droxidopaChelsea TherapeuticsNULLWithdrawn30 YearsN/ABoth0Phase 1;Phase 2United States;Canada
475NCT01486628
(ClinicalTrials.gov)
April 20124/12/2011Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersA Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLCompleted18 Years40 YearsMale36Phase 1Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476NCT01550484
(ClinicalTrials.gov)
April 20126/3/2012A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement DisordersAn Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain DiagnosisParkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's DiseaseDrug: 18F-AV-133Avid RadiopharmaceuticalsNULLCompleted40 YearsN/AAll170Phase 2;Phase 3United States;Australia
477EUCTR2011-002074-23-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