Pridopidine ( DrugBank: Pridopidine )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
6パーキンソン病1
8ハンチントン病24

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04615923
(ClinicalTrials.gov)
December 18, 202029/10/2020HEALEY ALS Platform Trial - Regimen D PridopidineHEALEY ALS Platform Trial - Regimen D PridopidineAmyotrophic Lateral SclerosisDrug: Pridopidine;Drug: Matching PlaceboMerit E. Cudkowicz, MDPrilenia TherapeuticsActive, not recruiting18 YearsN/AAll163Phase 2/Phase 3United States
2NCT04297683
(ClinicalTrials.gov)
July 14, 20203/3/2020HEALEY ALS Platform Trial - Master ProtocolHEALEY ALS Platform TrialAmyotrophic Lateral SclerosisDrug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8;Drug: Pridopidine;Drug: SLS-005 TrehaloseMerit E. Cudkowicz, MDMassachusetts General HospitalRecruiting18 YearsN/AAll800Phase 2/Phase 3United States

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03922711
(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

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002822-10-NL
(EUCTR)
26/02/202124/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3Austria;Czech Republic;Germany;Netherlands
2EUCTR2020-002822-10-CZ
(EUCTR)
21/01/202110/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;Italy;United Kingdom
3EUCTR2020-002822-10-AT
(EUCTR)
18/01/202109/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;United Kingdom
4EUCTR2020-002822-10-DE
(EUCTR)
11/12/202006/11/2020A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: PL101
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Other descriptive name: Pridiopidine
Prilenia Neurotherapeutics Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;Italy;United Kingdom
5EUCTR2020-002822-10-IT
(EUCTR)
23/11/202024/05/2021A study of Pridopidine in Patients with Early Stage of Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients with Early Stage of Huntington Disease - PRidopidine Outcome on Function in Huntington Disease (PROOF-HD) Huntington Disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: [PL101]
INN or Proposed INN: PRIDOPIDINE HYDROCHLORIDE
Prilenia Neurotherapeutics LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;Czech Republic;European Union;Canada;Austria;Netherlands;Germany;United Kingdom;Italy
6NCT04556656
(ClinicalTrials.gov)
October 16, 202014/9/2020PRidopidine's Outcome On Function in Huntington Disease, PROOF- HDA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington DiseaseHuntington DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLActive, not recruiting25 YearsN/AAll499Phase 3United States;Austria;Canada;Czechia;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
7NCT03019289
(ClinicalTrials.gov)
April 19, 20173/1/2017A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's DiseaseA Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's DiseaseHealth Volunteers, Huntington DiseaseDrug: pridopidine (90 mg)PrileniaNULLCompleted25 YearsN/AMale23Phase 1Germany
8EUCTR2015-000904-24-NL
(EUCTR)
15/02/201617/02/2016A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Canada;Poland;Denmark;Austria;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom
9EUCTR2015-000904-24-DE
(EUCTR)
03/12/201504/08/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Poland;Austria;Australia;France;United States;Canada;Russian Federation;Netherlands;Germany;Italy;United Kingdom
10EUCTR2015-000904-24-AT
(EUCTR)
18/11/201515/09/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 19.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Canada;Poland;Denmark;Australia;Austria;Russian Federation;Netherlands;Germany;Italy;United Kingdom
11EUCTR2015-000904-24-GB
(EUCTR)
13/11/201518/08/2015A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Poland;Austria;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom
12NCT02494778
(ClinicalTrials.gov)
September 24, 20157/7/2015A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)Huntington's DiseaseDrug: PridopidinePrileniaNULLTerminated21 YearsN/AAll248Phase 2United States;Australia;Austria;Canada;France;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom;Denmark
13EUCTR2015-000904-24-IT
(EUCTR)
15/09/201523/02/2018A study testing if pridopidine is safe and efficacious in patients with Huntington's DiseaseA Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington's Disease - Open PRIDE-HD Huntington's disease
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidina
Product Code: TV-7820
INN or Proposed INN: Pridopidina
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidina
Product Code: TV-7820
INN or Proposed INN: Pridopidina
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INCNULLNot RecruitingFemale: yes
Male: yes
400Phase 2France;United States;Canada;Poland;Denmark;Austria;Australia;Russian Federation;Netherlands;Germany;United Kingdom;Italy
14EUCTR2013-001888-23-DK
(EUCTR)
13/04/201508/01/2015A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 17.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Denmark;Australia;Germany;Netherlands
15EUCTR2013-001888-23-PL
(EUCTR)
23/07/201414/05/2014A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
16EUCTR2013-001888-23-AT
(EUCTR)
01/07/201408/01/2014A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
17EUCTR2013-001888-23-NL
(EUCTR)
07/04/201420/12/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Netherlands;Germany
18EUCTR2013-001888-23-DE
(EUCTR)
25/03/201410/12/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
19EUCTR2013-001888-23-IT
(EUCTR)
13/03/201411/12/2013A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 14.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Netherlands;United States;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany
20NCT02006472
(ClinicalTrials.gov)
February 28, 20145/12/2013A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's DiseaseA Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's DiseaseHuntington's DiseaseDrug: Pridopidine;Other: PlaceboPrileniaEuropean Huntington's Disease Network;Huntington Study GroupCompleted21 YearsN/AAll408Phase 2United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom
21EUCTR2013-001888-23-GB
(EUCTR)
22/01/201427/11/2013A study testing different doses of pridopidine (45 mg, 67.5 mg, 90 mg, 112.5 mg twice-daily) against placebo to establish which one works best and is safe when treating certain symptoms of patients with Huntington´s Disease.A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease Huntington’s disease
MedDRA version: 17.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Product Name: Pridopidine
Product Code: TV-7820
INN or Proposed INN: pridopidine
Other descriptive name: ACR16 hydrochloride, ASP2314 hydrochloride, FR310826
Teva Branded Pharmaceutical Products R&D, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 2United States;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Australia;Denmark;Germany;Netherlands
22NCT01306929
(ClinicalTrials.gov)
March 1, 201128/2/2011Open-label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington DiseaseA Multi-Center, North American, Open-Label Extension Study of Pridopidine (ACR16) in the Symptomatic Treatment of Huntington's Disease (Open-HART).Huntington DiseaseDrug: pridopidinePrileniaNULLCompletedN/AN/AAll235Phase 2United States;Canada
23NCT00724048
(ClinicalTrials.gov)
October 200824/7/2008A Study of Pridopidine (ACR16) for the Treatment of Patients With Huntington's DiseaseA Multi-center, North American, Randomized, Double-blind, Parallel Group Study Comparing Three Doses of ACR16 Versus Placebo for the Symptomatic Treatment of Huntington Disease (HART)Huntington DiseaseDrug: ACR16 10 mg;Drug: ACR16 22.5 mg;Drug: ACR16 45 mg;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth227Phase 2/Phase 3United States;Canada
24NCT00665223
(ClinicalTrials.gov)
April 200822/4/2008A Study of Treatment With Pridopidine (ACR16) in Patients With Huntington's DiseaseA Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's DiseaseHuntington's DiseaseDrug: ACR16;Drug: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth437Phase 3Austria;Belgium;France;Germany;Italy;Portugal;Spain;United Kingdom