ACR16 hydrochloride, ASP2314 hydrochloride, FR310826 ( DrugBank: ACR-16 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病12

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
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size
PhaseCountries
1EUCTR2015-000904-24-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
2EUCTR2015-000904-24-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
3EUCTR2015-000904-24-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
4EUCTR2015-000904-24-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
5EUCTR2015-000904-24-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
6EUCTR2013-001888-23-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
7EUCTR2013-001888-23-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
8EUCTR2013-001888-23-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
9EUCTR2013-001888-23-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
10EUCTR2013-001888-23-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
11EUCTR2013-001888-23-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
12EUCTR2013-001888-23-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