Dexpramipexole ( DrugBank: Dexpramipexole )


1 disease
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21

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
1EUCTR2011-006119-70-DE
(EUCTR)
31/08/201220/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
2EUCTR2011-006119-70-NL
(EUCTR)
30/08/201214/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
3EUCTR2011-006119-70-BE
(EUCTR)
13/08/201214/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850Phase 3United States;Canada;Spain;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
4EUCTR2011-006119-70-GB
(EUCTR)
10/08/201218/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
5EUCTR2011-006119-70-IE
(EUCTR)
03/08/201207/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
6EUCTR2011-006119-70-ES
(EUCTR)
27/07/201211/06/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
7NCT01622088
(ClinicalTrials.gov)
June 20123/5/2012Phase 3 Extension Study of Dexpramipexole in ALSAn Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: DexpramipexoleKnopp BiosciencesBiogenTerminated18 Years80 YearsAll616Phase 3United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom
8EUCTR2011-006119-70-SE
(EUCTR)
15/05/201219/04/2012Clinical Extension Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis - ENVISION Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050/KNS-760704
Other descriptive name: Dexpramipexole
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
850United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
9NCT01536249
(ClinicalTrials.gov)
March 201216/2/2012Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Cimetidine plus DexpramipexoleKnopp BiosciencesNULLCompleted18 Years55 YearsBoth14Phase 1United States
10NCT01511029
(ClinicalTrials.gov)
January 20129/1/2012Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Dexpramipexole Placebo;Drug: MoxifloxacinKnopp BiosciencesNULLCompleted18 Years60 YearsBoth68Phase 1United States
11NCT01449578
(ClinicalTrials.gov)
November 201122/9/2011Dexpramipexole SAD/MAD StudyA Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy VolunteersAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: Dexpramipexole PlaceboKnopp BiosciencesNULLCompleted18 Years55 YearsBoth63Phase 1United States
12NCT01424163
(ClinicalTrials.gov)
August 201128/7/2011Dexpramipexole Japanese PK StudyA Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian SubjectsAmyotrophic Lateral SclerosisDrug: Single dose reduced;Drug: Single dose standard;Drug: Multiple DoseKnopp BiosciencesBiogenCompleted18 Years60 YearsAll57Phase 1United Kingdom
13NCT01424176
(ClinicalTrials.gov)
July 201123/6/2011Dexpramipexole Renal PK StudyA Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal ImpairmentAmyotrophic Lateral Sclerosis;Renal InsufficiencyDrug: Dexpramipexole (dose 1);Drug: Dexpramipexole (dose 2)Knopp BiosciencesNULLCompleted18 Years75 YearsBoth36Phase 1United States
14EUCTR2010-022818-19-ES
(EUCTR)
09/06/201121/02/2011A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWERA randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de la seguridad y eficacia de Dexpramipexol en sujetos con Esclerosis Lateral Amiotrófica - EMPOWER Amyotrophic lateral sclerosis (ALS)Esclerosis lateral amiotrófica (ELA)
MedDRA version: 12.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: (6R)-4, 5, 6, 7 - tetrahydro-N6-propyl-2,6-benzothiazolidiamine dihydrochloride monohydrate
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
804Phase 3Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Sweden
15EUCTR2010-022818-19-BE
(EUCTR)
07/06/201124/01/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915Phase 3United States;Canada;Spain;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
16EUCTR2010-022818-19-NL
(EUCTR)
24/05/201111/05/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden
17EUCTR2010-022818-19-DE
(EUCTR)
12/05/201121/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dihydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
18EUCTR2010-022818-19-IE
(EUCTR)
08/04/201115/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 15.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
19EUCTR2010-022818-19-SE
(EUCTR)
07/04/201109/02/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden;United States;Canada
20EUCTR2010-022818-19-GB
(EUCTR)
22/03/201110/01/2011Clinical Study of Dexpramipexole in Amyotrophic Lateral Sclerosis (ALS)A randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of Dexpramipexole in subjects with amyotrophic lateral sclerosis. - EMPOWER amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dexpramipexole
Product Code: BIIB050 / KNS-760704
INN or Proposed INN: Dexpramipexole Dichydrochloride
Other descriptive name: Dexpramipexole
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
915United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden
21NCT01281189
(ClinicalTrials.gov)
March 201120/1/2011Phase 3 Study of Dexpramipexole in ALSA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: Dexpramipexole;Drug: PlaceboKnopp BiosciencesNULLCompleted18 Years80 YearsAll943Phase 3United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom