BIIB050 / KNS-760704 ( DrugBank: - )


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7

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
1EUCTR2010-022818-19-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
2EUCTR2010-022818-19-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
3EUCTR2010-022818-19-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
4EUCTR2010-022818-19-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
5EUCTR2010-022818-19-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
6EUCTR2010-022818-19-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
7EUCTR2010-022818-19-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