2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-006119-70-DE (EUCTR) | 31/08/2012 | 20/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 2 | EUCTR2011-006119-70-NL (EUCTR) | 30/08/2012 | 14/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 3 | EUCTR2011-006119-70-BE (EUCTR) | 13/08/2012 | 14/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Canada;Spain;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | ||
| 4 | EUCTR2011-006119-70-GB (EUCTR) | 10/08/2012 | 18/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 5 | EUCTR2011-006119-70-IE (EUCTR) | 03/08/2012 | 07/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 6 | EUCTR2011-006119-70-ES (EUCTR) | 27/07/2012 | 11/06/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 7 | NCT01622088 (ClinicalTrials.gov) | June 2012 | 3/5/2012 | Phase 3 Extension Study of Dexpramipexole in ALS | An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole | Knopp Biosciences | Biogen | Terminated | 18 Years | 80 Years | All | 616 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom |
| 8 | EUCTR2011-006119-70-SE (EUCTR) | 15/05/2012 | 19/04/2012 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 850 | United States;Canada;Belgium;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 9 | NCT01536249 (ClinicalTrials.gov) | March 2012 | 16/2/2012 | Dexpramipexole and Cimetidine Drug Drug Interaction (DDI) | An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Cimetidine plus Dexpramipexole | Knopp Biosciences | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 1 | United States |
| 10 | NCT01511029 (ClinicalTrials.gov) | January 2012 | 9/1/2012 | Study 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 Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Dexpramipexole Placebo;Drug: Moxifloxacin | Knopp Biosciences | NULL | Completed | 18 Years | 60 Years | Both | 68 | Phase 1 | United States |
| 11 | NCT01449578 (ClinicalTrials.gov) | November 2011 | 22/9/2011 | Dexpramipexole SAD/MAD Study | A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Dexpramipexole Placebo | Knopp Biosciences | NULL | Completed | 18 Years | 55 Years | Both | 63 | Phase 1 | United States |
| 12 | NCT01424163 (ClinicalTrials.gov) | August 2011 | 28/7/2011 | Dexpramipexole Japanese PK Study | A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects | Amyotrophic Lateral Sclerosis | Drug: Single dose reduced;Drug: Single dose standard;Drug: Multiple Dose | Knopp Biosciences | Biogen | Completed | 18 Years | 60 Years | All | 57 | Phase 1 | United Kingdom |
| 13 | NCT01424176 (ClinicalTrials.gov) | July 2011 | 23/6/2011 | Dexpramipexole Renal PK Study | A Multicenter, Open-Label, Single-dose, Pharmacokinetic and Safety Study of Dexpramipexole (BIIB050) in Healthy Subjects and Subjects With Renal Impairment | Amyotrophic Lateral Sclerosis;Renal Insufficiency | Drug: Dexpramipexole (dose 1);Drug: Dexpramipexole (dose 2) | Knopp Biosciences | NULL | Completed | 18 Years | 75 Years | Both | 36 | Phase 1 | United States |
| 14 | EUCTR2010-022818-19-ES (EUCTR) | 09/06/2011 | 21/02/2011 | A 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 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 804 | Phase 3 | Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Sweden | ||
| 15 | EUCTR2010-022818-19-BE (EUCTR) | 07/06/2011 | 24/01/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | Phase 3 | United States;Canada;Spain;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 16 | EUCTR2010-022818-19-NL (EUCTR) | 24/05/2011 | 11/05/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Germany;Netherlands;United Kingdom;Sweden | |||
| 17 | EUCTR2010-022818-19-DE (EUCTR) | 12/05/2011 | 21/02/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 18 | EUCTR2010-022818-19-IE (EUCTR) | 08/04/2011 | 15/02/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 19 | EUCTR2010-022818-19-SE (EUCTR) | 07/04/2011 | 09/02/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden;United States;Canada | |||
| 20 | EUCTR2010-022818-19-GB (EUCTR) | 22/03/2011 | 10/01/2011 | Clinical 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 915 | United States;Canada;Spain;Ireland;Australia;Netherlands;Germany;United Kingdom;Sweden | |||
| 21 | NCT01281189 (ClinicalTrials.gov) | March 2011 | 20/1/2011 | Phase 3 Study of Dexpramipexole in ALS | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Dexpramipexole;Drug: Placebo | Knopp Biosciences | NULL | Completed | 18 Years | 80 Years | All | 943 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;Spain;Sweden;United Kingdom |