2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | EUCTR2020-004590-51-IT (EUCTR) | 24/01/2022 | 07/06/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: nd Product Code: [BIIB067 (ISIS666853)] INN or Proposed INN: tofersen Other descriptive name: BIIB067 | BIOGEN IDEC RESEARCH LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2020-004590-51-DE (EUCTR) | 15/09/2021 | 19/03/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Germany;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2016-003225-41-ES (EUCTR) | 28/06/2021 | 14/06/2021 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand | ||
| 4 | EUCTR2020-004590-51-FR (EUCTR) | 03/06/2021 | 01/04/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Brazil;Belgium;Poland;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2020-004590-51-ES (EUCTR) | 17/05/2021 | 01/09/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation - ATLAS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10052653;Term: Amyotrophic lateral sclerosis gene carrier;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 6 | NCT04856982 (ClinicalTrials.gov) | May 17, 2021 | 20/4/2021 | A Study of BIIB067 When Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation | Drug: BIIB067 (Tofersen);Drug: Placebo | Biogen | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Sweden;United Kingdom |
| 7 | EUCTR2016-003225-41-DK (EUCTR) | 16/12/2020 | 09/06/2020 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Denmark;Australia;Germany;Japan;New Zealand | ||
| 8 | EUCTR2015-004098-33-DK (EUCTR) | 23/03/2020 | 02/03/2020 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation - VALOR (Part C) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | Sweden;Japan;Italy;United Kingdom;Germany;Denmark;Australia;Belgium;Poland;Canada;United States;France | ||
| 9 | EUCTR2016-003225-41-DE (EUCTR) | 06/09/2018 | 15/09/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;New Zealand | ||
| 10 | EUCTR2016-003225-41-BE (EUCTR) | 10/04/2017 | 10/04/2017 | Long-Term Evaluation of BIIB067 | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB067 Administered to Previously Treated Adults with Amyotrophic Lateral Sclerosis Caused by Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;European Union;Canada;Belgium;Poland;Australia;Denmark;Germany;Japan;Korea, Republic of | ||
| 11 | EUCTR2015-004098-33-DE (EUCTR) | 16/08/2016 | 07/12/2015 | An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS) | A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10077024;Term: Familial amyotrophic lateral sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: BIIB067 (ISIS666853) INN or Proposed INN: Tofersen Other descriptive name: BIIB067 | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 1;Phase 2;Phase 3 | France;United States;Canada;Poland;Belgium;Denmark;Australia;Germany;United Kingdom;Italy;Japan;Sweden |