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 | EUCTR2022-002348-33-ES (EUCTR) | 22/12/2022 | 27/09/2022 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Poland;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 2 | EUCTR2022-002348-33-NL (EUCTR) | 06/12/2022 | 11/10/2022 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-0 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 3 | NCT05286372 (ClinicalTrials.gov) | September 23, 2022 | 9/3/2022 | An Intermediate Size Expanded Access Protocol of AMX0035 for ALS | An Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Approved for marketing | 18 Years | N/A | All | United States;Puerto Rico | ||
| 4 | EUCTR2021-000250-26-PT (EUCTR) | 29/04/2022 | 08/10/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | France;United States;Portugal;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2021-000250-26-PL (EUCTR) | 23/02/2022 | 22/11/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2021-000250-26-FR (EUCTR) | 22/11/2021 | 25/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;United States;France;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2021-000250-26-DE (EUCTR) | 27/10/2021 | 22/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2021-000250-26-ES (EUCTR) | 05/10/2021 | 23/07/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: fenilbutirato INN or Proposed INN: Ursodoxicoltaurina Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: Fenilbutirato INN or Proposed INN: Ursodoxicoltaurina Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 9 | EUCTR2021-000250-26-NL (EUCTR) | 03/09/2021 | 06/07/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 10 | EUCTR2021-000250-26-SE (EUCTR) | 26/08/2021 | 28/06/2021 | A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix | ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;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 Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE INN or Proposed INN: Ursodoxicoltaurine Other descriptive name: taurursodiol | Amylyx Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden |