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 | NCT05286372 (ClinicalTrials.gov) | April 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 | Available | 18 Years | N/A | All | NULL | ||
| 2 | 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 | United States;Portugal;France;Spain;Belgium;Poland;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | EUCTR2021-000250-26-IT (EUCTR) | 14/12/2021 | 18/10/2021 | 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);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AMX0035 Product Code: [AMX0035] INN or Proposed INN: Sodio phenylbutyrate INN or Proposed INN: Tauroursodeoxycholic Acid | 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 | ||
| 4 | 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 | ||
| 5 | NCT05021536 (ClinicalTrials.gov) | October 28, 2021 | 20/8/2021 | Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment | 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) | Amyotrophic Lateral Sclerosis | Other: Placebo;Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Recruiting | 18 Years | N/A | All | 600 | Phase 3 | United States;Puerto Rico |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | Sweden;Italy;United Kingdom;Netherlands;Germany;Ireland;Belgium;Poland;Spain;United States;France;Portugal | ||
| 9 | 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 | ||
| 10 | NCT04516096 (ClinicalTrials.gov) | November 22, 2020 | 9/8/2020 | A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS) | AMX0035 for Amyotrophic Lateral Sclerosis - Compassionate Use Protocol | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 40 | Phase 2/Phase 3 | United States |
| 11 | NCT03488524 (ClinicalTrials.gov) | March 29, 2018 | 23/3/2018 | Open Label Extension Study of AMX0035 in Patients With ALS | Open Label Extension Study of AMX0035 in Patients With ALS | Amyotrophic Lateral Sclerosis;ALS | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | Massachusetts General Hospital Neurology Clinical Research Institute | Completed | N/A | N/A | All | 95 | Phase 2 | United States |
| 12 | NCT03127514 (ClinicalTrials.gov) | June 22, 2017 | 12/4/2017 | AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS) | Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALS | Amyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Diseases;Neurodegenerative Diseases;Spinal Cord Diseases;TDP-43 Proteinopathies;Nervous System Diseases;Central Nervous System Diseases | Drug: AMX0035;Other: Placebo | Amylyx Pharmaceuticals Inc. | ALS Finding a Cure Foundation;ALS Association;Northeast ALS Consortium;Massachusetts General Hospital Neurology Clinical Research Institute;Leandro P. Rizzuto Foundation | Completed | 18 Years | 80 Years | All | 137 | Phase 2/Phase 3 | United States |