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

  
13 trials found
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PhaseCountries
1EUCTR2022-002348-33-ES
(EUCTR)
22/12/202227/09/2022A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Poland;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
2EUCTR2022-002348-33-NL
(EUCTR)
06/12/202211/10/2022A 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 A35-0A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
3NCT05286372
(ClinicalTrials.gov)
September 23, 20229/3/2022An Intermediate Size Expanded Access Protocol of AMX0035 for ALSAn 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 SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLApproved for marketing18 YearsN/AAllUnited States;Puerto Rico
4EUCTR2021-000250-26-PT
(EUCTR)
29/04/202208/10/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3France;United States;Portugal;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
5EUCTR2021-000250-26-PL
(EUCTR)
23/02/202222/11/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Belgium;Spain;Poland;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
6ChiCTR2100051913
2021-12-312021-10-09Sodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical TrialSodium Phenylbutyrate Granules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Lateral Sclerosis: A Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial Amyotrophic lateral sclerosisExperimental group:Sodium phenylbutyrate granules + tauroursodeoxycholic acid capsules;Control group:Sodium phenylbutyrate placebo + tauroursodeoxycholic acid placebo;Peking Union Medical College Hospital, Chinese Academy of Medical SciencesNULLPending1880BothExperimental group:136;Control group:68;N/AChina
7EUCTR2021-000250-26-IT
(EUCTR)
14/12/202118/10/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
8EUCTR2021-000250-26-FR
(EUCTR)
22/11/202125/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;France;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2021-000250-26-DE
(EUCTR)
27/10/202122/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
10EUCTR2021-000250-26-NL
(EUCTR)
03/09/202106/07/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden
11EUCTR2021-000250-26-SE
(EUCTR)
26/08/202128/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
12NCT03127514
(ClinicalTrials.gov)
June 22, 201712/4/2017AMX0035 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 ALSAmyotrophic Lateral Sclerosis;Motor Neuron Disease;Neuromuscular Diseases;Neurodegenerative Diseases;Spinal Cord Diseases;TDP-43 Proteinopathies;Nervous System Diseases;Central Nervous System DiseasesDrug: AMX0035;Other: PlaceboAmylyx Pharmaceuticals Inc.ALS Finding a Cure Foundation;ALS Association;Northeast ALS Consortium;Massachusetts General Hospital Neurology Clinical Research Institute;Leandro P. Rizzuto FoundationCompleted18 Years80 YearsAll137Phase 2/Phase 3United States
13NCT00107770
(ClinicalTrials.gov)
April 20057/4/2005Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: sodium phenylbutyrateDepartment of Veterans AffairsMuscular Dystrophy AssociationCompleted18 YearsN/ABoth40Phase 1/Phase 2United States