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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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 ...	A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or ...	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; ...
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 ...	A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: PHENYLBUTYRATE Other descriptive name: PHENYLBUTYRATE INN or ...	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; ...
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 Phe ...	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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other ...	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; ...
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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other ...	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; ...
6	ChiCTR2100051913	2021-12-31	2021-10-09	Sodium PhenylbutyrateGranules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Later ...	Sodium PhenylbutyrateGranules Combined with Tauroursodeoxycholic Acid Capsules for Amyotrophic Later ...	Amyotrophic lateral sclerosis	Experimental group:Sodium phenylbutyrategranules + tauroursodeoxycholic acidcapsules;Control group:S ...	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	NULL	Pending	18	80	Both	Experimental group:136;Control group:68;	N/A	China
7	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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	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 ...	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; ...
8	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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other ...	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; ...
9	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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other ...	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; ...
10	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 Scler ...	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety ...	ALS (amyotrophic lateral sclerosis) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term ...	Product Code: AMX0035 INN or Proposed INN: phenylbutyrate INN or Proposed INN: Ursodoxicoltaurine Other ...	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; ...

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