Risdiplam ( DrugBank: Risdiplam )

1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
3	脊髄性筋萎縮症	44

3. 脊髄性筋萎縮症

臨床試験数 : 237 / 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75

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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	NCT05386680 (ClinicalTrials.gov)	January 12, 2023	18/5/2022	Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 A ...	Phase IIIb, Open-label, Single-arm, Multi-center Study to Evaluate the Safety, Tolerability and Effi ...	Spinal Muscular Atrophy	Genetic: OAV101	Novartis Pharmaceuticals	NULL	Recruiting	2 Years	12 Years	All	28	Phase 3	Canada;Japan;Netherlands;Spain
2	NCT05522361 (ClinicalTrials.gov)	September 15, 2022	24/5/2022	Risdiplam in Patients With Spinal Muscular Atrophy Previously Treated With Nusinersen	RisdiplamExchange in Patients With Spinal Muscular Atrophy (SMA) Previously and Exclusively Treated ...	Spinal Muscular Atrophy	Drug: Risdiplam	Clinic for Special Children	Genentech, Inc.	Not yet recruiting	2 Years	35 Years	All	10	Phase 4	United States
3	NCT05115110 (ClinicalTrials.gov)	June 2, 2022	1/11/2021	A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam(RO7034067) ...	A Two-Part, Seamless, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Investigat ...	Spinal Muscular Atrophy (SMA)	Drug: RO7204239;Drug: Placebo;Drug: Risdiplam	Hoffmann-La Roche	NULL	Recruiting	2 Years	25 Years	All	259	Phase 2/Phase 3	United States;Belgium;Italy;Netherlands;Poland;United Kingdom;Germany
4	EUCTR2021-003417-19-NL (EUCTR)	25/05/2022	11/01/2022	A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ...	A TWO-PART, SEAMLESS, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO INVESTIGAT ...	Spinal Muscular Atrophy (SMA);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: N/A Product Code: RO7204239/F01-01 INN or Proposed INN: N/A Other descriptive name: GYM32 ...	F.Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2;Phase 3	United States;Poland;Belgium;Germany;Netherlands;United Kingdom;Italy
5	EUCTR2021-005314-34-ES (EUCTR)	11/05/2022	09/03/2022	Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with L ...	Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab ( ...	Spinal Muscular Atrophy (SMA) MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spi ...	Product Name: Apitegromab Product Code: SRK-015 INN or Proposed INN: Apitegromab	Scholar Rock, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	204	Phase 3	France;United States;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
6	EUCTR2021-001294-23-ES (EUCTR)	31/03/2022	20/12/2021	A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrop ...	A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrop ...	Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ...	Product Name: Nusinersen Product Code: ISIS 396443, BIIB058 INN or Proposed INN: NUSINERSEN Other descr ...	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	135	Phase 3	Canada;Poland;Brazil;Belgium;Spain;Australia;Germany;Italy;Switzerland;Japan
7	NCT05232929 (ClinicalTrials.gov)	March 29, 2022	31/1/2022	Long-Term Follow-Up Study of Risdiplam in Participants With Spinal Muscular Atrophy (SMA)	Long-Term Follow-Up Study of Patients With Spinal Muscular Atrophy Receiving Risdiplam Treatment	Spinal Muscular Atrophy	Drug: Risdiplam	Genentech, Inc.	NULL	Recruiting	N/A	N/A	All	500	Phase 4	United States;Puerto Rico
8	EUCTR2021-001294-23-IT (EUCTR)	25/02/2022	17/12/2021	A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants with Spinal Muscular Atrop ...	A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrop ...	Muscular Atrophy, Spinal MedDRA version: 20.1;Level: PT;Classification code 10041582;Term: Spinal mu ...	Trade Name: Spinraza Product Name: .Nusinersen Product Code: [ ISIS 396443, BIIB058] Other descriptive ...	BIOGEN IDEC RESEARCH LIMITED	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	135	Phase 3	Canada;Spain;Poland;Brazil;Belgium;Australia;Germany;Switzerland;Japan;Italy
9	NCT05156320 (ClinicalTrials.gov)	February 24, 2022	1/12/2021	Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With ...	Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab ( ...	Spinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscu ...	Drug: Apitegromab;Drug: Placebo	Scholar Rock, Inc.	NULL	Recruiting	2 Years	21 Years	All	204	Phase 3	Germany;Italy;Netherlands;Poland;Spain;United Kingdom;Belgium;France;United States
10	NCT05067790 (ClinicalTrials.gov)	January 21, 2022	24/9/2021	A Study to Evaluate Higher Dose (HD) Nusinersen (BIIB058) in Participants With Spinal Muscular Atrop ...	A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients With Spinal Muscular Atrop ...	Spinal Muscular Atrophy	Drug: Nusinersen	Biogen	NULL	Recruiting	15 Years	50 Years	All	135	Phase 3	United States;Belgium;Brazil;Germany;Italy;Poland;Spain

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