1. 球脊髄性筋萎縮症 Spinal and bulbar muscular atrophy Clinical trials / Disease details

臨床試験数 : 18 / 薬物数 : 15 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 17

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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	NCT05517603 (ClinicalTrials.gov)	February 28, 2023	23/8/2022	A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patient ...	A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, First-In-Patient Study Of AJ201 To Evalu ...	Spinal and Bulbar Muscular Atrophy;Kennedy's Disease	Drug: AJ201;Drug: Placebo	AnnJi Pharmaceutical Co., Ltd.	NULL	Recruiting	18 Years	N/A	Male	24	Phase 1/Phase 2	United States
2	NCT03555578 (ClinicalTrials.gov)	November 2, 2017	1/6/2018	Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spin ...	Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spin ...	Spinal and Bulbar Muscular Atrophy	Drug: Leuprorelin Acetate	Takeda	NULL	Recruiting	N/A	N/A	All	300		Japan
3	JPRN-JapicCTI-183981	02/11/2017	01/06/2018	Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spin ...	Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spin ...	Spinal and bulbar muscular atrophy	Intervention name : Leuprorelin Acetate Dosage And administration of the intervention : Leuprorelin Ace ...	TAKEDA PHARMACEUTICAL COMPANY LTD.	NULL	recruiting			BOTH	300	NA	NULL
4	JPRN-UMIN000026150	2017/04/25	31/03/2017	Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy(SBMA) :a multi ...	Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy(SBMA) :a multi ...	Spinal and Bulbar Muscular Atrophy	Mexiletine Hydrochloride 300mg daily, for 4 weeks placebo for 4 weeks	Nagoya University Graduate School of Medicine	NULL	Complete: follow-up continuing	20years-old	80years-old	Male	20	Phase 2	Japan
5	EUCTR2013-002608-15-DE (EUCTR)	15/08/2014	15/04/2014	A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy	A two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of ...	Spinal and bulbar muscular atrophy(SBMA) MedDRA version: 18.1;Level: PT;Classification code 10068597 ...	Product Code: BVS857 INN or Proposed INN: -	Novartis Pharma Services AG	NULL	Not Recruiting			Female: no Male: yes	38	Phase 2	United States;Denmark;Germany;Italy
6	EUCTR2013-002608-15-IT (EUCTR)	12/06/2014	14/02/2014	A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy	A two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of ...	Spinal and bulbar muscular atrophy(SBMA) MedDRA version: 16.1;Level: PT;Classification code 10068597 ...	Product Code: BVS857 INN or Proposed INN: NA Other descriptive name: NA	Novartis Farma SpA	NULL	Not Recruiting			Female: no Male: yes	38	Phase 2	United States;Denmark;Germany;Italy
7	JPRN-UMIN000012503	2014/06/01	25/12/2013	Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study	Effect of creatine in SBMApatients: A double-blind, placebo-controlled clinical study - Creatine in ...	Spinal and Bulbar Muscular Atrophy	Creatinemonohydrate 10 g, daily for 8 weeks Creatinemonohydrate 15 g, daily for 8 weeks placebo for 8 ...	Department of Neurology, Nagoya University Graduate School of Medicine	NULL	Complete: follow-up continuing	20years-old	80years-old	Male	45	Not applicable	Japan
8	EUCTR2013-002608-15-DK (EUCTR)	19/05/2014	21/03/2014	A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophy	A two-part placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of ...	Spinal and bulbar muscular atrophy(SBMA) MedDRA version: 18.1;Level: PT;Classification code 10068597 ...	Product Code: BVS857	Novartis Pharma Services AG	NULL	Not Recruiting			Female: no Male: yes	38	Phase 2	United States;Denmark;Germany;Italy
9	NCT02024932 (ClinicalTrials.gov)	February 4, 2014	29/12/2013	Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy	A Two-part Placebo-controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy o ...	Spinal and Bulbar Muscular Atrophy	Drug: BVS857;Drug: Placebo	Novartis Pharmaceuticals	NULL	Completed	18 Years	N/A	Male	37	Phase 2	United States;Denmark;Germany;Italy
10	JPRN-JMA-IIA00080	02/2012	26/01/2012	Phase 2 Clinical Trial of Leuprorelin acetate in patients with SBMA (JASMITT-2)	Double-blind Placebo-controlled Phase 2 Clinical Trial of TAP-144-SR (3M) in patients with Spinal an ...	Spinal and Bulbar muscular atrophy	Intervention type:DRUG. Intervention1:TAP-144-SR(3M), Dose form:INJECTION, Route of administration:S ...	JASMITT Clinical Trial Office	Jichi med college, Chiba univ., Univ of Tokyo, Tokyo med & dental univ.	Completed	>=30 YEARS	<70 YEARS	Male	100	Phase 2	Japan

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