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


臨床試験数 : 17 薬物数 : 16 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 17

  
No.TrialIDDate_
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1JPRN-JapicCTI-183981
02/11/201701/06/2018Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA)Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and bulbar muscular atrophy (SBMA) Spinal and bulbar muscular atrophyIntervention name : Leuprorelin Acetate
Dosage And administration of the intervention : Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLrecruitingBOTH300NANULL
2NCT03555578
(ClinicalTrials.gov)
November 2, 20171/6/2018Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)Spinal and Bulbar Muscular AtrophyDrug: Leuprorelin AcetateTakedaNULLRecruitingN/AN/AAll300Japan
3JPRN-UMIN000026150
2017/04/2531/03/2017Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial Spinal and Bulbar Muscular AtrophyMexiletine Hydrochloride 300mg daily, for 4 weeks
placebo for 4 weeks
Nagoya University Graduate School of MedicineNULLComplete: follow-up continuing20years-old80years-oldMale20Phase 2Japan
4EUCTR2013-002608-15-DE
(EUCTR)
15/08/201415/04/2014A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophyA two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of BVS857 in patients with spinal and bulbar muscularatrophy (SBMA) Spinal and bulbar muscular atrophy (SBMA)
MedDRA version: 18.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BVS857
INN or Proposed INN: -
Novartis Pharma Services AGNULLNot RecruitingFemale: no
Male: yes
38Phase 2United States;Denmark;Germany;Italy
5EUCTR2013-002608-15-IT
(EUCTR)
12/06/201414/02/2014A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophyA two-part placebo-controlled study to evaluate the safety, tolerability andpreliminary efficacy of BVS857 in patients with spinal and bulbar muscularatrophy (SBMA) Spinal and bulbar muscular atrophy (SBMA)
MedDRA version: 16.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BVS857
INN or Proposed INN: NA
Other descriptive name: NA
Novartis Farma SpANULLNot RecruitingFemale: no
Male: yes
38Phase 2United States;Denmark;Germany;Italy
6JPRN-UMIN000012503
2014/06/0125/12/2013Effect of creatine in SBMA patients: A double-blind, placebo-controlled clinical study Spinal and Bulbar Muscular AtrophyCreatine monohydrate 10 g, daily for 8 weeks
Creatine monohydrate 15 g, daily for 8 weeks
placebo for 8 weeks
Department of Neurology, Nagoya University Graduate School of MedicineNULLComplete: follow-up continuing20years-old80years-oldMale45Not applicableJapan
7EUCTR2013-002608-15-DK
(EUCTR)
19/05/201421/03/2014A study of the safety and effectiveness of BVS857 in spinal and bulbar muscular atrophyA two-part placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of BVS857 in patients with spinal and bulbar muscular atrophy (SBMA) Spinal and bulbar muscular atrophy (SBMA)
MedDRA version: 18.1;Level: PT;Classification code 10068597;Term: Bulbospinal muscular atrophy congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BVS857Novartis Pharma Services AGNULLNot RecruitingFemale: no
Male: yes
38Phase 2United States;Denmark;Germany;Italy
8NCT02024932
(ClinicalTrials.gov)
February 4, 201429/12/2013Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular AtrophyA Two-part Placebo-controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA)Spinal and Bulbar Muscular AtrophyDrug: BVS857;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AMale37Phase 2United States;Denmark;Germany;Italy
9JPRN-JMA-IIA00080
02/201226/01/2012Phase 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 and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar muscular atrophyIntervention type:DRUG. Intervention1:TAP-144-SR(3M) , Dose form:INJECTION, Route of administration:SUBCUTANEOUS. Control intervention1:placebo, Dose form:INJECTION, Route of administration:SUBCUTANEOUS.JASMITT Clinical Trial OfficeJichi med college, Chiba univ., Univ of Tokyo, Tokyo med & dental univ.Completed>=30 YEARS<70 YEARSMale100Phase 2Japan
10EUCTR2010-022558-18-IT
(EUCTR)
11/10/201028/09/2012A pilot trial with clenbuterol in spinal and bulbar muscular atrophy (SBMA).A pilot trial with clenbuterol in spinal and bulbar muscular atrophy (SBMA). spinal and bulbar muscular atrophy (SBMA)
MedDRA version: 15.0;Level: HLGT;Classification code 10029317;Term: Neuromuscular disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 15.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Level: LLT;Classification code 10047868;Term: Weakness of limbs;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: PT;Classification code 10013969;Term: Dyspnoea at rest;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MONORES*30CPR 20MCG
INN or Proposed INN: Clenbuterol
AZIENDA OSPEDALIERA DI PADOVANULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
Italy
11JPRN-UMIN000001455
2008/10/0123/10/2008Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS) Kennedy-Alter-Sung syndrome (KAS)Leuprorelin acetate (SR) 11.25mg subcutaneous infection per 12 weeksDepartment of NeurologyChiba University Graduate School of MedicineNULL20years-oldNot applicableMale10Not selectedJapan
12NCT00851461
(ClinicalTrials.gov)
April 200825/2/2009Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular AtrophyEffect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai PatientsSpinobulbar Muscular Atrophy;Kennedy's DiseaseDrug: Goserelin;Procedure: Electrophysiologic study;Procedure: tissue biopsyRamathibodi HospitalAstraZenecaCompleted20 YearsN/AMale10Phase 4Thailand
13JPRN-JMA-IIA00111
29/08/200722/02/2013Long Term Follow-up Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar Muscular Atrophy (SBMA)Intervention type:DRUG. Intervention1:TAP-144-SR(3M), Dose form:INJECTION, Route of administration:SUBCUTANEOUS, intended dose regimen:every 12 week. Control intervention1:N.A., Dose form:NOT APPLICABLE, Route of administration:NOT APPLICABLE , Intended dose regimen:N.A..Gen SobueIchiro Yabe, Masashi Aoki, Imaharu Nakano, Kazuaki Kanai, Hidehiro Mizusawa, Tomotaka Yamamoto, Kazuko Hasegawa, Masatoyo Nishizawa, Hiroaki Miyajima, Norio Kanda, Kenji Nakajima, Akira Tsujino, Makoto UchinoCompleted>=30 YEARS<71 YEARSMale152Phase 3Japan
14JPRN-JMA-IIA00009
13/09/200624/08/2006Phase III Clinical Trial of Leuprorelin acetate in Patients with SBMA (JASMITT)Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and Bulbar Muscular Atrophy (SBMA)Intervention type:DRUG. Intervention1:TAP-144-SR(3M), Dose form:INJECTION, Route of administration:SUBCUTANEOUS. Control intervention1:placebo, Dose form:INJECTION, Route of administration:SUBCUTANEOUS.JASMITT Clinical Trial OfficeHokkaido University, Tohoku University, Jichi Medical College, Chiba University, University of Tokyo, Tokyo Medical and Dental University, NHO Sagamitara hospital, Niigata University, Hamamatsu Medical college, Kobe University, Tottori University, Nagasaki University, Kumamoto UniversityCompleted>=30 YEARS<70 YEARSMale170Phase 3Japan
15NCT00303446
(ClinicalTrials.gov)
March 200615/3/2006Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)Phase II Clinical Trial to Examine the Efficacy and Safety of Dutasteride in Patients With Kennedy's Disease (Spinal and Bulbar Muscular Atrophy)Kennedy's Disease;Spinal and Bulbar Muscular AtrophyDrug: Dutasteride;Drug: PlaceboNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 YearsN/AMale57Phase 2United States
16JPRN-UMIN000000474
2003/09/0101/09/2006Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) Spinal and bulbar muscular atrophy (SBMA)Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks
Placebo subcutaneous injection every 4 weeks
Department of Neurology, Nagoya University School of MedicineNULLComplete: follow-up complete30years-old70years-oldMale40Phase 2Japan
17NCT00004771
(ClinicalTrials.gov)
October 199224/2/2000Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron DiseaseSpinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular AtrophyDrug: leuprolide;Drug: testosteroneNational Center for Research Resources (NCRR)Ohio State UniversityCompleted18 YearsN/AMale40Phase 2NULL