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
| 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 Patients | A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, First-In-Patient Study Of AJ201 To Evaluate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Adults With Spinal And Bulbar Muscular Atrophy (SMBA) | 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 | JPRN-JapicCTI-183981 | 02/11/2017 | 01/06/2018 | Specified 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 atrophy | Intervention 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. | NULL | recruiting | BOTH | 300 | NA | NULL | ||
| 3 | NCT03555578 (ClinicalTrials.gov) | November 2, 2017 | 1/6/2018 | Specified 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 Atrophy | Drug: Leuprorelin Acetate | Takeda | NULL | Recruiting | N/A | N/A | All | 300 | Japan | |
| 4 | JPRN-UMIN000026150 | 2017/04/25 | 31/03/2017 | Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial | Safety and efficacy of mexiletine hydrochroride in spinal and bulbar muscular atrophy (SBMA) :a multicenter, randomised, double-blind, placebo-controlled trial - Mexiletine in SBMA | 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 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 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 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 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 SBMA patients: A double-blind, placebo-controlled clinical study - Creatine in SBMA | Spinal and Bulbar Muscular Atrophy | Creatine 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 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 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: 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 of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy (SBMA) | 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 and Bulbar Muscular Atrophy (SBMA) | Spinal and Bulbar muscular atrophy | 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 Office | Jichi med college, Chiba univ., Univ of Tokyo, Tokyo med & dental univ. | Completed | >=30 YEARS | <70 YEARS | Male | 100 | Phase 2 | Japan |
| 11 | EUCTR2010-022558-18-IT (EUCTR) | 11/10/2010 | 28/09/2012 | A 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 PADOVA | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | Italy | ||||
| 12 | JPRN-UMIN000001455 | 2008/10/01 | 23/10/2008 | Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS) | Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS) - Open clinical trial of Leuprorelin Acetate (SR) in patients with KAS | Kennedy-Alter-Sung syndrome (KAS) | Leuprorelin acetate (SR) 11.25mg subcutaneous infection per 12 weeks | Department of NeurologyChiba University Graduate School of Medicine | NULL | 20years-old | Not applicable | Male | 10 | Not selected | Japan | |
| 13 | NCT00851461 (ClinicalTrials.gov) | April 2008 | 25/2/2009 | Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy | Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients | Spinobulbar Muscular Atrophy;Kennedy's Disease | Drug: Goserelin;Procedure: Electrophysiologic study;Procedure: tissue biopsy | Ramathibodi Hospital | AstraZeneca | Completed | 20 Years | N/A | Male | 10 | Phase 4 | Thailand |
| 14 | JPRN-JMA-IIA00111 | 29/08/2007 | 22/02/2013 | Long 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 Sobue | Ichiro Yabe, Masashi Aoki, Imaharu Nakano, Kazuaki Kanai, Hidehiro Mizusawa, Tomotaka Yamamoto, Kazuko Hasegawa, Masatoyo Nishizawa, Hiroaki Miyajima, Norio Kanda, Kenji Nakajima, Akira Tsujino, Makoto Uchino | Completed | >=30 YEARS | <71 YEARS | Male | 152 | Phase 3 | Japan |
| 15 | JPRN-JMA-IIA00009 | 13/09/2006 | 24/08/2006 | Phase 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 Office | Hokkaido 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 University | Completed | >=30 YEARS | <70 YEARS | Male | 170 | Phase 3 | Japan |
| 16 | NCT00303446 (ClinicalTrials.gov) | March 2006 | 15/3/2006 | Dutasteride 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 Atrophy | Drug: Dutasteride;Drug: Placebo | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | N/A | Male | 57 | Phase 2 | United States |
| 17 | JPRN-UMIN000000474 | 2003/09/01 | 01/09/2006 | Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) | Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) - Clinical Trial of Leuprorelin acetate in Patients with 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 Medicine | NULL | Complete: follow-up complete | 30years-old | 70years-old | Male | 40 | Phase 2 | Japan |
| 18 | NCT00004771 (ClinicalTrials.gov) | October 1992 | 24/2/2000 | Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease | Spinal Muscular Atrophy;Amyotrophic Lateral Sclerosis;Spinobulbar Muscular Atrophy | Drug: leuprolide;Drug: testosterone | National Center for Research Resources (NCRR) | Ohio State University | Completed | 18 Years | N/A | Male | 40 | Phase 2 | NULL |