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. | 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 | 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 | ||
| 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: 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 | |
| 3 | 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 |
| 4 | JPRN-UMIN000001455 | 2008/10/01 | 23/10/2008 | Open 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 weeks | Department of NeurologyChiba University Graduate School of Medicine | NULL | 20years-old | Not applicable | Male | 10 | Not selected | Japan | ||
| 5 | 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 |
| 6 | 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 |
| 7 | 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) | 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 |