113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| 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 | EUCTR2016-001654-18-DE (EUCTR) | 13/11/2017 | 23/06/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy | A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | 159 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 2 | EUCTR2016-001654-18-FR (EUCTR) | 10/11/2017 | 30/10/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: no Male: yes | 160 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 3 | EUCTR2016-001654-18-BE (EUCTR) | 10/11/2017 | 26/06/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy | A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 (BMS-986089) in ambulatory boys with Duchenne Muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BMS-986089-01 (RO7239361) Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: RO7239361 (BMS-986089) INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01 (RO7239361) , anti-myostatin Product Name: BMS-986089-01 (RO7239361) Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: RO7239361 (BMS-986089) INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01 (RO7239361), anti-myostatin Product Name: BMS-986089-01 (RO7239361) Injections, 35 mg/Syringe (50 mg/mL) Product Code: RO7239361 (BMS-986089) INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01 (RO7239361), anti-myostatin Product Name: BMS-986089-01 (RO7239361) Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: RO7239361 (BMS-986089) INN or Proposed INN: Anti-myostati | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | 159 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2016-001654-18-GB (EUCTR) | 01/11/2017 | 27/06/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, Anti-myostatin Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | 159 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 5 | EUCTR2016-001654-18-NL (EUCTR) | 26/10/2017 | 12/07/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, Anti-myostatin Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | 159 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Japan;Sweden | ||
| 6 | EUCTR2016-001654-18-IT (EUCTR) | 19/09/2017 | 07/02/2018 | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy - - | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy - - | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: no Male: yes | 160 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 7 | EUCTR2016-001654-18-ES (EUCTR) | 04/09/2017 | 04/07/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy | A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BMS-986089-01 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: BMS-986089-01 Injections, 35 mg/Syringe (50 mg/mL) Product Code: BMS-986089 INN or Proposed INN: Anti-Myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: no Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 8 | EUCTR2016-001654-18-SE (EUCTR) | 12/08/2017 | 15/06/2017 | Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy | A randomized, double blind, placebo-controlled, study to assess the efficacy, safety, and tolerability of RO7239361 in ambulatory boys with Duchenne Muscular dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: RO7239361 Injections, 7.5 mg/Syringe (10.7 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, Anti-myostatin Product Name: RO7239361 Injections, 15 mg/Syringe (21.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 35 mg/Syringe (50 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin Product Name: RO7239361 Injections, 50 mg/Syringe (71.4 mg/mL) Product Code: RO7239361 INN or Proposed INN: Anti-myostatin Adnectin Other descriptive name: BMS-986089-01, anti-myostatin | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | 159 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Canada;Argentina;Belgium;Australia;Germany;Netherlands;Japan;Sweden | ||
| 9 | NCT02515669 (ClinicalTrials.gov) | December 2, 2015 | 29/7/2015 | Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD | A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7239361 (BMS-986089) in Ambulatory Boys With Duchenne Muscular Dystrophy | Muscular Dystrophy (DMD) | Drug: RO7239361;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 5 Years | 10 Years | Male | 43 | Phase 1/Phase 2 | United States;Canada |