113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| 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 | EUCTR2022-000389-16-ES (EUCTR) | 14/07/2022 | 15/07/2022 | A Phase 3 study to determine the Efficacy and Safety of Losmapimod inTreating Patients with Facioscapulohumeral Muscular Dystrophy | A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients with Facioscapulohumeral Muscular Dystrophy | Facioscapulohumeral Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Losmapimod Product Code: FTX-1821 INN or Proposed INN: Losmapimod | Fulcrum Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | France;United States;Canada;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 2 | NCT05397470 (ClinicalTrials.gov) | June 16, 2022 | 4/5/2022 | Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (Reach) | A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (Reach) | Facioscapulohumeral Muscular Dystrophy (FSHD) | Drug: Losmapimod;Drug: Placebo oral tablet | Fulcrum Therapeutics | NULL | Recruiting | 18 Years | 65 Years | All | 230 | Phase 3 | United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 3 | NCT04264442 (ClinicalTrials.gov) | February 13, 2020 | 30/1/2020 | Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE) | Facioscapulohumeral Muscular Dystrophy (FSHD) | Drug: Losmapimod | Fulcrum Therapeutics | NULL | Active, not recruiting | 18 Years | 65 Years | All | 76 | Phase 2 | United States;Canada;France;Spain;Germany |
| 4 | EUCTR2019-001181-15-ES (EUCTR) | 29/10/2019 | 29/10/2019 | Safety and Efficacy of Losmapimod in Patients with FSHD | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD) | Facioscapulohumeral Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Losmapimod Product Code: FTX-1821 INN or Proposed INN: LOSMAPIMOD | Fulcrum Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Spain;Germany | ||
| 5 | EUCTR2019-001181-15-FR (EUCTR) | 17/09/2019 | 29/05/2019 | Safety and Efficacy of Losmapimod in Patients with FSHD | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD) | Facioscapulohumeral Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Losmapimod Product Code: FTX-1821 INN or Proposed INN: LOSMAPIMOD | Fulcrum Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Spain;Germany | ||
| 6 | NCT04004000 (ClinicalTrials.gov) | August 23, 2019 | 25/6/2019 | Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension | An Open-Label Pilot Study of Losmapimod to Evaluate the Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments in Subjects With Facioscapulohumeral Muscular Dystrophy 1 (FSHD1) With Extension | Facioscapulohumeral Muscular Dystrophy 1 | Drug: Losmapimod | Fulcrum Therapeutics | NULL | Active, not recruiting | 18 Years | 65 Years | All | 14 | Phase 2 | Netherlands |
| 7 | NCT04003974 (ClinicalTrials.gov) | August 9, 2019 | 25/6/2019 | Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) | Facioscapulohumeral Muscular Dystrophy (FSHD) | Drug: Losmapimod;Drug: Placebo oral tablet | Fulcrum Therapeutics | NULL | Completed | 18 Years | 65 Years | All | 80 | Phase 2 | United States;Canada;France;Spain;Germany |