Emflaza® (deflazacort) (DrugBank: Deflazacort)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 113 | 筋ジストロフィー | 3 |
| 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 | EUCTR2018-004740-36-DK (EUCTR) | 29/10/2019 | 25/06/2019 | A clinical study to evaluate how safe and effective the drug Deflazacort (EMFLAZA®) compared to placebo is in subjects with Limb-Girdle Muscular Dystrophy Type 2I | A MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I | Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) MedDRA version: 20.0;Level: PT;Classification code 10028356;Term: Muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Denmark;Russian Federation;Norway;Germany;Sweden | ||
| 2 | EUCTR2018-004740-36-DE (EUCTR) | 14/10/2019 | 29/04/2019 | A clinical study to evaluate how safe and effective the drug Deflazacort (EMFLAZA®) compared to placebo is in subjects with Limb-Girdle Muscular Dystrophy Type 2I | A MULTICENTER RANDOMIZED PLACEBO-CONTROLLED PHASE 3 STUDY ON THE SAFETY AND EFFICACY OF DEFLAZACORT (EMFLAZA®) IN SUBJECTS WITH LIMB-GIRDLE MUSCULAR DYSTROPHY 2I (LGMD2I | Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) MedDRA version: 20.0;Level: PT;Classification code 10028356;Term: Muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT Trade Name: EMFLAZA® (DEFLAZACORT) Product Name: EMFLAZA® (deflazacort) Product Code: EMFLAZA® (deflazacort) INN or Proposed INN: Deflazacort Other descriptive name: DEFLAZACORT | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Denmark;Russian Federation;Norway;Germany;Sweden | ||
| 3 | NCT03642145 (ClinicalTrials.gov) | October 31, 2018 | 10/7/2018 | A Study of Deflazacort (Emflaza®) in Participants With Duchenne Muscular Dystrophy (DMD) | A 52-Week Phase 3B Randomized Open-Label Study Evaluating the Safety and Pharmacokinetics of Emflaza® (Deflazacort) Compared to a Comparable Natural History Control Group in Males Aged =2 to <5 Years With Duchenne Muscular Dystrophy (DMD) Followed by a 52-Week Extension Period | Duchenne Muscular Dystrophy | Drug: Deflazacort | PTC Therapeutics | NULL | Withdrawn | 2 Years | 4 Years | Male | 0 | Phase 3 | United States |