11 completed, 3 unknown, 1 active not recruiting, 1 approved for marketing. 8 Phase 1, 5 Phase 3, 2 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 7, Unknown 1 |
| Phase 3 | 5 | Completed 2, Active not recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 2 | 2 | Active not recruiting 1, Completed 1 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
Follow deflazacort: new trials by email Literature Review of deflazacort trials Research Report on deflazacort
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial Omega-3-based nutraceutical combination (Otoair Flogo), Bilastine 20 mg, Placebo Tablet or Capsule - Otits Media With Effusion | Phase 4 | Completed | Isola Tiberina - Gemelli Isola Hospital, Rome, Italy | 501 | 2025-10-01 | 2026-07-23 |
| Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls Methylprednisone, Deflazacort, Dexamethasone - Healthy Volunteers | Phase 1 | Unknown | Parc de Salut Mar | 50 | 2021-02-26 | 2021-04-01 |
| Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects Edasalonexent 2000 mg TID, Midazolam 2 MG/ML, Deflazacort 36Mg Tab - Healthy | Phase 1 | Completed | Catabasis Pharmaceuticals | 26 | 2020-08-08 | 2021-01-28 |
| Deflazacort Vs. Prednisolone in Acute-stage ABPA Deflazacort, Prednisolone - Allergic Bronchopulmonary Aspergillosis | Phase 2 / Phase 3 | Active not recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | 150 | 2020-01-15 | 2025-02-28 |
| A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I) Deflazacort - Limb-Girdle Muscular Dystrophy | Phase 3 | Terminated | PTC Therapeutics | 11 | 2019-10-31 | 2022-06-27 |
| Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus Deflazacort 30 MG Oral Tablet, Sugar pill - Impacted Third Molar Tooth | Phase 4 | Unknown | Yuzuncu Yil University | 35 | 2018-12-15 | 2023-08-22 |
| A Study of Deflazacort (Emflaza®) in Participants With Duchenne Muscular Dystrophy (DMD) Deflazacort - Duchenne Muscular Dystrophy | Phase 3 | Withdrawn | PTC Therapeutics | 2018-10-31 | 2019-06-21 | |
| Registry of IgA Nephropathy in Chinese Children Corticosteroid, Cyclophosphamide, Mycophenolate mofetil - IgA Nephropathy, Proteinuria in Nephrotic Range | Unknown | Peking University First Hospital | 1200 | 2016-01-01 | 2023-12-06 | |
| Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers Deflazacort - Healthy Volunteers | Phase 1 | Completed | PTC Therapeutics | 45 | 2015-06-01 | 2017-08-18 |
| A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics Deflazacort - Renal Impairment | Phase 1 | Completed | PTC Therapeutics | 16 | 2014-12-01 | 2017-08-18 |
| A Single Dose Evaluation of the Effects of Moderate Hepatic Impairment on Deflazacort Pharmacokinetics Deflazacort - Hepatic Impairment | Phase 1 | Completed | PTC Therapeutics | 16 | 2014-12-01 | 2017-08-18 |
| A Pharmacokinetic Study of Oral Deflazacort in Children and Adolescent Subjects With Duchenne Muscular Dystrophy Deflazacort - Duchenne Muscular Dystrophy | Phase 1 | Completed | PTC Therapeutics | 24 | 2014-12-01 | 2017-08-18 |
| An Open-Label, Long-Term Extension Study to Evaluate the Safety and Tolerability Deflazacort Deflazacort - Duchenne Muscular Dystrophy | Phase 1 | Completed | PTC Therapeutics | 24 | 2014-12-01 | 2017-12-08 |
| Evaluate Effects of Multiple Doses of Rifampin and Clarithromycin on the Single Dose Pharmacokinetics of Deflazacort Deflazacort and rifampin, Deflazacort and Clarithromycin - Healthy Volunteers | Phase 1 | Completed | PTC Therapeutics | 58 | 2014-11-01 | 2017-08-18 |
| Heart Rate Variability in Individuals With Duchenne Muscular Dystrophy Duchenne Muscular Dystrophy group with Deflazacort, Duchenne Muscular Dystrophy group with Prednisone/Predisolone, Duchenne Muscular Dystrophy group without Corticosteroids therapy - Duchenne Muscular Dystrophy | Completed | University of Sao Paulo | 40 | 2013-03-01 | 2021-02-05 | |
| Finding the Optimum Regimen for Duchenne Muscular Dystrophy Prednisone, Deflazacort - Duchenne Muscular Dystrophy | Phase 3 | Completed | University of Rochester | 196 | 2013-01-01 | 2022-08-12 |
| Deflazacort in Dysferlinopathies deflazacort, placebo - LGMD2B, Miyoshi Myopathy | Phase 2 / Phase 3 | Completed | Ludwig-Maximilians - University of Munich | 25 | 2003-09-01 | 2015-09-02 |
| Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy Deflazacort - Duchenne Muscular Dystrophy | Approved for marketing | PTC Therapeutics | 2018-02-28 |
Muscular Dystrophy, Duchenne (6) · Muscular Dystrophies (2) · Aspergillosis, Allergic Bronchopulmonary (1) · Asthma (1) · Dysferlinopathy (1) · Edema (1) · Glomerulonephritis, IGA (1) · Hearing Loss (1) · Hearing Loss, Conductive (1) · Limb-girdle muscular dystrophy, type 2B (1) · Miyoshi myopathy (1) · Muscular Dystrophies, Limb-Girdle (1) · Neuromuscular Diseases (1) · Otitis Media with Effusion (1) · Pain (1)
PTC Therapeutics (9) · Catabasis Pharmaceuticals (1) · Isola Tiberina - Gemelli Isola Hospital, Rome, Italy (1) · Ludwig-Maximilians - University of Munich (1) · Parc de Salut Mar (1) · Peking University First Hospital (1) · Post Graduate Institute of Medical Education and Research, Chandigarh (1) · University of Rochester (1) · University of Sao Paulo (1) · Yuzuncu Yil University (1)
United States (10) · Germany (3) · Canada (2) · Italy (2) · China (1) · Denmark (1) · France (1) · India (1) · Norway (1) · Russia (1) · Spain (1) · Sweden (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Ana M Aldea Perona, MD, PhD (1) · Cristobal Passalacqua, MD (1) · Francesco Bibbiani, MD (1) · Jie Ding, Prof. (1) · Joanne Donovan, MD, PhD (1) · Kate Bushby, MD (1) · Katherine Smith, MD (1) · Maggie C. Walter, MD (1) · Robert C. Griggs, MD (1) · Rosa Ventura Alemany, PharmD, PhD (1) · Talita D da Silva, Ph.D. (1) · Uma Arumugam, MD (1)
PMID 23406536, PMID 34857536, PMID 35381069, PMID 42139655, PMID 42202243, PMID 42249273, PMID 42443978
U01NS061799 (1)