6 completed, 3 no longer available, 1 approved for marketing, 1 not yet recruiting. 2 Phase 1, 2 Phase 4, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Not yet recruiting 1 |
Follow stiripentol: new trials by email Literature Review of stiripentol trials Research Report on stiripentol
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 |
|---|---|---|---|---|---|---|
| Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ) Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®) - Dravet Syndrome, Epilepsy | Phase 1 | Completed | Biocodex | 24 | 2025-06-01 | 2025-09-16 |
| Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3 Stiripentol Oral Capsule, Placebo Oral Capsule, Urine samples collect - Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2 | Phase 3 | Not yet recruiting | Biocodex | 42 | 2024-08-01 | 2024-06-18 |
| Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies Stiripentol - Pharmacoresistant Focal Epilepsies | Phase 4 | Completed | Biocodex | 52 | 2022-10-13 | 2024-07-24 |
| Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria stiripentol (Diacomit) - Primary Hyperoxaluria | Phase 2 | Completed | Biocodex | 15 | 2019-05-21 | 2021-03-26 |
| Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers Stiripentol - Healthy Volunteers | Phase 1 | Completed | Biocodex | 14 | 2019-02-12 | 2019-12-20 |
| Population Pharmacokinetics of Antiepileptic in Pediatrics Valproic acid, carbamazepine, phenobarbital - Epilepsy | Completed | Assistance Publique - Hôpitaux de Paris | 753 | 2017-06-19 | 2025-11-20 | |
| Ketogenic Diet in Infants With Epilepsy (KIWE) Ketogenic diet, Antiepileptic drug therapy - Epilepsy | Phase 4 | Unknown | University College, London | 160 | 2015-01-01 | 2017-05-04 |
| Stiripentol for the Treatment of Refractory Status Epilepticus Stiripentol - Status Epilepticus | Completed | University Hospital Marburg | 25 | 2013-01-01 | 2024-08-06 | |
| Stiripentol in Dravet Syndrome stiripentol - Dravet Syndrome | No longer available | Mayo Clinic | 2012-02-01 | 2013-02-28 | ||
| Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies Stiripentol - Dravet Syndrome, Epileptic Encephalopathies Associated With SCN1A Mutations | No longer available | Cook Children's Health Care System | 2020-02-05 | |||
| Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome Stiripentol - Dravet Syndrome | Approved for marketing | Children's Hospital Medical Center, Cincinnati | 2026-01-23 | |||
| Compassionate Use of Stiripentol in Dravet Syndrome Stiripentol - Dravet Syndrome | No longer available | University of Colorado, Denver | 2019-10-04 |
Epilepsies, Myoclonic (5) · Epilepsy (5) · Hyperoxaluria, Primary (2) · Primary hyperoxaluria type 1 (1) · Primary hyperoxaluria type 2 (1) · Status Epilepticus (1)
Biocodex (5) · Assistance Publique - Hôpitaux de Paris (1) · Children's Hospital Medical Center, Cincinnati (1) · Cook Children's Health Care System (1) · Mayo Clinic (1) · University College, London (1) · University Hospital Marburg (1) · University of Colorado, Denver (1)
France (4) · United States (4) · Belgium (1) · United Kingdom (1)
Elaine Wirrell, MD (1) · Helen Cross, FRCP(UK) (1) · Kelly Knupp, MD (1) · Scott Perry, MD (1)
2023 (1)