4 completed, 2 terminated, 1 withdrawn. 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 4, Terminated 2, Withdrawn 1 |
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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 |
|---|---|---|---|---|---|---|
| To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE) Ganaxolone, Placebo, Standard of care - Refractory Status Epilepticus | Phase 3 | Withdrawn | Marinus Pharmaceuticals | 2024-03-01 | 2024-05-14 | |
| Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy Ganaxolone - Tuberous Sclerosis Complex | Phase 3 | Terminated | Marinus Pharmaceuticals | 117 | 2022-05-16 | 2025-10-01 |
| Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy Ganaxolone, Placebo - Tuberous Sclerosis Complex | Phase 3 | Completed | Marinus Pharmaceuticals | 129 | 2022-04-01 | 2025-07-11 |
| Randomized Therapy In Status Epilepticus Ganaxolone, Placebo - Status Epilepticus | Phase 3 | Completed | Marinus Pharmaceuticals | 100 | 2020-12-09 | 2025-05-29 |
| Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder ganaxolone, Placebo - CDKL5 Deficiency Disorder | Phase 3 | Completed | Marinus Pharmaceuticals | 101 | 2018-06-30 | 2023-04-14 |
| A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures ganaxolone - Drug Resistant Partial Onset Seizure | Phase 3 | Terminated | Marinus Pharmaceuticals | 26 | 2015-02-01 | 2023-06-28 |
| Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension ganaxolone, Placebo - Drug Resistant Partial Onset Seizure | Phase 3 | Completed | Marinus Pharmaceuticals | 405 | 2013-10-01 | 2023-02-14 |
Epilepsy (4) · Seizures (4) · Epilepsies, Partial (2) · Status Epilepticus (2) · Tuberous Sclerosis (2) · CDKL5 deficiency disorder (1)
ganaxolone (7) · Standard of Care (1)
United States (6) · Australia (5) · France (4) · Germany (4) · Israel (4) · Italy (4) · United Kingdom (4) · Canada (3) · Poland (3) · Spain (3) · China (2) · Russia (2) · Austria (1) · Belgium (1) · Bulgaria (1)
2018 (1)