16 completed, 3 terminated, 2 withdrawn, 1 no longer available. 14 Phase 2, 7 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 12, Terminated 1, Withdrawn 1 |
| Phase 3 | 7 | Completed 4, Terminated 2, Withdrawn 1 |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Refractory Status Epilepticus (RSE) Ganaxolone, Placebo, Standard of care - Refractory Status Epilepticus | Phase 3 | Withdrawn | Marinus Pharmaceuticals | 2024-03-01 | 2024-05-14 | |
| Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE) IV Ganaxolone, IV Placebo - Status Epilepticus | Phase 2 | Withdrawn | Marinus Pharmaceuticals | 2023-04-01 | 2024-05-07 | |
| 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 |
| Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) Ganaxolone - Tuberous Sclerosis | Phase 2 | Completed | Marinus Pharmaceuticals | 23 | 2020-04-08 | 2023-04-04 |
| Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study) Ganaxolone, Placebo - PCDH19-Related Epilepsy | Phase 2 | Completed | Marinus Pharmaceuticals | 29 | 2019-05-17 | 2023-06-26 |
| 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 |
| Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus IV Ganaxolone active, IV Placebo, non-active - Status Epilepticus, Convulsive Status EPILEPTICUS | Phase 2 | Completed | Marinus Pharmaceuticals | 17 | 2018-02-19 | 2023-03-09 |
| A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression Ganaxolone, Placebo - Depressive Disorder, Depression | Phase 2 | Completed | Marinus Pharmaceuticals | 84 | 2017-12-28 | 2023-08-18 |
| A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression Ganaxolone, Placebo - Depression, Depressive Disorder | Phase 2 | Completed | Marinus Pharmaceuticals | 91 | 2017-06-27 | 2023-07-19 |
| Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies Ganaxolone - Epilepsy | Phase 2 | Completed | Marinus Pharmaceuticals | 30 | 2015-11-06 | 2023-03-21 |
| 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 |
| Ganaxolone Treatment in Children With Fragile X Syndrome Ganaxolone, Placebo - Fragile x Syndrome | Phase 2 | Completed | Marinus Pharmaceuticals | 59 | 2012-11-01 | 2023-04-10 |
| Ganaxolone in Posttraumatic Stress Disorder (PTSD) Ganaxolone, Placebo - PTSD | Phase 2 | Completed | Marinus Pharmaceuticals | 112 | 2011-04-01 | 2022-12-29 |
| A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601 ganaxolone - Epilepsy, Complex Partial | Phase 2 | Completed | Marinus Pharmaceuticals | 11 | 2009-10-01 | 2022-09-07 |
| Open-label Extension to Protocol 1042-0600 ganaxolone - Epilepsies, Partial | Phase 2 | Completed | Marinus Pharmaceuticals | 123 | 2007-06-01 | 2023-01-17 |
| A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures Ganaxolone, Placebo - Partial Epilepsy, Catamenial Epilepsy | Phase 2 | Completed | Marinus Pharmaceuticals | 147 | 2007-02-01 | 2023-03-15 |
| Open-label Extension to Protocol 1042-0500 Ganaxolone - Infantile Spasms | Phase 2 | Terminated | Marinus Pharmaceuticals | 54 | 2007-01-01 | 2024-05-28 |
Showing 20 of 22. Sign in to see all of them.
Epilepsy (9) · Seizures (8) · Epilepsies, Partial (4) · Status Epilepticus (4) · Tuberous Sclerosis (3) · Behavioral Symptoms (2) · CDKL5 deficiency disorder (2) · Depression (2) · Depression, Postpartum (2) · Depressive Disorder (2) · Mental Disorders (2) · Mood Disorders (2) · Pregnancy Complications (2) · Puerperal Disorders (2) · Spasms, Infantile (2)
ganaxolone (21) · Standard of Care (1)
United States (19) · Italy (6) · Australia (5) · France (4) · Germany (4) · Israel (4) · Poland (4) · United Kingdom (4) · Canada (3) · Spain (3) · Belgium (2) · China (2) · Hungary (2) · Russia (2) · Austria (1)
Joseph Hulihan, MD (2) · Ann Rasmusson, MD (1) · Christine E Marx, MD, MA (1) · Igor Grachev, MD, PhD (1) · Maciej Gasior, M.D., Ph.D (1) · Maciej Gasior, MD, PhD (1) · Paula Bokesch, MD, FAAP (1) · Paula Bokesk, M.D., FAAP (1)
PMID 28667510, PMID 28764646, PMID 34528245, PMID 35429480, PMID 35748707, PMID 36517284, PMID 36870093
2018 (2)