17 completed, 3 terminated, 2 not yet recruiting, 2 withdrawn. 15 Phase 2, 8 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 12, Not yet recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 3 | 8 | Completed 4, Terminated 2, Not yet recruiting 1, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
Follow ganaxolone: new trials by email Literature Review of ganaxolone trials Research Report on ganaxolone
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 |
|---|---|---|---|---|---|---|
| Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old Ganaxolone, Placebo - CDKL5 Deficiency Disorder | Phase 3 | Not yet recruiting | Immedica Pharma AB | 20 | 2027-03-01 | 2026-08-05 |
| Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism Ganaxolone (Ztalmy), Placebo - Autism in Children, Autistic Disorder in Children and Adolescents | Phase 2 | Not yet recruiting | Stanford University | 66 | 2027-01-01 | 2026-06-09 |
| 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Refractory Status Epilepticus (RSE) Ganaxolone, Placebo, Standard of care - Refractory Status Epilepticus | Phase 3 | Withdrawn | Marinus Pharmaceuticals | 2024-03-01 | 2024-05-14 | |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as Adjuvant Therapy for Established Status Epilepticus (ESE) IV Ganaxolone, IV Placebo - Status Epilepticus | Phase 2 | Withdrawn | Marinus Pharmaceuticals | 2023-04-01 | 2024-05-07 | |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 |
| 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 |
| Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone Ganaxolone - Major Depressive Disorder | Not applicable | Completed | Massachusetts General Hospital | 10 | 2016-11-01 | 2019-02-18 |
| 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 |
| Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate Ganaxolone, Nicotine Patch - Smoking Cessation | Phase 2 | Completed | Jed E. Rose | 36 | 2013-06-01 | 2014-09-08 |
| 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 |
Showing 20 of 25. Sign in to see all of them.
Epilepsy (8) · Seizures (8) · Epilepsies, Partial (4) · CDKL5 deficiency disorder (3) · Depression (3) · Status Epilepticus (3) · Tuberous Sclerosis (3) · Behavioral Symptoms (2) · Depression, Postpartum (2) · Depressive Disorder (2) · Mental Disorders (2) · Mood Disorders (2) · Pregnancy Complications (2) · Puerperal Disorders (2) · Spasms, Infantile (2)
Marinus Pharmaceuticals (21) · Immedica Pharma AB (1) · Jed E. Rose (1) · Massachusetts General Hospital (1) · Stanford University (1)
United States (21) · 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) · Antonio Y. Hardan, M.D. (1) · Christine E Marx, MD, MA (1) · Igor Grachev, MD, PhD (1) · Jed E Rose, Ph.D. (1) · Karen K Miller, MD (1) · Maciej Gasior, M.D., Ph.D (1) · Paula Bokesch, MD, FAAP (1) · Paula Bokesk, M.D., FAAP (1)
PMID 36517284, PMID 28667510, PMID 28764646, PMID 32558402, PMID 34528245, PMID 35429480, PMID 36870093
2018 (2), P50DA027840 (1)