6 completed, 1 not yet recruiting. 7 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 6, Not yet recruiting 1 |
| Phase 1 | 1 | Completed 1 |
Follow brexanolone: new trials by email Literature Review of brexanolone trials Research Report on brexanolone
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 |
|---|---|---|---|---|---|---|
| Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study Brexanolone - Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD) | Phase 2 | Not yet recruiting | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | 40 | 2027-01-15 | 2026-09-21 |
| An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus Brexanolone - Tinnitus | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 10 | 2023-05-10 | 2025-09-15 |
| A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression SAGE-547, Placebo - Severe Postpartum Depression | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 21 | 2015-12-15 | 2025-09-15 |
| Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone Allopregnanolone - Fragile X-associated Tremor/Ataxia Syndrome | Phase 2 | Completed | Randi J. Hagerman, MD | 6 | 2015-10-01 | 2018-12-06 |
| Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression SAGE-547 - Postpartum Depression | Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 4 | 2015-01-07 | 2025-09-15 |
| Evaluate SAGE-547 in Participants With Essential Tremor SAGE-547, Placebo - Essential Tremor | Phase 2 | Completed | Sage Therapeutics | 25 | 2014-09-23 | 2022-06-29 |
| Study to Evaluate SAGE-547 Injection as Adjunctive Therapy for the Treatment of Super-Refractory Status Epilepticus SAGE-547 - Super-refractory Status Epilepticus | Phase 1 / Phase 2 | Completed | Supernus Pharmaceuticals, Inc. | 25 | 2014-03-21 | 2025-09-15 |
Depression, Postpartum (2) · Alcohol Drinking (1) · Alcoholism (1) · Essential Tremor (1) · Fragile X Tremor Ataxia Syndrome (1) · Status Epilepticus (1) · Stress Disorders, Post-Traumatic (1) · Tinnitus (1)
Supernus Pharmaceuticals, Inc. (4) · Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (1) · Randi J. Hagerman, MD (1) · Sage Therapeutics (1)
United States (6)
Robert Lasser, MD, MBA (2) · Stephen J Kanes, MD, PhD (2) · MacKenzie R. Peltier, Ph.D. (1) · Randi J Hagerman, MD (1)