5 completed, 3 terminated, 1 active not recruiting, 1 not yet recruiting. 4 Phase 2, 3 Phase 1, 2 Phase 4, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 2, Active not recruiting 1, Not yet recruiting 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 4 | 2 | Completed 1, Terminated 1 |
| Phase 3 | 1 | Terminated 1 |
Follow Allopregnanolone: new trials by email Literature Review of Allopregnanolone trials Research Report on Allopregnanolone
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 |
|---|---|---|---|---|---|---|
| Allopregnanolone in Chronic Complex Traumatic Brain Injury Placebo, Allopregnanolone - Traumatic Brain Injury (TBI) | Phase 2 | Not yet recruiting | VA Office of Research and Development | 132 | 2026-12-01 | 2026-10-19 |
| Allopregnanolone as a Regenerative Treatment for Parkinson's Disease Allopregnanolone - Parkinson Disease | Phase 1 | Completed | Roberta Brinton | 10 | 2024-01-12 | 2026-03-13 |
| Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease Allopregnanolone, Placebo - Alzheimer Dementia, Late Onset Alzheimer Disease | Phase 2 | Active not recruiting | University of Arizona | 100 | 2023-08-15 | 2026-06-30 |
| 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 |
| Study on Allopregnanolone and Depression in Perimenopausal Women brexanolone, placebo - Depression | Phase 4 | Terminated | Brigham and Women's Hospital | 2 | 2022-11-04 | 2026-01-22 |
| A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting ZULRESSO® - Postpartum Depression | Phase 4 | Completed | Supernus Pharmaceuticals, Inc. | 52 | 2021-10-08 | 2025-09-15 |
| A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19) Brexanolone, Placebo - Acute Respiratory Distress Syndrome, COVID-19 | Phase 3 | Terminated | Sage Therapeutics | 29 | 2020-12-18 | 2022-08-19 |
| Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study Allopregnanolone - Alzheimer Dementia | Phase 1 | Terminated | University of Arizona | 6 | 2019-10-01 | 2026-03-13 |
| Effect of Allopregnanolone on Stress-induced Craving Allopregnanolone, Placebos - Alcohol Use Disorder | Phase 1 | Completed | Yale University | 10 | 2019-07-01 | 2025-08-22 |
| 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 |
Alzheimer Disease (2) · Depression (2) · Alcoholism (1) · Brain Injuries, Traumatic (1) · COVID-19 (1) · Cognitive Dysfunction (1) · Dementia (1) · Depression, Postpartum (1) · Fragile X Tremor Ataxia Syndrome (1) · Neurodegenerative Diseases (1) · Pain (1) · Parkinson Disease (1) · Respiratory Distress Syndrome (1) · Tinnitus (1)
Supernus Pharmaceuticals, Inc. (2) · University of Arizona (2) · Brigham and Women's Hospital (1) · Randi J. Hagerman, MD (1) · Roberta Brinton (1) · Sage Therapeutics (1) · VA Office of Research and Development (1) · Yale University (1)
United States (10)
Roberta D Brinton, PhD (3) · Gerson D Hernandez, MD, MPH (2) · Christine E. Marx, MD MA (1) · Elizabeth Ralevski, PhD (1) · Lon S Schneider, MD, MS (1) · Lon Schneider, MD (1) · Randi J Hagerman, MD (1) · Scott Sherman, MD (1)
I01RX002798 (1), R01AG063826 (1), R21AA024917 (1)