CLINICAL TRIALS PROFILE FOR BREXANOLONE
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All Clinical Trials for BREXANOLONE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02603926 ↗ | Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone | Completed | Randi J. Hagerman, MD | Phase 2 | 2015-10-01 | The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS). |
| NCT02603926 ↗ | Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone | Completed | University of California, Davis | Phase 2 | 2015-10-01 | The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS). |
| NCT03665038 ↗ | A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) | Completed | Sage Therapeutics | Phase 3 | 2018-05-17 | This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression. |
| NCT04273191 ↗ | A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone) | Withdrawn | Sage Therapeutics | Phase 4 | 2020-02-01 | In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters. |
| NCT04537806 ↗ | A Study of Brexanolone for Acute Respiratory Distress Syndrome Due to COVID-19 | Terminated | Sage Therapeutics | Phase 3 | 2020-12-18 | The purpose of this study is to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19. |
| NCT05059600 ↗ | A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting | Not yet recruiting | Sage Therapeutics | Phase 4 | 2021-11-01 | The primary purpose of this study is to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting. |
| NCT05223829 ↗ | Utility of Brexanolone to Target Stress-induced Alcohol Use Among Men and Women With Posttraumatic Stress Disorder | Not yet recruiting | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 1 | 2022-03-01 | For this protocol, the investigators plan to collect pilot data to: 1. establish the feasibility and safety of administering brexanolone to individuals with concurrent Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for BREXANOLONE
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Clinical Trial Locations for BREXANOLONE
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Clinical Trial Progress for BREXANOLONE
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Clinical Trial Sponsors for BREXANOLONE
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