CLINICAL TRIALS PROFILE FOR BREXANOLONE

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Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)	Withdrawn	Sage Therapeutics	Phase 4	2020-02-01	In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of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.

Clinical Trial Conditions for BREXANOLONE

Condition Name

Condition Name for BREXANOLONE
Intervention	Trials
Postpartum Depression	3
PTSD	1
Tinnitus	1
Acute Respiratory Distress Syndrome	1

Condition MeSH

Condition MeSH for BREXANOLONE
Intervention	Trials
Depression, Postpartum	4
Depressive Disorder	3
Depression	3
Syndrome	2

Clinical Trial Locations for BREXANOLONE

Trials by Country

Trials by Country for BREXANOLONE
Location	Trials
United States	23
Australia	1

Trials by US State

Trials by US State for BREXANOLONE
Location	Trials
California	3
North Carolina	3
Georgia	2
Arizona	1
Connecticut	1

Clinical Trial Progress for BREXANOLONE

Clinical Trial Phase

Clinical Trial Phase for BREXANOLONE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for BREXANOLONE
Clinical Trial Phase	Trials
Not yet recruiting	6
Completed	2
Recruiting	1

Clinical Trial Sponsors for BREXANOLONE

Sponsor Name

Sponsor Name for BREXANOLONE
Sponsor	Trials
Sage Therapeutics	8
Donald Jeffrey Newport	1
University of North Carolina, Chapel Hill	1

Sponsor Type

Sponsor Type for BREXANOLONE
Sponsor	Trials
Industry	9
Other	6
NIH	1