NCT05645432Phase 2Completed

An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

Study sponsor: Supernus Pharmaceuticals, Inc. · SUPN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-21Actual

Enrollment · participants10Actual

Source updated2025-09-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Tinnitus

Treatments or interventions studied

BrexanoloneDrugAlso known as Allopregnanolone, ZULRESSO®, SAGE-547

Primary outcomes · main study measures

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measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE); description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset after the start of brexanolone, or any worsening of a pre-existing medical condition/adverse event with onset after the start of brexanolone and throughout the study.; timeFrame: Up to Day 15

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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