CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Brexanolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05645432
NCT05645432Phase 2Completed
CompareCT.gov

An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus

Supernus Pharmaceuticals, Inc.·interventional·Posted Dec 9, 2022·Updated Sep 15, 2025

In Brief

A Phase 2 clinical trial evaluating Brexanolone for Tinnitus. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of brexanolone in participants with tinnitus following a single 6-hour continuous intravenous (IV) infusion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedDec 9, 2022
Enrollment StartMay 10, 2023
Primary CompletionNov 21, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.6 years ago

Interventions

Brexanolonedrug

Brexanolone IV infusion