Trials / Completed
CompletedNCT05645432
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brexanolone | Brexanolone IV infusion |
Timeline
- Start date
- 2023-05-10
- Primary completion
- 2023-11-21
- Completion
- 2023-11-21
- First posted
- 2022-12-09
- Last updated
- 2025-09-15
- Results posted
- 2024-12-12
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05645432. Inclusion in this directory is not an endorsement.