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NCT05645432 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
A Phase 2 study, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT05645432: Completed Phase 2 study, sponsored by Supernus Pharmaceuticals.
NCT05645432 is a Phase 2 study that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05645432, a Phase 2 study, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Brexanolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-10 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 2 |
What the finished NCT05645432 record still lists
NCT05645432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexanolone is the first listed.
NCT05645432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05645432 about?
NCT05645432 is a clinical study titled "An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus". 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.
What is the current status of trial NCT05645432?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2023-05-10. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT05645432?
The interventions under investigation include: Brexanolone (DRUG).
Who is sponsoring clinical trial NCT05645432?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05645432's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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