Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-07 @ 8:26 PM
Study NCT ID:
NCT05645432
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Sponsor:
Supernus Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: