An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT05645432
Phase
PHASE2
Status
Completed

Conditions

  • Tinnitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 10, 2023
Status verified
Nov 2024
Primary completion
Nov 21, 2023
Completion
Nov 21, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brexanolone
    Participants will receive a 6-hour single continuous intravenous (IV) infusion of brexanolone at 30 micrograms per kilogram per hour (mcg/kg/hour) for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to Day 15 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Sage Investigational SiteAtlantaGeorgia30331-
Sage Investigational SiteIowa CityIowa52242-

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