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GABA receptor modulator

Brexanolone for Tinnitus

Phase 2
Waitlist Available
Research Sponsored by Sage Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a diagnosis of subjective, idiopathic, unilateral or bilateral, non-pulsatile tinnitus of ≥6 months and <10 years duration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to approximately 6 days from day 2 to day 7 after ip infusion given on day 1
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe and tolerable for people with tinnitus, given in a single 6-hour IV infusion.

Who is the study for?
Adults with tinnitus for 6 months to less than 10 years, experiencing mild to severe distress but in good physical health. They must not have significant medical conditions or allergies related to the treatment, and be able to stop certain medications before and during the trial. A companion is required for clinic visits.Check my eligibility
What is being tested?
The safety and tolerability of a single continuous intravenous infusion of brexanolone over 6 hours are being tested on adults with tinnitus to see if it can help reduce their symptoms.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to brexanolone infusion which could include typical IV medication risks such as irritation at the injection site, allergic reactions, or systemic effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing ringing in your ears for at least 6 months but less than 10 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to approximately 6 days from day 2 to day 7 after ip infusion given on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to approximately 6 days from day 2 to day 7 after ip infusion given on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Secondary outcome measures
Change From Baseline to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change From Baseline to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change From Baseline to Post-infusion in VAS-A Ratings Measured via Daily Diary Over Multiple Days
+1 more

Side effects data

From 2021 Phase 3 trial • 28 Patients • NCT03665038
25%
Infusion site pain
13%
Nausea
13%
Upper respiratory tract infection
13%
Sedation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Phase: Placebo
Double-Blind Phase: Brexanolone
Open-Label Phase: Brexanolone

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrexanoloneExperimental Treatment1 Intervention
Participants will receive a continuous, 6-hour IV infusion of Brexanolone on Day 1 of the Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexanolone
2018
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

Sage TherapeuticsLead Sponsor
49 Previous Clinical Trials
11,751 Total Patients Enrolled

Media Library

Brexanolone (GABA receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05645432 — Phase 2
Tinnitus Research Study Groups: Brexanolone
Tinnitus Clinical Trial 2023: Brexanolone Highlights & Side Effects. Trial Name: NCT05645432 — Phase 2
Brexanolone (GABA receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645432 — Phase 2
Tinnitus Patient Testimony for trial: Trial Name: NCT05645432 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors able to join this experiment?

"This study seeks volunteers of legal age, that is to say those older than 18 and younger than 65."

Answered by AI

Are enrollees currently being accepted for this research program?

"This clinical trial, which was initially opened for recruitment on May 10th 2023 and recently updated on the 15th of May, is still recruiting patients."

Answered by AI

How many participants are being enrolled in this research endeavor?

"Affirmative. The clinical trial is still recruiting, as evidenced by the information on clinicaltrials.gov which shows it was first posted on May 10th 2023 and last updated 15 days later. 24 individuals are expected to partake from a single site."

Answered by AI

What is the current regulatory status of Brexanolone?

"There is some evidence of Brexanolone's safety, so it was assigned a 2 on our rating scale. However, there are no current studies that demonstrate its effectiveness for this treatment."

Answered by AI

Who has the prerequisites to be admitted into this trial?

"This clinical trial is recruiting 24 individuals with tinnitus between the legal age of consent to 65 years old. To qualify for this study, participants must have a companion driver on the day they visit the clinic, be in good physical health (excluding tinnitus), and possess non-pulsatile idiopathic unilateral or bilateral subjective tinnitus lasting 6 months to 5 years. Furthermore, those who are accepted should exhibit mild to severe distress regarding their condition according to Tinnitus Handicap Inventory scores from 24 - 68 at screening and agree not to take any CNS depressants such as opioids & benzodiazepines, antidepressants"

Answered by AI

Who else is applying?

What site did they apply to?
Sage Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
What state do they live in?
Florida
California

Why did patients apply to this trial?

I have tried Lenire and it didn’t work so far.
PatientReceived 2+ prior treatments
~5 spots leftby Mar 2025