What is the mechanism of action of this treatment?

Common treatments for tinnitus include cognitive behavioral therapy (CBT), sound therapy, and pharmacological treatments. Brexanolone, a GABA-A receptor modulator, is being studied for its potential to alleviate tinnitus symptoms by enhancing inhibitory neurotransmission in the brain. This is significant for tinnitus patients because it targets the neural hyperactivity believed to contribute to tinnitus perception. Understanding these mechanisms helps patients and clinicians make informed decisions about treatment options that may effectively reduce the distress and impact of tinnitus on daily life.

What side effects are associated with this type of intervention?

Common treatments for tinnitus that are similar to Brexanolone, a GABA-A receptor modulator, include medications like benzodiazepines and anticonvulsants. Known side effects of these treatments can include dizziness, drowsiness, confusion, and potential dependency with long-term use. Other side effects may include headache, nausea, and in some cases, cognitive impairment. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of tinnitus. Brexanolone, a GABA-A receptor modulator, is being studied for its potential benefits in tinnitus, but it has not yet received FDA approval for this indication. Current treatments for tinnitus often focus on managing symptoms through various approaches such as cognitive behavioral therapy, sound therapy, and sometimes off-label use of medications like antidepressants and anticonvulsants.

What other types of research exist?

Promising novel alternatives to Brexanolone for tinnitus treatment in 2024 include neuromodulation techniques such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS). Additionally, research into other pharmacological agents like NMDA receptor antagonists and potassium channel modulators is ongoing and may offer new treatment options.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called brexanolone to see if it is safe for people who have tinnitus, a condition where they hear ringing in their ears.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Secondary study objectives

Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings

Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings

Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days

+5 more

Side effects data

From 2021 Phase 3 trial • 28 Patients • NCT03665038

25%

Infusion site pain

13%

Sedation

13%

Nausea

13%

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Double-Blind Phase: Placebo

Double-Blind Phase: Brexanolone

Open-Label Phase: Brexanolone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BrexanoloneExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brexanolone

2018

Completed Phase 3

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus include cognitive behavioral therapy (CBT), sound therapy, and pharmacological treatments. Brexanolone, a GABA-A receptor modulator, is being studied for its potential to alleviate tinnitus symptoms by enhancing inhibitory neurotransmission in the brain. This is significant for tinnitus patients because it targets the neural hyperactivity believed to contribute to tinnitus perception. Understanding these mechanisms helps patients and clinicians make informed decisions about treatment options that may effectively reduce the distress and impact of tinnitus on daily life.