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Can a botox shot silence tinnitus? small trial hints at possibility

NCT ID NCT05650645

Symptom relief Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether injections of incobotulinum toxin A (similar to Botox) into muscles around the ear can relieve tinnitus, a persistent ringing in the ears. Forty-one adults with tinnitus for at least two months received either the drug or a placebo injection. The main goal was to see if the treatment improved scores on a standard tinnitus questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
incobotulinum toxin A (Xeomin)
What this could lead to
If it works, this could point toward a new treatment option for people with persistent ringing in the ears.
What could go wrong
This is a small, early-stage trial with only 41 participants. The treatment may not reduce tinnitus symptoms more than a placebo, and there are risks like injection site reactions or muscle weakness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults age 18 or older * Unilateral or bilateral tinnitus present for ≥ 2 months * A score \>16 on the Tinnitus Handicap Inventory * Participants must be willing and able to provide informed consent. Exclusion Criteria: * Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation. * Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening. * Patients with infection at proposed injection sites. * Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors. * Significant psychiatric history or associated diagnosis of major depression. * Women who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

tinnitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tinnitus

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.