The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial

Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Incobotulinum Toxin A

Drug

The study intervention is a syringe of 50 units of incobotulinum toxin A total, with 25 units per side, a total of 6 injection sites incobotulinum toxin A diluted into 1 ml of normal saline, injected in equal amounts into the anterior, superior, and posterior auricular muscles using anatomical landmarks. This will be approximately 0.16 mL (8-9 units) of the combined solution per injection site.

Placebo-Saline

Drug

Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.

Primary outcomes

Change in the Tinnitus Handicap Inventory score

Time frame: pre-injection baseline to 4-6 weeks post injection

in the group assigned to placebo for the first stage

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 14, 2022
Registry last updated: Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed