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

NCT ID: NCT05650645

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-29

Brief Summary

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Incobotulinium toxin A group

Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.

Group Type: EXPERIMENTAL

incobotulinum toxin A

Intervention Type: 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

Individuals with symptoms of tetanus will receive placebo saline injections.

Group Type: PLACEBO_COMPARATOR

Placebo-Saline

Intervention Type: DRUG

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

Interventions

incobotulinum toxin A

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.

Intervention Type: DRUG

Placebo-Saline

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Standal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PMR-2021-29462

Identifier Type: -

Identifier Source: org_study_id