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

NCT05650645 | Completed Phase 2 FDA Drug

• 1 other identifier: PMR-2021-29462
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in the Tinnitus Handicap Inventory score

  in the group assigned to placebo for the first stage

  pre-injection baseline to 4-6 weeks post injection

Study Arms (2)

Incobotulinium toxin A group

EXPERIMENTAL

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

Drug: incobotulinum toxin A

Placebo

PLACEBO COMPARATOR

Individuals with symptoms of tetanus will receive placebo saline injections.

Drug: Placebo-Saline

Interventions

Placebo-Saline DRUG

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

Placebo

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.

Incobotulinium toxin A group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephanie Standal, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 1, 2023
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)