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

February 5, 2026 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incobotulinium toxin A group
Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.
Drug: 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.
Placebo Comparator: Placebo
Individuals with symptoms of tetanus will receive placebo saline injections.
Drug: Placebo-Saline
Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-injection baseline to 4-6 weeks post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Stephanie Standal, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

December 29, 2025

Study Completion (Actual)

December 29, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR-2021-29462

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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