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

Last updated: April 15, 2025
Sponsor: University of Minnesota
Overall Status: Active - Not Recruiting

Phase

2

Condition

Tinnitus

Treatment

Placebo-Saline

incobotulinum toxin A

Clinical Study ID

NCT05650645
HRP-
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with known hypersensitivity to any botulinum toxin product or to any of thecomponents 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 Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Placebo-Saline
Phase: 2
Study Start date:
January 01, 2023
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

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