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

Phase 2

Active, not recruiting

• Conditions: Tinnitus
• Interventions: Drug: incobotulinum toxin A; Drug: Placebo-Saline

• Registration Number: NCT05650645
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Study Start: 2023-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-05-29
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incobotulinium toxin A group	incobotulinum toxin A	Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.
Placebo	Placebo-Saline	Individuals with symptoms of tetanus will receive placebo saline injections.

Primary Outcome Measures

Name	Time	Method
Change in the Tinnitus Handicap Inventory score	pre-injection baseline to 4-6 weeks post injection	in the group assigned to placebo for the first stage

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States