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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tinnitus

Intervention / Treatment
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* Drug: incobotulinum toxin A
* Drug: Placebo-Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |