The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults age 18 or older
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Unilateral or bilateral tinnitus present for ≥ 2 months
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A score >16 on the Tinnitus Handicap Inventory
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Participants must be willing and able to provide informed consent.
Exclusion Criteria:
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Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
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Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening.
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Patients with infection at proposed injection sites.
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Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors.
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Significant psychiatric history or associated diagnosis of major depression.
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Women who are pregnant or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Stephanie Standal, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HRP-