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

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650645
• Other study ID #: HRP-
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Stephanie Standal, MD
• Phone: (612)625-2661
• Email: stan0621[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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-Saline
Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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