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

University of Minnesota (UMN)

Status and phase: Active, not recruiting; Phase 2

Conditions: Tinnitus

Treatments: Drug: incobotulinum toxin A; Drug: Placebo-Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05650645

HRP-

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups, including a placebo group

Incobotulinium toxin A group

Experimental group

Description:

Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.

Treatment:

Drug: incobotulinum toxin A

Placebo

Placebo Comparator group

Description:

Individuals with symptoms of tetanus will receive placebo saline injections.

Treatment:

Drug: Placebo-Saline