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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

December 29, 2025

Study Completion Date

December 29, 2025

Conditions
Tinnitus
Interventions
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.

DRUG

Placebo-Saline

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

Trial Locations (1)

55455

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER