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

NCT05650645 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-02-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Stephanie Standal, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-29
Completion
2025-12-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650645 on ClinicalTrials.gov