Xeomin Injections for Tinnitus

Recruiting in Palo Alto (17 mi)

Overseen ByStephanie Standal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Minnesota

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing Xeomin injections to help people with tinnitus, a condition that causes persistent ringing in the ears. Xeomin is a type of botulinum toxin that, when injected into ear muscles, may reduce the ringing by relaxing these muscles. The effectiveness will be measured using a questionnaire. Xeomin has been explored in various studies for its potential to treat tinnitus by relaxing ear muscles.

Eligibility Criteria

This trial is for adults over 18 with tinnitus (ringing in the ears) lasting more than 2 months and a significant impact on their life, as measured by a score above 16 on the Tinnitus Handicap Inventory. It's not for those allergic to botulinum toxin, who've had botulinum injections within 4 months, have an infection at the injection site, upcoming ear-related surgeries, major psychiatric conditions or are pregnant/breastfeeding.

Inclusion Criteria

I am 18 years old or older.

You have a Tinnitus Handicap Inventory score higher than 16.

I have had ringing in one or both ears for at least 2 months.

+1 more

Exclusion Criteria

I have an infection where I might get injections.

You have a history of serious mental health issues or have been diagnosed with major depression.

I am scheduled for surgery related to chronic ear issues or certain brain tumors.

+3 more

Participant Groups

The study tests if Xeomin (incobotulinumtoxinA) injections into ear muscles can relieve tinnitus. Participants will either receive this treatment or a placebo-saline solution. The effectiveness is measured using patient responses to the Tinnitus Handicap Inventory questionnaire.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Incobotulinium toxin A groupExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Individuals with symptoms of tetanus will receive placebo saline injections.