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Neurotoxin

Xeomin Injections for Tinnitus

Phase 2
Recruiting
Led By Stephanie Standal, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral or bilateral tinnitus present for ≥ 2 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-injection baseline to 4-6 weeks post injection
Awards & highlights

Study Summary

This trial is studying if Xeomin injections can help reduce symptoms of tinnitus, a ringing in the ear that affects up to 20% of Americans.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of incobotulinum toxin A include pain at the injection site, muscle weakness near where it was injected, flu-like symptoms and rarely spread of toxin effects causing breathing difficulties and swallowing issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had ringing in one or both ears for at least 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-injection baseline to 4-6 weeks post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-injection baseline to 4-6 weeks post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Tinnitus Handicap Inventory score

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,387 Previous Clinical Trials
1,552,470 Total Patients Enrolled
3 Trials studying Tinnitus
46 Patients Enrolled for Tinnitus
Stephanie Standal, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

incobotulinum toxin A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05650645 — Phase 2
Tinnitus Research Study Groups: Incobotulinium toxin A group, Placebo
Tinnitus Clinical Trial 2023: incobotulinum toxin A Highlights & Side Effects. Trial Name: NCT05650645 — Phase 2
incobotulinum toxin A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650645 — Phase 2
Tinnitus Patient Testimony for trial: Trial Name: NCT05650645 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its sanction to Incobotulinium toxin A for medical use?

"Our team assessed the safety of Incobotulinium toxin A group to be a 2 due to its Phase 2 status. This indicates that while there is some evidence supporting it being safe, no data exists suggesting efficacy."

Answered by AI

Is this investigative study available for participants to join at present?

"According to clinicaltrials.gov, this experiment is not presently open for participants as the last update was on December 6th 2022. Nevertheless, there are 53 other medical trials actively recruiting patients at this moment in time."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Iowa
Other
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
University of Minnesota

Why did patients apply to this trial?

I have not been given any drugs. My tinnitus and hearing loss is getting progressively worse.
PatientReceived 1 prior treatment
I have not been able to find a cure and I have terrible tinnitus. I have very bothersome tinnitus. Lord, that is an understatement.
PatientReceived 1 prior treatment
Have tried bimodal Lenire and other methods without success/effect.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many visits are there? What is the process? Are there actual injections into the ear or skull? How many do I need? Does this trial have any compensation?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of Minnesota: < 48 hours
Average response time
  • < 2 Days
~14 spots leftby Jun 2025