What is the mechanism of action of this treatment?

Xeomin (incobotulinumtoxinA) injections treat tinnitus by blocking the release of acetylcholine at the neuromuscular junction, leading to muscle relaxation. This is significant for tinnitus patients as it may help alleviate the involuntary muscle contractions that contribute to the ringing sensation. Other treatments, such as neuromodulation, work by altering nerve activity to reduce the perception of tinnitus. Understanding these mechanisms is crucial for patients as it helps them and their doctors choose the most appropriate treatment based on the underlying causes of their tinnitus.

What side effects are associated with this type of intervention?

Botulinum toxin injections, such as Xeomin (incobotulinumtoxinA), used for treating tinnitus, commonly cause localized pain at the injection site, transient muscle weakness, and flu-like symptoms. Less frequent side effects include dry mouth, difficulty swallowing, and unintended muscle paralysis in adjacent areas. These side effects are typically mild and temporary.

What prior FDA approvals exist?

There is no specific mention in the provided context of prior FDA approvals for the treatment of tinnitus using drugs similar to Xeomin (incobotulinumtoxinA) injections, which block acetylcholine release at the neuromuscular junction. The context does mention a study assessing the effectiveness of Xeomin injections for tinnitus relief, but it does not provide information on FDA-approved treatments for tinnitus using this or similar mechanisms.

What other types of research exist?

Promising novel alternatives to Xeomin injections for tinnitus treatment include neuromodulation techniques such as transcranial magnetic stimulation (TMS) and transcutaneous electrical nerve stimulation (TENS). These methods have shown potential in clinical trials for reducing tinnitus symptoms by modulating neural activity. Additionally, cognitive behavioral therapy (CBT) and sound therapy are non-invasive options that have demonstrated efficacy in managing tinnitus.

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Neurotoxin

Xeomin Injections for Tinnitus

Phase 2

Waitlist Available

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-injection baseline to 4-6 weeks post injection

Summary

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.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection where I might get injections.

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

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-injection baseline to 4-6 weeks post injection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Xeomin (incobotulinumtoxinA) injections treat tinnitus by blocking the release of acetylcholine at the neuromuscular junction, leading to muscle relaxation. This is significant for tinnitus patients as it may help alleviate the involuntary muscle contractions that contribute to the ringing sensation. Other treatments, such as neuromodulation, work by altering nerve activity to reduce the perception of tinnitus. Understanding these mechanisms is crucial for patients as it helps them and their doctors choose the most appropriate treatment based on the underlying causes of their tinnitus.