Xeomin Injections for Tinnitus

Overseen By Robert Wudlick, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Must not be taking: Botulinum toxin

Disqualifiers: Hypersensitivity, Infection, Surgery, Psychiatric, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

33 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received botulinum toxin injections in the last 4 months, you cannot participate.

Is Xeomin (incobotulinumtoxinA) safe for use in humans?

Xeomin (incobotulinumtoxinA) has been shown to be generally safe in humans for conditions like cervical dystonia and blepharospasm, with common side effects including mild issues like dysphagia (difficulty swallowing). It is a purified form of botulinum toxin type A, which reduces the risk of immune reactions compared to other formulations with accessory proteins. ^{1 2 3 4 5}

How does the drug Xeomin (incobotulinum toxin A) differ from other tinnitus treatments?

Xeomin (incobotulinum toxin A) is unique because it involves using a form of botulinum toxin, which is not a standard treatment for tinnitus. Unlike other treatments that may involve medications like dexamethasone or lidocaine, Xeomin works by temporarily paralyzing muscles, which could help if the tinnitus is related to muscle spasms, such as in cases of stapedius myoclonus. ^{1 6 7 8 9}

What data supports the effectiveness of the drug Xeomin (incobotulinum toxin A) for treating tinnitus?

Research suggests that botulinum toxin A, similar to Xeomin, may help improve tinnitus by affecting the interaction between the auditory and somatosensory systems, which is thought to be a cause of somatic tinnitus. ^{2 9 10 11 12}

Who Is on the Research Team?

Stephanie Standal, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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

You have a Tinnitus Handicap Inventory score higher than 16.

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

Participants must be willing and able to provide informed consent.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three serial injections of incobotulinum toxin A or placebo into the auricular muscles

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• incobotulinum toxin A
• Placebo-Saline

Trial Overview 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.

How Is the Trial Designed?

Group I: Incobotulinium toxin A group Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Individuals with symptoms of tetanus will receive placebo saline injections.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of botulinum toxin A in treatment of tinnitus. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Adding Lidocaine to Dexamethasone in the Intra-tympanic Injection for Management of Tinnitus: A Prospective, Randomized, Controlled Double-blinded Trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with gabapentin: a pilot study. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Botulinum toxin for the treatment of somatic tinnitus. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Intratympanic dexamethasone injections as a treatment for severe, disabling tinnitus: does it work? [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Botox transient treatment of tinnitus due to stapedius myoclonus: case report. [2018]

7. Austria pubmed.ncbi.nlm.nih.gov

A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin(®)) in cervical dystonia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Neurotoxin Impurities: A Review of Threats to Efficacy. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus by intratympanic instillation of lignocaine (lidocaine) 2 per cent through ventilation tubes. [2019]

11. China pubmed.ncbi.nlm.nih.gov

[Effect of postaurical subcutaneously injection of triamcinolone acetonide for subjective tinnitus]. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Tinnitus program at Brasília University Medical School. [2015]