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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Xeomin injections (incobotulinum toxin A) can reduce the ringing in the ears caused by tinnitus, a condition affecting many people. Researchers aim to assess the effectiveness of these injections using the Tinnitus Handicap Inventory survey. The study includes two groups: one receiving the actual injections and another receiving a placebo (a harmless solution with no active treatment). The trial seeks participants who have experienced tinnitus in one or both ears for more than two months and find it significantly impacts their daily life. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that incobotulinum toxin A, also known as Xeomin, is generally safe for people. The FDA has approved it for conditions like cervical dystonia (a neck muscle disorder) and blepharospasm (uncontrollable blinking). Studies have found that most people using Xeomin for these conditions experience only mild side effects, such as soreness at the injection site or temporary muscle weakness. No strong evidence links the treatment to serious side effects, suggesting it is well-tolerated. However, individual experiences with any medical treatment can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tinnitus?

Most treatments for tinnitus focus on masking the noise or using hearing aids and sound therapies to manage symptoms. However, incobotulinum toxin A, used in the Xeomin injections, works differently by targeting the auricular muscles directly. This approach is unique because it uses a neurotoxin to potentially reduce the perception of tinnitus through muscle relaxation. Researchers are excited about this treatment because it offers a new mechanism of action that could provide relief for patients who haven't found success with traditional therapies.

What evidence suggests that Xeomin injections might be an effective treatment for tinnitus?

Research has shown that Xeomin, a form of botulinum toxin A, might help reduce tinnitus symptoms by affecting the muscles around the ear. In this trial, participants in the Incobotulinum toxin A group will receive three serial injections of incobotulinum toxin A into the auricular muscles. One study found that 7 patients experienced improvements in their tinnitus symptoms after receiving botulinum toxin A, while only 2 patients improved with a placebo. This suggests that Xeomin might help lessen the constant ringing sound some people hear. Additionally, scores from the Tinnitus Handicap Inventory, which measures how tinnitus affects daily life, improved after using botulinum toxin A. These findings suggest that Xeomin could be a promising option for tinnitus relief. ^{1 4 6 7 8}

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05650645

The Efficacy of Incobotulinum Toxin A Injections for ...

The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15944559/

Evaluation of botulinum toxin A in treatment of tinnitus

After botulinum toxin A, subjective tinnitus changes included 7 patients improved, 3 worsened, and 16 unchanged. Following placebo, 2 patients were improved, 7 ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S019459980500255X

Evaluation of botulinum toxin A in treatment of tinnitus

Conclusions. This small study found improvement in THI scores and patient subjective results after botulinum toxin A injection compared with placebo, ...

4.

withpower.com

withpower.com/trial/phase-2-tetanus-2023-e324e

Xeomin Injections for Tinnitus · Info for Participants

Research suggests that botulinum toxin A, similar to Xeomin, may help improve tinnitus by affecting the interaction between the auditory and somatosensory ...

5.

app.trialscreen.org

app.trialscreen.org/trials/phase-2-tetanus-efficacy-incobotulinum-toxin-injections-treatment-tinnitus-trial-nct05650645

The Efficacy of Incobotulinum Toxin A Injections for ...

Xeomin (incobotulinumtoxinA) injections into the auricular muscles has been studied to assess its effectiveness in relieving tinnitus. The study ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf

Xeomin - accessdata.fda.gov

Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases,b e observed beyond the site ...

7.

aetna.com

aetna.com/cpb/medical/data/100_199/0113.html

Botulinum Toxin - Medical Clinical Policy Bulletins

Aetna considers Dysport and Myobloc to be medically necessary only for members who have a contraindication, intolerance or ineffective response.

8.

pdf.hres.ca

pdf.hres.ca/dpd_pm/00045539.PDF

incobotulinumtoxinA

The safe and effective use of XEOMIN® depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration ...