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The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial

Primary Purpose

Tinnitus

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
incobotulinum toxin A
Placebo-Saline
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults age 18 or older Unilateral or bilateral tinnitus present for ≥ 2 months A score >16 on the Tinnitus Handicap Inventory Participants must be willing and able to provide informed consent. Exclusion Criteria: Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation. Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening. 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. Significant psychiatric history or associated diagnosis of major depression. Women who are pregnant or breastfeeding.

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Incobotulinium toxin A group

Placebo

Arm Description

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

Individuals with symptoms of tetanus will receive placebo saline injections.

Outcomes

Primary Outcome Measures

Change in the Tinnitus Handicap Inventory score
in the group assigned to placebo for the first stage

Secondary Outcome Measures

Full Information

First Posted
December 6, 2022
Last Updated
July 24, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05650645
Brief Title
The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Official Title
The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incobotulinium toxin A group
Arm Type
Experimental
Arm Description
Individuals with symptoms of tetanus will receive three serial injections of incobotulinum toxin A into the auricular muscles.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Individuals with symptoms of tetanus will receive placebo saline injections.
Intervention Type
Drug
Intervention Name(s)
incobotulinum toxin A
Intervention Description
The study intervention is a syringe of 50 units of incobotulinum toxin A total, with 25 units per side, a total of 6 injection sites incobotulinum toxin A diluted into 1 ml of normal saline, injected in equal amounts into the anterior, superior, and posterior auricular muscles using anatomical landmarks. This will be approximately 0.16 mL (8-9 units) of the combined solution per injection site.
Intervention Type
Drug
Intervention Name(s)
Placebo-Saline
Intervention Description
Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.
Primary Outcome Measure Information:
Title
Change in the Tinnitus Handicap Inventory score
Description
in the group assigned to placebo for the first stage
Time Frame
pre-injection baseline to 4-6 weeks post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age 18 or older Unilateral or bilateral tinnitus present for ≥ 2 months A score >16 on the Tinnitus Handicap Inventory Participants must be willing and able to provide informed consent. Exclusion Criteria: Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation. Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening. 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. Significant psychiatric history or associated diagnosis of major depression. Women who are pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Standal, MD
Phone
(612)625-2661
Email
stan0621@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Wudlick, MD
Email
rehablab@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Standal, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Standal, MD
Phone
612-625-2661
Email
stan0621@umn.edu

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Incobotulinum Toxin A Injections for Treatment of Tinnitus: a Randomized Controlled Trial

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