Clinical Trial of Etanercept (TNF-α Blocker) for Treatment of Blast-Induced Tinnitus

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this multi-site research study is to determine if Etanercept, compared to a placebo, significantly reduces the severity of tinnitus (ringing in the ears) associated with history of blast and/or noise exposure or associated with Traumatic Brain Injury (TBI) and/or concussion. Individuals who qualify will be randomized into one of two groups: The group receiving the medication Etanercept or the group receiving a saline solution placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Tinnitus of at least a moderate severity as defined by a score of ≥ 25 points or higher on the Tinnitus Functional Index (TFI) questionnaire associated with one or more of the following:

‣ Blast- or noise exposure

⁃ Traumatic brain injury (TBI) and/or concussion diagnosed by a health care provider.

• Able to provide written informed consent.

• Age: Minimum 18 years of age at the time of enrollment.

• Other concurrent treatments for tinnitus: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.

• a) Hearing aids are permitted if the participant has been wearing them for at least 4 weeks.

• Hearing function: All degrees of hearing function can be included, recognizing that individuals with profound, bilateral hearing loss will not be able to perform tinnitus evaluations and hearing tests but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important sub-population because of the challenges in treating them with acoustic therapy and the need for a medical intervention.

• Additional tinnitus characteristics:

• a) Tinnitus history: Onset associated with blast and/or noise exposure or associated with diagnosed TBI and/or concussion. Subjects will have blast exposure, noise exposure, traumatic brain injury (TBI), and/or concussion impact, defined as exposure/impact less than or longer than six months at time of enrollment.

• i. Participants enrolled with tinnitus associated with TBI and/or concussion must have received a diagnosis of TBI and/or concussion by a health care provider.

• b) Stability: Constant (not pulsatile or intermittent). c) Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.

Locations
United States
Florida
Advent Health
RECRUITING
Celebration
University of Miami
RECRUITING
Coral Gables
Michigan
Wayne State University
RECRUITING
Detroit
Michigan Ear Institute
RECRUITING
Farmington Hills
Contact Information
Primary
Jamal Chehab
tinnitustrial@wayne.edu
313-577-5495
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-09
Participants
Target number of participants: 88
Treatments
Experimental: Etanercept Injection Group
Subjects will receive 2 X 25mg/ 1ml etanercept injection (experimental) weekly for 12 weeks.
Placebo_comparator: Placebo Injection Group
Subjects will receive 2 X 1ml saline injection (placebo) weekly for 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: University of Miami, Michigan Ear Institute
Leads: Wayne State University

This content was sourced from clinicaltrials.gov