TNF-α Treatment of Blast-Induced Tinnitus

Part of paid clinical trials in Celebration, Florida.

Sponsor
Wayne State University
Study ID
NCT04066348
Phase
PHASE2
Status
Recruiting
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Conditions

  • Tinnitus, Noise Induced

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etanercept — BIOLOGICAL
    To treat blast or noise induced tinnitus
  • Saline — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Tinnitus Functional Index (TFI) [ Time Frame: 12 Weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Advent HealthCelebrationFlorida34747
Jamal Chehab, RN
[email protected]
University of MiamiCoral GablesFlorida33124
Michael Hoffer, MD (PRINCIPAL_INVESTIGATOR)
Wayne State UniversityDetroitMichigan48201
Jinsheng Zhang, Ph.D. (PRINCIPAL_INVESTIGATOR)
Michigan Ear InstituteFarmington HillsMichigan48334
Robert Hong, MD/Ph.D. (PRINCIPAL_INVESTIGATOR)
Dennis Bojrab (SUB_INVESTIGATOR)

Find similar trials in Celebration, FL

By research site
Advent Health· Celebration, FLUniversity of Miami· Coral Gables, FLWayne State University· Detroit, MIMichigan Ear Institute· Farmington Hills, MI

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