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TNF-α Treatment of Blast-Induced Tinnitus

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 23, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Sep 2025 to Sep 2026v13
  2. Study sites: 3 to 4v12
  3. Secondary endpoints revised (4)v11
  4. Enrollment target: 310 to 88v10 Show 6 more changesShow less
    • Primary endpoints: 3 to 1
    • Study sites: 4 to 3
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints: 5 to 4
    • Collaborators: 4 to 2
    • Study description shortened, about 1 word
  5. Primary and study completion dates: Sep 2024 to Sep 2025v9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 28 words
    • Study description shortened, about 80 words
    • Site details revised at 1 of 4 sites
    v8
  2. Study sites: 7 to 4
    • Eligibility criteria expanded, about 120 words
    • Collaborators: 6 to 4
    v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2022 to Jul 1, 2022
    • Study sites: 9 to 7
    v6
  4. Primary completion date: Sep 2023 to Sep 2024
    • Start date: Jul 2021 to Apr 1, 2022
    v5
  5. Collaborators: 8 to 6v4
  6. Primary completion date: Sep 2022 to Sep 2023v3 Show 4 more changesShow less
    • Start date: Aug 2020 to Jul 2021
    • Study completion date: Sep 2023 to Sep 2024
    • Study sites revised (9)
    • Collaborators: 6 to 8
  7. Start date: Oct 2019 to Aug 2020
    • Interventions: Etanercept (Biological) to Etanercept (Biological), Saline (Other)
    • Collaborators: 7 to 6
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04066348
Lead Sponsor Wayne State University
Collaborators: University of Miami, Michigan Ear Institute
Conditions
(from sponsor)		 Tinnitus, Noise Induced
Related terms Tinnitus
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov