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NCT04066348 · ClinicalTrials.gov registry record · Phase 2
TNF-α Treatment of Blast-Induced Tinnitus
A Phase 2 study of Tinnitus, Noise Induced, sponsored by Wayne State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 4
- Study locations
NCT04066348: Recruiting Phase 2 study of Tinnitus, Noise Induced, sponsored by Wayne State University.
NCT04066348 is a Phase 2 study of Tinnitus, Noise Induced that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04066348, a Phase 2 study of Tinnitus, Noise Induced, is actively recruiting participants, sponsored by Wayne State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Self-report questionnaire used to assess the severity and negative impact of tinnitus (tinnitus distress). It uses an 11 point Likert scale with higher scores indicating more severe tinnitus (For example, "How strong or loud was your tinnitus?", 0 (Not at all strong or loud)-10 (Extremely strong or loud).
Conditions Studied
Interventions
- BIOLOGICAL Etanercept
- OTHER Saline
Study Locations (4)
Florida
- Advent Health - Celebration
- University of Miami - Coral Gables
Michigan
- Wayne State University - Detroit
- Michigan Ear Institute - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT04066348 shows while recruiting
NCT04066348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Tinnitus, Noise Induced appearing as the primary indexed condition, and to 2 interventions - of which Etanercept is the first listed.
NCT04066348 reports a single indexed study location in Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04066348 about?
NCT04066348 is a clinical study titled "TNF-α Treatment of Blast-Induced Tinnitus". 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. Individua...
What is the current status of trial NCT04066348?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2022-07-01. Estimated completion is 2026-09.
What conditions does trial NCT04066348 study?
This clinical trial studies the following conditions: Tinnitus, Noise Induced.
What interventions are being tested in trial NCT04066348?
The interventions under investigation include: Etanercept (BIOLOGICAL), Saline (OTHER).
Who is sponsoring clinical trial NCT04066348?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04066348 being conducted?
This trial has 4 study locations across Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinnitus, Noise Induced
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04066348's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,192 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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