NCT04066348

TNF-α Treatment of Blast-Induced Tinnitus

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives are to test if: 1) Etanercept significantly reduces tinnitus distress as measured by Tinnitus Functional Index (TFI); and 2) Etanercept improves hearing. In addition, the investigators will explore whether Etanercept treatment leads to sustained therapeutic effects over time; The secondary objective is to test if: 1) Etanercept reduces tinnitus loudness measured by visual numeric scale (VNS) rating.

Conditions

• Tinnitus, Noise Induced

Interventions

Type	Name	Description
BIOLOGICAL	Etanercept	To treat blast or noise induced tinnitus
OTHER	Saline	Placebo

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2019-08-26
• Last updated: 2026-02-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study