Cytokine Inhibitor

Etanercept for Tinnitus

Wayne State University, Detroit, MI
Etanercept +1 morePhase 2RecruitingLed by Jinsheng Zhang, Ph. D.Research Sponsored by Wayne State University

Study Summary

This trial will test whether 2 injections of the drug Etanercept can help treat tinnitus caused by exposure to loud noises.

Eligible Conditions
  • Noise-Induced Tinnitus

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have ringing in your ears caused by loud noise exposure, and it's moderate or severe based on a questionnaire or self-rating test.
You have experienced ringing in your ears after being exposed to loud noises, such as a blast or noise, either recently or in the past six months.
Your tinnitus can be in one or both ears, or in your head.
People with all levels of hearing ability can participate, but those with severe hearing loss may not be able to complete certain hearing tests. This group is particularly important because they have difficulty responding to acoustic therapy and may require medical intervention.
Your tinnitus (ringing in the ears) is consistent and not constantly changing or fluctuating in loudness or location. This is important for accurate testing.
People with different levels of hearing function can join the study. Even if you have severe hearing loss and cannot complete certain tests, you can still participate by giving your opinion on how loud and bothersome your tinnitus is and how it affects your life. This is important because it helps us understand how to treat people with hearing difficulties.
You have experienced ringing in your ears (tinnitus) that started after being exposed to loud noises or explosions. The exposure can be either recent (less than 6 months ago) or historical (6 months or longer ago) at the time of joining the study.
Your tinnitus is constant and doesn't change in loudness or location. Tinnitus that comes and goes makes it difficult to measure accurately.
The location where you hear the ringing sound in your ears doesn't matter. It can be in one ear, both ears, or even inside your head.
You have loud ringing in your ears that was caused by a loud noise or explosion, and it's bothering you a lot.
Sorry, but I can't provide the information you're looking for.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The for hearing sensitivity is the change in pure-tone audiometric threshold
The for tinnitus severity is the Tinnitus Functional Index (TFI).
The for tinnitus severity is the Tinnitus Primary Function (TPF).
Secondary outcome measures
The for hearing sensitivity is the change in word recognition score.
The for hospital anxiety and depression scale (HADS).
for tinnitus loudness is Minimum masking level (MML)
+2 more
Other outcome measures
Exploratory Aim Identify contributing factors that influence the therapeutic effects of Etanercept on blast-induced tinnitus - Age
Exploratory Aim Identify contributing factors that influence the therapeutic effects of Etanercept on blast-induced tinnitus - Hearing sensitivity
Exploratory Aim Identify contributing factors that influence the therapeutic effects of Etanercept on blast-induced tinnitus - History of noise exposure, which can be captured with questionnaires
+3 more

Side effects data

From 2015 Phase 4 trial • 491 Patients • NCT01578850
Upper respiratory tract infection
Study treatment Arm
Open-Label Treatment

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Etanercept Injection GroupExperimental Treatment1 Intervention
Subjects will receive 2 X 25mg/ 1ml etanercept injection (experimental) weekly for 12 weeks.
Group II: Placebo Injection GroupPlacebo Group1 Intervention
Subjects will receive 2 X 1ml saline injection (placebo) weekly for 12 weeks.
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Find a site

Who is running the clinical trial?

University of MiamiOTHER
849 Previous Clinical Trials
381,557 Total Patients Enrolled
United States Naval Medical Center, San DiegoFED
101 Previous Clinical Trials
26,687 Total Patients Enrolled
1 Trials studying Tinnitus
151 Patients Enrolled for Tinnitus
Michigan Ear InstituteUNKNOWN
University of IowaOTHER
428 Previous Clinical Trials
870,064 Total Patients Enrolled
3 Trials studying Tinnitus
296 Patients Enrolled for Tinnitus
Madigan Army Medical CenterFED
48 Previous Clinical Trials
17,898 Total Patients Enrolled
Wayne State UniversityLead Sponsor
295 Previous Clinical Trials
105,085 Total Patients Enrolled
Portland VA Medical CenterFED
39 Previous Clinical Trials
7,309 Total Patients Enrolled
Jinsheng Zhang, Ph. D.Principal Investigator
Wayne State University

Media Library

Etanercept (Cytokine Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04066348 — Phase 2
Tinnitus Research Study Groups: Placebo Injection Group, Etanercept Injection Group
Tinnitus Clinical Trial 2023: Etanercept Highlights & Side Effects. Trial Name: NCT04066348 — Phase 2
Etanercept (Cytokine Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04066348 — Phase 2
Tinnitus Patient Testimony for trial: Trial Name: NCT04066348 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Etanercept typically employed for medical purposes?

"Etanercept is normally prescribed to alleviate moderate-to-severe symptoms and has been proven useful in treating diseases such as rheumatoid arthritis, ankylosing spondylitis, and others."

Answered by AI

Has Etanercept been sanctioned by the United States Food and Drug Administration?

"After assessing the data, our team at Power assigned Etanercept a safety score of 2 due to Phase 2 trial results which confirm its relative security but lack evidence for efficacy."

Answered by AI

Could you delineate the myriad of studies conducted utilizing Etanercept?

"Etanercept has been subject to 650 completed studies since its first research at University of Nebraska Medical Center in 2007. Currently, 34 active investigations are being conducted, with multiple sites located in Farmington Hills, Michigan."

Answered by AI

Is enrollment for this experiment still available?

"According to the information on, this medical trial is currently recruiting individuals for participation. The initial posting was made in July 1st 2022 and an edit occurred a few weeks later on July 12th 2022."

Answered by AI

What can we anticipate as the outcome from this experiment?

"The purpose of this 36-week trial is to measure the efficacy and safety of Etanercept in reducing tinnitus severity, loudness, and associated anxiety and depression. The primary outcome for tinnitus severity will be assessed using the Tinnitus Functional Index (TFI). As a secondary outcome, subjects must complete a Tinnitus Loudness Matching test while wearing foam earphones in an acoustically treated sound booth. Additionally, patients' self-reported data on their levels of anxiety and depression with Hospital Anxiety & Depression scale (HADS), as well as Visual Numerical Scale (VNS) for self"

Answered by AI

How many places are conducting this experiment?

"This research effort is seeking participants from Michigan Ear Institute in Farmington Hills, University of Arizona-AHSC Bldg in Tucson and Wayne State University in Detroit alongside 9 other medical centres."

Answered by AI

How many participants are contributing to this research endeavor?

"This trial requires 310 eligible patients to complete it, and they can do this by visiting either Michigan Ear Institute in Farmington Hills or University of Arizona-AHSC Bldg in Tucson."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
University of Arizona-AHSC Bldg
University of Miami
Naval Medical Center San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

The ringing in the ears. Would love to help find a cure. Audiologist told me nothing can be done.
The ringing in my ears is hard to ignore at times. Hoping this trial will help address this condition.

What questions have other patients asked about this trial?

What are the risks? How long and how often are screening sessions?

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Naval Medical Center San Diego: < 24 hours
  2. University of Arizona-AHSC Bldg: < 24 hours
  3. VA Portland Health Care System: < 24 hours
Average response time
  • < 2 Days
~131 spots leftby Sep 2024