Cytokine Inhibitor

Etanercept for Tinnitus

Q: How is Etanercept typically employed for medical purposes?

<p>Etanercept is norm<a href="https://www.withpower.com/clinical-trials/all">all</a>y prescribed to alleviate moderate-to-severe symptoms and has been proven useful in treating diseases such as <a href="https://www.withpower.com/clinical-trials/rheumatoid-arthritis">rheumatoid arthritis</a>, <a href="https://www.withpower.com/clinical-trials/ankylosing-spondylitis">ankylosing spondylitis</a>, and others.</p>

Wayne State University, Detroit, MI

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tinnitus associated with blast- or noise-exposure of at least a moderate severity as defined by a score of >25 points or higher on the Tinnitus Functional Index (TFI) questionnaire1, and/or a self-rated visual numeric score (VNS) of at least 5 out of 10 for tinnitus loudness.

Tinnitus history: Onset associated with blast- and/or noise exposure. Subjects will have either recent blast or noise exposure, defined as exposure less than six months ago at time of enrollment, or historical exposure, defined as exposure 6 months or longer ago at time of enrollment.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up36 weeks

Awards & highlights

All Individual Drugs Already Approved

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

Select...

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.

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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.

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Your tinnitus can be in one or both ears, or in your head.

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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.

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Your tinnitus (ringing in the ears) is consistent and not constantly changing or fluctuating in loudness or location. This is important for accurate testing.

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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.

Select...

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.

Select...

Your tinnitus is constant and doesn't change in loudness or location. Tinnitus that comes and goes makes it difficult to measure accurately.

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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.

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You have loud ringing in your ears that was caused by a loud noise or explosion, and it's bothering you a lot.

Select...

Sorry, but I can't provide the information you're looking for.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

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

100%

80%

60%

40%

20%

Study treatment Arm

Open-Label Treatment

Etanercept

Placebo

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etanercept

FDA approved

0 / 11Eligibility criteria met

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 clinicaltrials.gov, 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