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Cytokine Inhibitor
Etanercept for Tinnitus
Phase 2
Recruiting
Led 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.
Age/Gender: Minimum 18 years of age at the time of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
Study Summary
This trial will test whether 2 injections of the drug Etanercept can help treat tinnitus caused by exposure to loud noises.
Who is the study for?
Adults with moderate to severe tinnitus from noise or blast exposure, or associated with traumatic brain injury (TBI) or concussion. Participants must be stable enough psychologically for the study, not have used other tinnitus treatments in the last four weeks, and able to consent. All hearing levels are included but those with profound loss can't do certain tests.Check my eligibility
What is being tested?
The trial is testing Etanercept (Enbrel), a medication given through injections, against a placebo (saline solution). The goal is to see if Etanercept can reduce the severity of tinnitus caused by loud noises or blasts. Participants will be randomly assigned to receive either Etanercept or placebo.See study design
What are the potential side effects?
Etanercept may cause side effects like injection site reactions, increased risk of infections due to immune system suppression, allergic reactions, and possibly others as it affects your body's immune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tinnitus is moderate to severe, based on my TFI score or how loud I rate it.
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I am at least 18 years old.
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My tinnitus is moderate to severe, based on my TFI score or how loud I rate it.
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I am at least 18 years old.
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My tinnitus is moderate to severe, based on specific questionnaire scores.
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I have moderate to severe tinnitus from loud noise or blast exposure.
Select...
I have moderate to severe tinnitus from a brain injury, confirmed by a TFI score of 25 or more.
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I have moderate to severe tinnitus from noise exposure or head injury.
Select...
I am at least 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
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 moreOther 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 moreSide effects data
From 2015 Phase 4 trial • 491 Patients • NCT015788505%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-Label Treatment
Etanercept
Placebo
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
2005
Completed Phase 4
~4740
Find a Location
Who is running the clinical trial?
University of IowaOTHER
446 Previous Clinical Trials
879,192 Total Patients Enrolled
3 Trials studying Tinnitus
296 Patients Enrolled for Tinnitus
United States Naval Medical Center, San DiegoFED
102 Previous Clinical Trials
22,406 Total Patients Enrolled
1 Trials studying Tinnitus
151 Patients Enrolled for Tinnitus
University of MiamiOTHER
900 Previous Clinical Trials
409,622 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with any level of hearing ability can join the study. However, individuals with severe hearing loss won't be able to do certain hearing tests.I am not currently taking abatacept, cyclophosphamide, sulfasalazine, or similar medications.You currently have a problem with drugs or alcohol.I am a woman of child-bearing age not using contraception or I am breastfeeding.You have participated in more than two previous drug trials for tinnitus.Your lab test results are not within the normal range and could be a concern.I am at least 18 years old.My hearing varies, but I can still rate my tinnitus impact.My tinnitus started after a loud noise, injury, or concussion.My tinnitus has specific features.I have not received, nor am I scheduled to receive, a live vaccine around the time of this study.Your tinnitus is not constantly changing in loudness or location, as this can make it difficult to measure accurately.Your tinnitus is not constantly changing in loudness or location, because that can make it harder to measure accurately.I have an active cancer, like lymphoma or a solid tumor.I have had Guillain-Barré syndrome in the past.My hearing varies, but I can still rate my tinnitus.I have moderate to severe tinnitus from loud noise or blast exposure.I have any level of hearing ability and may have severe hearing loss.I have had cancer before, but it was not skin or cervical cancer that was successfully treated.My memory and thinking skills test score is below 24.My tinnitus is moderate to severe, based on my TFI score or how loud I rate it.I haven't received any tinnitus treatments in the last 4 weeks.I have moderate to severe tinnitus from a brain injury, confirmed by a TFI score of 25 or more.My tinnitus started after being exposed to loud noise or a blast.I am at least 18 years old.My tinnitus is moderate to severe, based on specific questionnaire scores.I am at least 18 years old.My tinnitus is steady and doesn't change in sound or location.You are stable enough to complete this study.I experience ringing in one or both ears, or in my head.My tinnitus is moderate to severe, based on my TFI score or how loud I rate it.My tinnitus started after being exposed to loud noise or a blast.My tinnitus can be in one or both ears, or in my head.My tinnitus started after a loud noise, injury, or concussion.My hearing varies, but I can still rate my tinnitus.My tinnitus started after being exposed to loud noise or a blast.I can communicate well and follow the trial's requirements.I have a history of seizures or epilepsy.I have a condition like diabetes, an autoimmune disease, or a weak immune system.You have a pacemaker, electronic implants, or metal objects inside your head or eyes.I haven't received any tinnitus treatments in the last 4 weeks.I have no history of major brain issues or surgeries.I have been diagnosed with congestive heart failure.I do not have an active infection like TB, HIV, hepatitis B, or chicken pox.I haven't received any tinnitus treatments in the last 4 weeks.I have moderate to severe tinnitus from noise exposure or head injury.I experience ringing in one or both ears, or in my head.My tinnitus can be in one or both ears, or felt in my head.Your tinnitus should be constant and not change in loudness or location. Fluctuating tinnitus can make it harder to measure accurately.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Injection Group
- Group 2: Etanercept Injection Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What state do they live in?
Florida
California
Michigan
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Arizona-AHSC Bldg
University of Miami
Naval Medical Center San Diego
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
The ringing in the ears. Would love to help find a cure. I'm tired of the constant ringing.
PatientReceived 2+ prior treatments
Audiologist told me nothing can be done. The ringing in my ears is constant and hurts.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What are the risks? Is there one in Michigan? How long and how often are screening sessions?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Naval Medical Center San Diego: < 24 hours
- University of Arizona-AHSC Bldg: < 24 hours
- VA Portland Health Care System: < 24 hours
Average response time
- < 2 Days
Recent research and studies
Otolaryngology - Head and Neck SurgeryJournal
Clinical Associations Between Tinnitus and Chronic PainOther Trials to Consider
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