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Etanercept for Tinnitus
Study Summary
This trial will test whether 2 injections of the drug Etanercept can help treat tinnitus caused by exposure to loud noises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 491 Patients • NCT01578850Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Placebo Injection Group
- Group 2: Etanercept Injection Group
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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"
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
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
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