What is the mechanism of action of this treatment?

TNF inhibitors like Etanercept work by blocking tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation, which is believed to contribute to tinnitus, especially in cases related to noise or blast injuries. By reducing inflammation, these inhibitors may help alleviate tinnitus symptoms. Other common treatments include cognitive behavioral therapy (CBT), which addresses the psychological impact, and sound therapy, which aims to mask the tinnitus noise. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the underlying cause of tinnitus.

What side effects are associated with this type of intervention?

TNF inhibitors, such as Etanercept, are being studied for the treatment of tinnitus. Common side effects of TNF inhibitors include injection site reactions, infections, headache, and gastrointestinal symptoms. Serious but less common side effects can include increased risk of infections, reactivation of latent tuberculosis, and potential for autoimmune conditions. It is important for patients to discuss these potential risks with their healthcare provider.

What prior FDA approvals exist?

There are no specific mentions of FDA-approved treatments for tinnitus similar to Etanercept (a TNF inhibitor) in the provided context. Generally, tinnitus treatments include sound therapy, cognitive behavioral therapy, and medications such as antidepressants and anticonvulsants, though these are not specifically FDA-approved for tinnitus. Research is ongoing to find more effective treatments.

What other types of research exist?

Promising novel alternatives to Etanercept for tinnitus patients include monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) such as Erenumab and Fremanezumab. These have shown efficacy and safety in migraine prevention, which may translate to potential benefits in tinnitus treatment. Further research and clinical trials are needed to confirm their effectiveness specifically for tinnitus.

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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.

Must not have

History or evidence of significant brain malformation, cerebral vascular events (such as strokes), neurodegenerative disorders affecting the brain (such as Parkinson's disease, ALS, Huntington's disease or Multiple sclerosis), or prior brain surgery

History of Guillain-Barré syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Summary

This trial tests if Etanercept injections can help adults with noise-induced tinnitus by reducing inflammation. The study aims to see if it can lower tinnitus distress and loudness, and improve hearing.

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.

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.

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 below

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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 my TFI score or how loud I rate it.

Select...

I am at least 18 years old.

Select...

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.

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I have moderate to severe tinnitus from a brain injury, confirmed by a TFI score of 25 or more.

Select...

I have moderate to severe tinnitus from noise exposure or head injury.

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I am at least 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of major brain issues or surgeries.

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I have had Guillain-Barré syndrome in the past.

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I have an active cancer, like lymphoma or a solid tumor.

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I have been diagnosed with congestive heart failure.

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I have a history of seizures or epilepsy.

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I do not have an active infection like TB, HIV, hepatitis B, or chicken pox.

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I have a condition like diabetes, an autoimmune disease, or a weak immune system.

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I am not currently taking abatacept, cyclophosphamide, sulfasalazine, or similar medications.

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I am a woman of child-bearing age not using contraception or I am breastfeeding.

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My memory and thinking skills test score is below 24.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tinnitus Functional Index (TFI)

Secondary study objectives

Audiometric testing

Tinnitus Primary Function Questionnaire

Tinnitus Testing

+1 more

Other study objectives

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

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

~4720

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

TNF inhibitors like Etanercept work by blocking tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation, which is believed to contribute to tinnitus, especially in cases related to noise or blast injuries. By reducing inflammation, these inhibitors may help alleviate tinnitus symptoms. Other common treatments include cognitive behavioral therapy (CBT), which addresses the psychological impact, and sound therapy, which aims to mask the tinnitus noise. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the underlying cause of tinnitus.