A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease (NCT01267994) | Clinical Trial Compass
CompletedPhase 1/2
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
United States13 participantsStarted 2011-06
Plain-language summary
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.
Who can participate
Age range
13 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Bilateral sensorineural hearing loss with an active decline in hearing in one ear
* No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
* Enrollment within 14 days of completion of corticosteroid therapy
* Age 13 years and older
* No evidence of neutropenia (low white blood cell count)
* No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
* May have concurrent, systemic autoimmune disease
Exclusion Criteria:
* Age over 75, or less than 13
* Neutropenia
* Renal insufficiency
* Pregnant females
* Unilateral hearing loss
* Patients with any immunodeficiency syndrome
* Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
* Patients with chronic infections
* Patients treated for a malignancy within the past 3 years
* Patients with a latex allergy
* Patients with an inner ear anomaly
* Patients with retrocochlear pathology
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial specifically enrolled patients who were resistant to corticosteroids, can you help me understand whether my hearing loss has truly stopped responding to steroids before we discuss whether a drug like anakinra might be relevant for me?
2This was a Phase 1/2 trial for anakinra in autoimmune inner ear disease, which means it was still in early stages of testing safety and getting initial signals on effectiveness — what do we actually know so far about whether it helped patients' hearing thresholds, and how confident can we be in those results?
3Anakinra works by blocking a specific immune signal called IL-1, which is a different approach than steroids — can you explain whether my particular case of autoimmune inner ear disease is the type where this mechanism might make biological sense to try?
4Since this trial has already been completed, has the data been published, and if so, does it suggest anakinra is being studied further or is there a newer or more proven treatment path I should consider first?
5What would the practical demands look like if anakinra were ever prescribed to me based on trials like this one — for example, how is it given, how often, and are there immune-related risks I should weigh against the potential benefit to my hearing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease