A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
Completed · Phase 1/Phase 2
Conditions studied: Sensorineural Hearing Loss, Autoimmune Inner Ear Disease
In brief
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.
Key facts
- Study ID
- NCT01267994
- Run by
- Andrea Vambutas
- People needed
- 13
- Starts
- 2011-06-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2018-01-10
Who can join
Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- North Shore-LIJ Hearing and Speech Center — New Hyde Park, New York, United States
Full record on ClinicalTrials.gov
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