Hearing Loss, Sudden Clinical Trial
Official title:
A Phase I & II Open-label Study of the Effects of Anakinra (Kineret) in Corticosteroid-resistant Subjects With Sudden Sensorineural Heaing Loss (SSNHL)
The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist)
can improve hearing thresholds in patients with sudden sensorineural hearing loss that did
not respond to oral steroid therapy. 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.
The investigators will be measuring hearing thresholds (Pure tone average and word
recognition scores) before and after anakinra and correlating these findings with
circulating IL-1 levels in the patient's blood.
For patients that experience an acute, sensorineural decline in hearing, timely corticosteroid administration may result in preservation of some or all of the hearing. For patients with sudden sensorineural hearing loss who have failed to respond to corticosteroid therapy, this study will be offered to determine if anakinra is a safe and effective alternative therapy for clinical hearing restoration. The investigators have previously demonstrated that IL-1beta inhibition (with anakinra) in a small cohort of patients with steroid resistant autoimmune inner ear disease was effective in demonstrating audiological improvements. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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