A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrea Vambutas
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

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