Clinical Trial: A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
Brief 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.
Detailed Summary: Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.
Sponsor: Andrea Vambutas
Current Primary Outcome: To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease [ Time Frame: 180 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To Assess the Safety and Tolerability of a Three Month (84 Day) Course of Anakinra in Corticosteroid Resistant Patients With Autoimmune Inner Ear Disease. [ Time Frame: 84 days ]
Original Secondary Outcome: Same as current
Information By: Northwell Health
Dates:
Date Received: December 28, 2010
Date Started: June 2011
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015