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 ]

The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 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