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

Sensorineural Hearing Loss Clinical Trial

Official title: A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Autoimmune Inner Ear Disease
• Deafness
• Ear Diseases
• Hearing Loss
• Hearing Loss, Sensorineural
• Labyrinth Diseases
• Labyrinthitis
• Sensorineural Hearing Loss

• NCT number: NCT01267994
• Study type: Interventional
• Source: Northwell Health
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2011
• Completion date: September 2014