NCT01267994

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Andrea Vambutas · Academic / Other
• Sex: All
• Age: 13 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Sensorineural Hearing Loss
• Autoimmune Inner Ear Disease

Interventions

Type	Name	Description
DRUG	Anakinra	100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2010-12-29
• Last updated: 2018-01-10
• Results posted: 2015-04-06

Locations

1 site across 1 country: United States