Clinical Trial: Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I & II Open-label Study of the Effects of Anakinra (Kineret) in Corticosteroid-resistant Subjects With Sudden Sensorineural Heaing Loss (SSNHL)

Brief Summary:

The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in patients with sudden sensorineural hearing loss that did not respond to oral steroid therapy. 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.

The investigators will be measuring hearing thresholds (Pure tone average and word recognition scores) before and after anakinra and correlating these findings with circulating IL-1 levels in the patient's blood.


Detailed Summary: For patients that experience an acute, sensorineural decline in hearing, timely corticosteroid administration may result in preservation of some or all of the hearing. For patients with sudden sensorineural hearing loss who have failed to respond to corticosteroid therapy, this study will be offered to determine if anakinra is a safe and effective alternative therapy for clinical hearing restoration. The investigators have previously demonstrated that IL-1beta inhibition (with anakinra) in a small cohort of patients with steroid resistant autoimmune inner ear disease was effective in demonstrating audiological improvements.
Sponsor: Andrea Vambutas

Current Primary Outcome: Response to Anakinra in Corticosteroid Resistant Patients With SSNHL [ Time Frame: 120 days ]

Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.


Original Primary Outcome: Primary measure will be the "response" at Day 28, 56 and 84 which will be defined as an improvement in PTA (>5db at the average of 250,500,1000,2000 and 4000Hz) or WRS (greater or equal to 12%) [ Time Frame: 120 days ]

Patients will be treated with 28 consecutive injections of anakinra, a hearing reassessment at days 28, 56 and 84. If a positive complete response, as measured by the protocol, is seen at day 28, no further therapy will be instituted and the patient will be reassessed at day 56. If an incomplete or no response is seen at day 28, an additional 28 day cycle of anakinra will be administered.


Current Secondary Outcome:

Original Secondary Outcome: Retreatment of relapsed subjects who had previously were determined to be complete responders [ Time Frame: 120 days ]

Patients who had a complete positive response at day 28, maintained at day 56, but lost by day 84 will be retreated with an additional 28 day course of anakinra


Information By: Northwell Health

Dates:
Date Received: February 23, 2015
Date Started: October 2013
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017