CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Anakinradrug
Likely dose
Anakinra 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01267994
NCT01267994Phase 2Completed
CompareCT.gov

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

Andrea Vambutas·interventional·Posted Dec 29, 2010·Updated Jan 10, 2018

In Brief

A Phase 2 clinical trial evaluating Anakinra for Sensorineural Hearing Loss and Autoimmune Inner Ear Disease. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSensorineural Hearing Loss, Autoimmune Inner Ear Disease
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2010
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.5 years ago

Interventions

Anakinradrug

100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.