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

NCT01267994 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-01-10

Study results available
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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.

Conditions

  • Sensorineural Hearing Loss
  • Autoimmune Inner Ear Disease

Interventions

DRUG

Anakinra

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

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Andrea Vambutas

    lead OTHER

Principal Investigators

  • Andrea Vambutas, MD · Northwell Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01267994 on ClinicalTrials.gov