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

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Brief Title

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

Official Title

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

Brief 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease

Secondary Outcome

 Number of Serious Adverse Events Reported

Condition

Sensorineural Hearing Loss

Intervention

Anakinra

Study Arms / Comparison Groups

 Single Arm-Open Label
Description:  Single Arm-Open Label use of Anakinra

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

June 2011

Completion Date

September 2014

Primary Completion Date

September 2014

Eligibility Criteria

        Inclusion Criteria:

          -  Bilateral sensorineural hearing loss with an active decline in hearing in one ear

          -  No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid,
             including an initial dose of 60mg per day for 14 days

          -  Enrollment within 14 days of completion of corticosteroid therapy

          -  Age 13 years and older

          -  No evidence of neutropenia (low white blood cell count)

          -  No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)

          -  May have concurrent, systemic autoimmune disease

        Exclusion Criteria:

          -  Age over 75, or less than 13

          -  Neutropenia

          -  Renal insufficiency

          -  Pregnant females

          -  Unilateral hearing loss

          -  Patients with any immunodeficiency syndrome

          -  Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy

          -  Patients with chronic infections

          -  Patients treated for a malignancy within the past 3 years

          -  Patients with a latex allergy

          -  Patients with an inner ear anomaly

          -  Patients with retrocochlear pathology
      

Gender

All

Ages

13 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Andrea Vambutas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01267994

Organization ID

1R21DC011827-01

Secondary IDs

R33DC011827

Responsible Party

Sponsor-Investigator

Study Sponsor

Andrea Vambutas

Collaborators

 National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Sponsor

Andrea Vambutas, MD, Principal Investigator, Northwell Health


Verification Date

December 2017