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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea Vambutas, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01267994
First received: December 28, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Sensorineural Hearing Loss
Autoimmune Inner Ear Disease
Drug: Anakinra
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • To assess the potential efficacy of anakinra in improving hearing thresholds in corticosteroid-resistant patients with Autoimmune Inner Ear Disease [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.


Secondary Outcome Measures:
  • To assess the safety and tolerability of a three month (84 day) course of anakinra in corticosteroid resistant patients with Autoimmune Inner Ear Disease. [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anakinra
    100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
    Other Name: Kineret
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.

  Eligibility

Ages Eligible for Study:   13 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267994

Locations
United States, New York
North Shore-LIJ Hearing and Speech Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Andrea Vambutas
Investigators
Principal Investigator: Andrea Vambutas, MD North Shore-LIJ Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Andrea Vambutas, Professor of Otolaryngology & Molecular Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01267994     History of Changes
Other Study ID Numbers: 1R21DC011827-01, R33DC011827
Study First Received: December 28, 2010
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Steroid
Steroid-Resistant
Autoimmune Inner Ear Disease
Immune Mediated Hearing Loss
Sudden Sensorineural Hearing Loss
Meniere's Disease
Autoimmune
Hearing

Additional relevant MeSH terms:
Hearing Loss
Deafness
Ear Diseases
Hearing Loss, Sensorineural
Labyrinth Diseases
Labyrinthitis
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Otitis
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014