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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014