Skip to main content
OpenTrials
Completed

NCT Number: NCT01267994

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sensorineural Hearing Loss Autoimmune Inner Ear Disease Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Hearing Loss, Sudden Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

13 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

North Shore-LIJ Hearing and Speech Center

New Hyde Park, New York, 11040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anakinra

Drug

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

Other names: Kineret

Primary outcomes

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

    Time frame: 180 days

    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 outcomes

  1. Number of Serious Adverse Events Reported

    Time frame: 84 days

    To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

Sponsors and collaborators

Lead sponsor

Andrea Vambutas

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 29, 2010
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.