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A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
This study has been completed.
Sponsor:
Andrea Vambutas
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
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: March 23, 2015
Last verified: March 2015
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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: | 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:
Genetics Home Reference related topics:
nonsyndromic hearing loss
Drug Information available for:
Anakinra
Genetic and Rare Diseases Information Center resources:
Sudden Sensorineural Hearing Loss
Autoimmune Inner Ear Disease
U.S. FDA Resources
Further study details as provided by Andrea Vambutas, 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 ]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 ]
| Enrollment: | 13 |
| Study Start Date: | June 2011 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm-Open Label
Single Arm-Open Label use of Anakinra
|
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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01267994
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
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
| Principal Investigator: | Andrea Vambutas, MD | Northwell Health |
More Information
Additional Information:
Publications:
| 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 ( U.S. NIH Grant/Contract ) R33DC011827 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 28, 2010 |
| Results First Received: | September 16, 2014 |
| Last Updated: | March 23, 2015 |
Keywords provided by Andrea Vambutas, 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 Hearing Loss, Sensorineural Ear Diseases 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 |
ClinicalTrials.gov processed this record on July 21, 2017