View Clinical Trial (Medical Research Study)
A Phase I Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
| City: |
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New Hyde Park |
| State: |
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New York |
| Zip Code: |
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11040 |
| Conditions: |
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Sensorineural Hearing Loss - Autoimmune Inner Ear Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01267994 |
| Primary Contact: |
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Principal Investigator
Andrea Vambutas, MD
North Shore-LIJ Health System
Andrea Vambutas, MD
Phone: 718-470-7550
Email: vambutas@nshs.edu
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| Backup Contact: |
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Email: GMullool@nshs.edu
Virginia Mullooly, RN
Phone: 718-470-7550
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| Location Contact: |
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New Hyde Park, New York 11040
United States
Andrea Vambutas, MD
Phone: 718-470-7748
Email: vambutas@nshs.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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