Trial record 1 of 2 for:
"Autoimmune Inner Ear disease"
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
This study is currently recruiting participants.
Verified April 2013 by North Shore Long Island Jewish Health System
Sponsor:
Andrea Vambutas
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: April 23, 2013
Last verified: April 2013
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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 |
| 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 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:
Detailed Description:
-
Drug: Anakinra
100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
Other Name: Kineret
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
Contacts
| Contact: Andrea Vambutas, MD | 718-470-7550 | vambutas@nshs.edu |
| Contact: Virginia Mullooly, RN | 718-470-7550 | GMullool@nshs.edu |
Locations
| United States, New York | |
| North Shore-LIJ Hearing and Speech Center | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Andrea Vambutas, MD 718-470-7748 vambutas@nshs.edu | |
| Contact: Virginia Mullooly, RN 718-470-7550 vmullool@nshs.edu | |
| Principal Investigator: Andrea Vambutas, MD | |
| Sub-Investigator: Gerald Zahtz, MD | |
| Sub-Investigator: Elliot Goldofsky, MD | |
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: | April 23, 2013 |
| 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 May 16, 2013