Trial record 1 of 3 for:
"Autoimmune Inner Ear disease"
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: | 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:
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 Northwell Health:
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 ]
| 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) |
| 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
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 R33DC011827 |
| Study First Received: | December 28, 2010 |
| Results First Received: | September 16, 2014 |
| Last Updated: | March 23, 2015 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Northwell Health:
|
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 September 23, 2016