Phase 2
N=12
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
Sensorineural Hearing Loss · Autoimmune Inner Ear Disease
Bottom Line
View on ClinicalTrials.gov: NCT01267994 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease — 7 responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Andrea Vambutas
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease |
7 | — |
| SECONDARY Number of Serious Adverse Events Reported |
— | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01267994). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.