A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sensorineural Hearing Loss Autoimmune Inner Ear Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm-Open Label

Single Arm-Open Label use of Anakinra

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Interventions

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Anakinra

100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Intervention Type DRUG

Other Intervention Names

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Kineret

Eligibility 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

Minimum Eligible Age

13 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No