Conditions: Sensorineural Hearing Loss Autoimmune Inner Ear Disease
Keywords: Steroid Steroid-Resistant Autoimmune Inner Ear Disease Immune Mediated Hearing Loss Sudden Sensorineural Hearing Loss Meniere's Disease Autoimmune Hearing
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief 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.

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.

Arms:
arm 1: Single Arm-Open Label use of Anakinra

Interventions: intervention 1: Anakinra
Intervention descriptions: intervention 1: 100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Protocol document: