Condition: Autoimmune Inner Ear Disease · Meniere's Disease · Sponsor: Northwell Health
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.
This description comes directly from the study's public registry record.
Ginny Mullooly, RN · 718-470-7974 · gmullool@northwell.edu
Andrea Vambutas, MD · 718-470-7550 · avambuta@northwell.edu
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| Northwell Health, Hearing& Speech Center | New Hyde Park, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT03587701