The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
House Ear Institute
Los Angeles, California, United States
UCSD Medical Center
San Diego, California, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States
Johns Hopkins Univ
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Baltimore, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Univ of Michigan
Ann Arbor, Michigan, United States
New York University
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas, United States