Study:
n/a
Rationale:
n/a
Purpose:
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 Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Hearing Loss, Sensorineural |
Drug: Corticosteroids
Drug: Methotrexate |
Phase 3 |
Verified by
National Institute on Deafness and Other Communication Disorders (NIDCD)
April, 2006
Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov identifier: NCT00000361
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Cleveland Clinic Foundation
Cleveland, Ohio 44195-5245
United States
Dr. Jeffrey Harris., Study Chair
Dr. Patrick Brookhouser., Principal Investigator