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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00000361 |
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.
Condition | Intervention | Phase |
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Hearing Loss, Sensorineural |
Drug: Corticosteroids Drug: Methotrexate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
House Ear Institute | |
Los Angeles, California, United States, 90057 | |
UCSD Medical Center | |
San Diego, California, United States, 92103-8895 | |
United States, Iowa | |
Univ of Iowa Hosp and Clinic | |
Iowa City, Iowa, United States, 52242-1078 | |
United States, Maryland | |
Johns Hopkins Univ | |
Baltimore, Maryland, United States, 21287-0008 | |
United States, Massachusetts | |
Massachusetts Eye and Ear Infirmary | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Univ of Michigan | |
Ann Arbor, Michigan, United States, 48109-0005 | |
United States, New York | |
New York University | |
New York, New York, United States | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195-5245 | |
United States, Texas | |
University of Texas, Southwestern Medical Center at Dallas | |
Dallas, Texas, United States |
Study Chair: | Dr. Jeffrey Harris | |
Principal Investigator: | Dr. Patrick Brookhouser |
Study ID Numbers: | NIDCD-1158, UO1 DC 03209 |
Study First Received: | November 2, 1999 |
Last Updated: | April 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00000361 |
Health Authority: | United States: Federal Government |
Autoimmune Diseases Cyclophosphamide Hearing |
Labyrinth Diseases Methotrexate Prednisone |
Prednisone Sensation Disorders Autoimmune Diseases Otorhinolaryngologic Diseases Sensorineural hearing loss Hearing Loss, Sensorineural Cyclophosphamide Ear Diseases |
Folic Acid Signs and Symptoms Deafness Hearing Disorders Neurologic Manifestations Methotrexate Hearing Loss |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |