Autoimmunity in Inner Ear Disease
This study has been terminated.
Sponsor:
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:
NCT00000361
First received: November 2, 1999
Last updated: April 21, 2006
Last verified: April 2006
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hearing Loss, Sensorineural |
Drug: Corticosteroids Drug: Methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.
- Are in good general health.
- Are sterile or use contraception (if a woman of child-bearing age).
- Are able to speak and understand English or Spanish.
Exclusion Criteria:
- Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.
- Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.
- Have any significant heart, lung, digestive, blood, or neurologic disorders.
- Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.
- Have had a positive test for HIV, hepatitis C or B.
- Have any type of middle ear disorder.
- Are breast-feeding or pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000361
Locations
| 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 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Dr. Jeffrey Harris | |
| Principal Investigator: | Dr. Patrick Brookhouser |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00000361 History of Changes |
| Other Study ID Numbers: | NIDCD-1158, UO1 DC 03209 |
| Study First Received: | November 2, 1999 |
| Last Updated: | April 21, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
|
Autoimmune Diseases Cyclophosphamide Hearing |
Labyrinth Diseases Methotrexate Prednisone |
Additional relevant MeSH terms:
|
Ear Diseases Hearing Loss Deafness Hearing Loss, Sensorineural Labyrinth Diseases Hearing Disorders Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013