Autoimmunity in Inner Ear Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00000361 |
|
Recruitment Status :
Terminated
First Posted : November 3, 1999
Last Update Posted : April 24, 2006
|
Sponsor:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hearing Loss, Sensorineural | Drug: Corticosteroids Drug: Methotrexate | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Study Start Date : | March 1998 |
| Study Completion Date : | November 2002 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Nonsyndromic hearing loss
Drug Information available for:
Methotrexate
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
| Study Chair: | Dr. Jeffrey Harris | ||
| Principal Investigator: | Dr. Patrick Brookhouser |
| ClinicalTrials.gov Identifier: | NCT00000361 History of Changes |
| Other Study ID Numbers: |
NIDCD-1158 U01DC003209 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 3, 1999 Key Record Dates |
| Last Update Posted: | April 24, 2006 |
| Last Verified: | April 2006 |
Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
|
Autoimmune Diseases Cyclophosphamide Hearing |
Labyrinth Diseases Methotrexate Prednisone |
Additional relevant MeSH terms:
|
Hearing Loss Hearing Loss, Sensorineural Hearing Disorders Ear Diseases 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 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 |