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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC003209 | U.S. NIH Grant/Contract | View source |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids | Drug | |||
| Methotrexate | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Jeffrey Harris | Study Chair | |
| Dr. Patrick Brookhouser | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Ear Institute | Los Angeles | California | 90057 | United States | ||
| UCSD Medical Center |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D001327 | Autoimmune Diseases |
| D007759 | Labyrinth Diseases |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000630 | Aminopterin |
| D011622 | Pterins |
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| San Diego |
| California |
| 92103-8895 |
| United States |
| Univ of Iowa Hosp and Clinic | Iowa City | Iowa | 52242-1078 | United States |
| Johns Hopkins Univ | Baltimore | Maryland | 21287-0008 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| Univ of Michigan | Ann Arbor | Michigan | 48109-0005 | United States |
| New York University | New York | New York | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195-5245 | United States |
| University of Texas, Southwestern Medical Center at Dallas | Dallas | Texas | United States |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |