Autoimmunity in Inner Ear Disease
2 other identifiers
interventional
N/A
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 1998
Longer than P75 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedApril 24, 2006
April 1, 2006
November 2, 1999
April 21, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
House Ear Institute
Los Angeles, California, 90057, United States
UCSD Medical Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dr. Jeffrey Harris
- PRINCIPAL INVESTIGATOR
Dr. Patrick Brookhouser
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
November 3, 1999
Study Start
March 1, 1998
Study Completion
November 1, 2002
Last Updated
April 24, 2006
Record last verified: 2006-04