Back to resultsAutoimmunity in Inner Ear Disease
Primary Purpose
Hearing Loss, Sensorineural
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Corticosteroids
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Autoimmune Diseases, Cyclophosphamide, Hearing, Labyrinth Diseases, Methotrexate, Prednisone
Eligibility 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.
Sites / Locations
- House Ear Institute
- UCSD Medical Center
- Univ of Iowa Hosp and Clinic
- Johns Hopkins Univ
- Massachusetts Eye and Ear Infirmary
- Univ of Michigan
- New York University
- Cleveland Clinic Foundation
- University of Texas, Southwestern Medical Center at Dallas
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000361
First Posted
November 2, 1999
Last Updated
April 21, 2006
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00000361
Brief Title
Autoimmunity in Inner Ear Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Terminated
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
Autoimmune Diseases, Cyclophosphamide, Hearing, Labyrinth Diseases, Methotrexate, Prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Intervention Type
Drug
Intervention Name(s)
Methotrexate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jeffrey Harris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Patrick Brookhouser
Official's Role
Principal Investigator
Facility Information:
Facility Name
House Ear Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8895
Country
United States
Facility Name
Univ of Iowa Hosp and Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1078
Country
United States
Facility Name
Johns Hopkins Univ
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0008
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Univ of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0005
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5245
Country
United States
Facility Name
University of Texas, Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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Autoimmunity in Inner Ear Disease
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