Autoimmunity in Inner Ear Disease

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00000361

Collaborator

(none)

Locations

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Drug: Corticosteroids Drug: Methotrexate	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 1998

Study Completion Date :

Nov 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	House Ear Institute	Los Angeles	California	United States	90057
2	UCSD Medical Center	San Diego	California	United States	92103-8895
3	Univ of Iowa Hosp and Clinic	Iowa City	Iowa	United States	52242-1078
4	Johns Hopkins Univ	Baltimore	Maryland	United States	21287-0008
5	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114
6	Univ of Michigan	Ann Arbor	Michigan	United States	48109-0005
7	New York University	New York	New York	United States
8	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195-5245
9	University of Texas, Southwestern Medical Center at Dallas	Dallas	Texas	United States