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Autoimmunity in Inner Ear Disease

NCT ID: NCT00000361

Last Updated: 2006-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Keywords

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Autoimmune Diseases Cyclophosphamide Hearing Labyrinth Diseases Methotrexate Prednisone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Corticosteroids

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role lead

Principal Investigators

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Dr. Jeffrey Harris

Role: STUDY_CHAIR

Dr. Patrick Brookhouser

Role: PRINCIPAL_INVESTIGATOR

Locations

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House Ear Institute

Los Angeles, California, United States

Site Status

UCSD Medical Center

San Diego, California, United States

Site Status

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, United States

Site Status

Johns Hopkins Univ

Baltimore, Maryland, United States

Site Status

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Univ of Michigan

Ann Arbor, Michigan, United States

Site Status

New York University

New York, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Texas, Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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U01DC003209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDCD-1158

Identifier Type: -

Identifier Source: org_study_id