Autoimmunity in Inner Ear Disease

Last updated: April 21, 2006
Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Overall Status: Terminated

Phase

3

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT00000361
NIDCD-1158
U01DC003209
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, whichhas 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

Exclusion Criteria:

  • Have had any previous reaction to prednisone, or history of psychiatric reaction tocorticosteroids.

  • Have used corticosteroids for more than 30 days within the past 90 days. Patients whohave 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.

Study Design

Study Start date:
March 01, 1998
Estimated Completion Date:
November 30, 2002

Connect with a study center

  • House Ear Institute

    Los Angeles, California 90057
    United States

    Site Not Available

  • UCSD Medical Center

    San Diego, California 92103-8895
    United States

    Site Not Available

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa 52242-1078
    United States

    Site Not Available

  • Johns Hopkins Univ

    Baltimore, Maryland 21287-0008
    United States

    Site Not Available

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Univ of Michigan

    Ann Arbor, Michigan 48109-0005
    United States

    Site Not Available

  • New York University

    New York, New York
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195-5245
    United States

    Site Not Available

  • University of Texas, Southwestern Medical Center at Dallas

    Dallas, Texas
    United States

    Site Not Available

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