Autoimmunity in Inner Ear Disease

April 21, 2006 updated by: National Institute on Deafness and Other Communication Disorders (NIDCD)
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
        • House Ear Institute
      • San Diego, California, United States, 92103-8895
        • UCSD Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242-1078
        • Univ of Iowa Hosp and Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21287-0008
        • Johns Hopkins Univ
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0005
        • Univ Of Michigan
    • New York
      • New York, New York, United States
        • New York University
    • Ohio
      • Cleveland, Ohio, United States, 44195-5245
        • Cleveland Clinic Foundation
    • Texas
      • Dallas, Texas, United States
        • University of Texas, Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Study Chair: Dr. Jeffrey Harris
  • Principal Investigator: Dr. Patrick Brookhouser

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Study Completion

November 1, 2002

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Estimate)

April 24, 2006

Last Update Submitted That Met QC Criteria

April 21, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCD-1158
  • U01DC003209 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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