Working… Menu

Autoimmunity in Inner Ear Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000361
Recruitment Status : Terminated
First Posted : November 3, 1999
Last Update Posted : April 24, 2006
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 1998
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000361

Layout table for location information
United States, California
House Ear Institute
Los Angeles, California, United States, 90057
UCSD Medical Center
San Diego, California, United States, 92103-8895
United States, Iowa
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States, 52242-1078
United States, Maryland
Johns Hopkins Univ
Baltimore, Maryland, United States, 21287-0008
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
United States, Michigan
Univ of Michigan
Ann Arbor, Michigan, United States, 48109-0005
United States, New York
New York University
New York, New York, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195-5245
United States, Texas
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas, United States
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Layout table for investigator information
Study Chair: Dr. Jeffrey Harris
Principal Investigator: Dr. Patrick Brookhouser
Layout table for additonal information Identifier: NCT00000361    
Other Study ID Numbers: NIDCD-1158
U01DC003209 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: April 24, 2006
Last Verified: April 2006
Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Autoimmune Diseases
Labyrinth Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors