Autoimmunity in Inner Ear Disease

This study has been terminated.

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00000361

Purpose

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	Intervention	Phase
Hearing Loss, Sensorineural	Drug: Corticosteroids Drug: Methotrexate	Phase III

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Ear Disorders Hearing Disorders and Deafness

Drug Information available for: Cyclophosphamide Methotrexate Prednisone Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Study Start Date:	March 1998
Estimated Study Completion Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000361

Locations

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)

Investigators

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

More Information

Study ID Numbers:	NIDCD-1158, UO1 DC 03209
Study First Received:	November 2, 1999
Last Updated:	April 21, 2006
ClinicalTrials.gov Identifier:	NCT00000361
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Autoimmune Diseases
Cyclophosphamide
Hearing

Labyrinth Diseases
Methotrexate
Prednisone

Study placed in the following topic categories:

Prednisone
Sensation Disorders
Autoimmune Diseases
Otorhinolaryngologic Diseases
Sensorineural hearing loss
Hearing Loss, Sensorineural
Cyclophosphamide
Ear Diseases

Folic Acid
Signs and Symptoms
Deafness
Hearing Disorders
Neurologic Manifestations
Methotrexate
Hearing Loss

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009