Autoimmunity in Inner Ear Disease - Full Text View

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

ChemIDplus related topics:

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
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 August 27, 2008