Autoimmunity in Inner Ear Disease

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ClinicalTrials.gov Identifier: NCT00000361

Recruitment Status : Terminated

First Posted : November 3, 1999

Last Update Posted : April 24, 2006

Sponsor:

Information provided by:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Description

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

Study Design

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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

MedlinePlus Genetics related topics: Nonsyndromic hearing loss

MedlinePlus related topics: Ear Disorders Hearing Disorders and Deafness

Drug Information available for: Methotrexate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00000361

Locations

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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

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

More Information

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ClinicalTrials.gov 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 Cyclophosphamide Hearing	Labyrinth Diseases Methotrexate Prednisone

Additional relevant MeSH terms:

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Hearing Loss Hearing Loss, Sensorineural Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents	Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors

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