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Autoimmunity in Inner Ear Disease

NCT00000361 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-04-24

No results posted yet for this study

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.

Conditions

  • Hearing Loss, Sensorineural

Interventions

DRUG

Corticosteroids

DRUG

Methotrexate

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    lead NIH

Principal Investigators

  • Dr. Jeffrey Harris

  • Dr. Patrick Brookhouser

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Completion
2002-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000361 on ClinicalTrials.gov