Autoimmunity in Inner Ear Disease

Phase 3

Terminated

• Conditions: Hearing Loss, Sensorineural

• Registration Number: NCT00000361
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Completion: 2002-11
• Status Verified: 2006-04
• Last Update Submitted: 2006-04-21
• Last Update Posted: 2006-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (9)

University of Texas, Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

Johns Hopkins Univ; 🇺🇸 Baltimore, Maryland, United States

Univ of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

New York University; 🇺🇸 New York, New York, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Univ of Iowa Hosp and Clinic; 🇺🇸 Iowa City, Iowa, United States

House Ear Institute; 🇺🇸 Los Angeles, California, United States