Autoimmunity in Inner Ear Disease

Hearing Loss, Sensorineural Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000361
• Other study ID #: NIDCD-1158
• Secondary ID: UO1 DC 03209
• Status: Terminated
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: April 21, 2006
• Start date: March 1998
• Est. completion date: November 2002

Study information

• Verified date: April 2006
• Source: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• Corticosteroids

• Methotrexate

Locations

Country	Name	City	State
United States	Univ of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Univ	Baltimore	Maryland
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas, Southwestern Medical Center at Dallas	Dallas	Texas
United States	Univ of Iowa Hosp and Clinic	Iowa City	Iowa
United States	House Ear Institute	Los Angeles	California
United States	New York University	New York	New York
United States	UCSD Medical Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States,