Clinical trial NCT00000361: Autoimmunity in Inner Ear Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hearing Loss, Sensorineural
Keywords: Autoimmune Diseases
Cyclophosphamide
Hearing
Labyrinth Diseases
Methotrexate
Prednisone
Lead sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sponsor class: NIH
First posted: 1999-11-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Iowa City
country: United States
facility: Univ of Iowa Hosp and Clinic
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Univ
state: Maryland
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: Univ of Michigan
state: Michigan
city: New York
country: United States
facility: New York University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center at Dallas
state: Texas
Study officials:
name: Dr. Jeffrey Harris
role: STUDY_CHAIR
name: Dr. Patrick Brookhouser
role: PRINCIPAL_INVESTIGATOR
References: