NCT00000361

Autoimmunity in Inner Ear Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Corticosteroids
DRUG	Methotrexate

Timeline

• Start date: 1998-03-01
• Completion: 2002-11-01
• First posted: 1999-11-03
• Last updated: 2006-04-24

Locations

9 sites across 1 country: United States