Study of OTO-104 in Subjects With Unilateral Meniere's Disease

• Status: Terminated
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otonomy, Inc.

Criteria

Inclusion Criteria includes, but is not limited to:

• Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.

• Subject has experienced active vertigo during the lead-in period.

• Subject has documented asymmetric sensorineural hearing loss.

• Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

• Subject is pregnant or lactating.

• Subject has a history of immunodeficiency disease.

• Subject has a history of previous endolymphatic sac surgery.

• Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.

• Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.

• Subject has experienced an adverse reaction to IT injection of steroids.

• Subject has used an investigational drug or device in the 3 months prior to screening.

• Subject has previously been randomized to a trial of OTO-104.