Overview

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.