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

• Status: Terminated
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otonomy, Inc.

Criteria

Inclusion Criteria includes, but is not limited to:

• Subject has a diagnosis of definite unilateral Meniere's disease.

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

Exclusion Criteria includes, but is not limited to:

• Subject has an infection in the ear, sinuses, or upper respiratory system.

• Subject is pregnant or lactating.

• Subject has a history of immunodeficiency disease.

• Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.

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