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

Otonomy

Status and phase

Terminated

Phase 2

Conditions

Meniere's Disease

Treatments

Drug: OTO-104

Study type

Interventional

Funder types

Industry

Identifiers

NCT02740387

104-201505

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.