A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

Otonomy

Status and phase: Completed; Phase 2

Conditions: Meniere's Disease

Treatments: Drug: OTO-104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02265393

104-201403

Details and patient eligibility

About

This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

Enrollment: 128 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 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 gentamicin in the affected ear.
• Subject has a history of drop attacks.
• Subject has experienced an adverse reaction to intratympanic injection of steroids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

OTO-104

Active Comparator group

Description:

12 mg OTO-104 (dexamethasone)

Treatment:

Drug: OTO-104

Placebo

Placebo Comparator group

Description:

OTO-104 vehicle

Treatment:

Drug: Placebo