A 6-Month Extension Study of OTO-104 in Meniere's Disease

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

Summary

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

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

Details

• Lead Sponsor: Otonomy, Inc.

Criteria

Inclusion Criteria includes, but is not limited to:

• Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.

• Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

• Subject is pregnant or lactating.

• Subject has a history of immunodeficiency disease.

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