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

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.

Timeline

Start

2016-08

Primary completion

2017-09

Completion

2017-09

Outcome

Outcome not reported

Stopped: “Negative Efficacy Results from the recently completed Phase 3 study 104-201506”

Drugs

Indications