drugset / Trial / NCT02740387

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

NCT02740387 ↗

Phase 2 Terminated 34 enrolled Otonomy, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-06
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

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 12 mg Other

Indications