A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
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.