This is a randomized, double blind, placebo-controlled, multicenter 16-week Phase 3 study. Following an initial 4-week lead-in period, eligible subjects will be randomly assigned to either 12 mg OTO-104 or placebo using a 1:1 allocation ratio stratified by gender. Subjects will be observed for 12 weeks following a single intratympanic injection of either 12 mg OTO-104 or placebo.
The duration of the study for each subject will be a maximum of approximately 16 weeks, including a 4-week lead-in period before dosing (a single injection), followed by a 12-week follow-up period.
After screening (Visit 1), all eligible subjects will enter into a 4-week lead-in period. During the lead-in period, subjects will record their daily vertigo experience to allow for a baseline assessment of these events. Any day with a recorded definitive vertigo episode, an episode lasting at least 20 minutes (corresponding to a Vertigo Severity Score of 2 or more), will be defined as a definitive vertigo day (DVD). Following the lead-in period, eligible subjects will be randomized to 12 mg OTO-104 or placebo using a 1:1 allocation ratio.
After a single intratympanic injection with OTO-104 or placebo on Day 1, subjects will continue to record their daily vertigo experience during the 12-week follow-up period. Subjects will visit the study site at Weeks 4 and 8 for additional efficacy and safety assessments. Efficacy and safety assessments will also be completed at the end of study (Week 12) or upon early discontinuation from the study.