A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER, PHASE 3 EFFICACY AND SAFETY STUDY OF OTO-104 GIVEN AS A SINGLE INTRATYMPANIC INJECTION IN SUBJECTS WITH UNILATERAL MENIERE?S DISEASE Save

Date Added
November 24th, 2015
PRO Number
Pro00049965
Researcher
Paul Lambert
Keywords
Ears
Summary

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.

Institution
MUSC
Recruitment Contact
John Muus
843-300-8544
muus@musc.edu

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