OTO-104 in Meniere's Disease
Research type
Research Study
Full title
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
IRAS ID
194393
Contact name
John Phillips
Contact email
Sponsor organisation
Otonomy Inc
Eudract number
2015-004496-71
Duration of Study in the UK
1 years, 6 months, 9 days
Research summary
The purpose of this study is to primarliy test the effectiveness and safety of OTO-104 (study drug) compared to placebo (inactive substance) in participants with Meniere's disease.
Meniere's disease is a rare disorder that affects the inner ear. This study will investigate whether turning OTO-104 into a gel within the ear and holding the dexamethasone in place may improve Meniere's disease symptoms.
The study will be conducted at hospital sites: male and female participants are eligible aged 18 to 85 years.
The duration of the study for each participant will be a maximum of approximately 16 weeks, including a 4 week screening period before dosing (a single injection) followed by a 12 week follow up period.
After screening (Visit 1), all eligible participants will enter into a 4-week lead-in period. During the lead-in period, participants 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 participants will be randomised to 12 mg OTO-104 (study drug) or placebo using a 1:1 allocation ratio. The randomisation is stratified by gender.
After a single intratympanic injection with OTO-104 (study drug) or placebo on Day 1, participants will continue to record their daily vertigo experience during the 12-week follow-up period. Participants will visit 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.
During the study participants will be required to give blood and urine samples, ear examinations, asked questions, use an automated voice recording system diary and complete questionnaires.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0011
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion