OTO-104 in Meniere's Disease
Research type
Research Study
Full title
A 6-month, prospective, randomized, multicenter, placebo-controlled safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere's disease, followed by a 6-month open-label extension
IRAS ID
156001
Contact name
John Phillips
Contact email
Sponsor organisation
Otonomy Inc.
Eudract number
2014-001337-86
Research summary
The proposed study in Meniere’s disease patients is designed to assess the safety of repeat doses of OTO-104 in patients who have failed the usual standard of care (SOC) medical management or are currently on the SOC. The study is separated into two parts. Part A of this study is a 6-month double-blind safety phase in which eligible subjects with unilateral Meniere’s disease will be randomised to receive either placebo or 12 mg OTO-104, given as a single intratympanic (IT) injection at 3-month intervals for a total of two injections. After subjects successfully complete the double-blind safety phase, subjects will be eligible to participate in Part B, which is a 6-month open-label extension phase where subjects will receive a single IT injection of 12 mg OTO-104 at 3-month intervals for a total of two injections. All subjects will be maintained on standard of care treatment for both Part A and Part B of the study.
REC name
East of England - Essex Research Ethics Committee
REC reference
14/EE/1001
Date of REC Opinion
11 Jul 2014
REC opinion
Further Information Favourable Opinion