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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Heatherwood & Wexham Park Hospitals
Berkshire, United Kingdom
Birmingham University Hospital
Birmingham, United Kingdom
BMI The Edgbaston Hospital
Birmingham, United Kingdom
Safety
Otoscopy, audiometry, tympanometry, adverse events
Time frame: Up to 1 Year
Meniere's Symptom Questionnaire
Time frame: Up to 1 Year
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Southmead Hospital Bristol
Bristol, United Kingdom
Oxford University Hospitals
Bucks, United Kingdom
Cambridge University Hospitals
Cambridge, United Kingdom
Dorset County Hospital
Dorset, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Leicester Royal Infirmary
Leicestershire, United Kingdom
Guy's Hospital and St. Thomas' Hospital
London, United Kingdom
...and 5 more locations