Meniere's Disease
Conditions
Brief summary
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.
Interventions
DRUGOTO-104
DRUGPlacebo
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject has a diagnosis of definite unilateral Meniere's disease. * Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Exclusion criteria
includes, but is not limited to: * Subject is pregnant or lactating. * Subject has a history of immunodeficiency disease. * Subject has a history of previous endolymphatic sac surgery. * Subject has a history of previous use of intratympanic gentamicin in the affected ear. * Subject has a history of drop attacks. * Subject has experienced an adverse reaction to intratympanic injection of steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Up to 1 Year | Otoscopy, audiometry, tympanometry, adverse events |
Secondary
| Measure | Time frame |
|---|---|
| Meniere's Symptom Questionnaire | Up to 1 Year |
Countries
United Kingdom
Outcome results
None listed