Meniere's Disease
Conditions
Keywords
Meniere's Disease, Vertigo, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness
Brief summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Interventions
DRUGOTO-104
Single intratympanic injection of 12 mg OTO-104
DRUGPlacebo
Single intratympanic injection of placebo
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period. * Subject has experienced active vertigo during the lead-in period. * Subject has documented asymmetric sensorineural hearing loss. * Subject agrees to maintain their current treatments for Meniere's disease while on-study. * Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.
Exclusion criteria
* 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 (IT) gentamicin in the affected ear. * Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. * Subject has experienced an adverse reaction to IT injection of steroids. * Subject has used an investigational drug or device in the 3 months prior to screening. * Subject has previously been randomized to a trial of OTO-104.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability | 4 months |
| Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living | 4 months |
| Evaluation of patient reported questionnaires as a measure of impact on patient daily activities | 4 months |
Countries
United States
Outcome results
None listed