Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Purpose
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Condition
- Meniere Disease
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts 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.
Exclusion Criteria
- Subject is pregnant or lactating. - Subject has a history of immunodeficiency disease. - Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear. - Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. - Subject has a history of vestibular migraine. - Subject has used an investigational drug or device in the 3 months prior to screening. - Subject has previously been randomized to a clinical study of OTO-104.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, Double-blind, Placebo-controlled, Multicenter
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental OTO-104 |
|
|
|
Placebo Comparator placebo |
|
More Details
- Status
- Completed
- Sponsor
- Otonomy, Inc.