OTO-104 for the Treatment of Meniere's Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Official Title
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A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Conditions
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Meniere's Disease

Intervention / Treatment
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* Drug: OTO-104
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-104<br> | Drug: OTO-104<br>* Single intratympanic injection of 12 mg OTO-104<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intratympanic injection of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertigo, Meniere's Disease, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness