Phase 3 Study of OTO-104 in Subjects With Unilateral 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 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Conditions
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Meniere 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-104<br> | Drug: OTO-104<br>* Single intratympanic injection of 12 mg dexamethasone<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 |
| --- | --- | --- |
| 28-Day Average DVD at Week 12 (Month 3) | The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden | The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries. | 3 Months | 
| Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit | Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit. | 3 months | 
| Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz. | Week 12 (Month 3) | 
| Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz. | Week 12 (Month 3) | 
| Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3) | The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 4000 Hz. | Week 12 (Month 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniere's Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases