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 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 includes, but is not limited to: 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 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 (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: 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-104<br>12 mg dexamethasone | 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 |
| --- | --- | --- |
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population | In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 3 months | 
| The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population | The number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 | Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity = slight limitation = moderate limitation = sick at home = bedridden | 3 months | 
| Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 | Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity = slight limitation = moderate limitation = sick at home = bedridden | 3 months | 
| Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) | Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week12 [Month 3]). Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 3 months | 
| Audiometry - Shift in Air-Bone Gap at 500 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 (<=10 dB) to impairment (>10 dB) when measure at 500 Hz. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 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) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 3 months | 
| 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) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meniere's Disease, Vertigo