Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease



Status:Recruiting
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:August 27, 2018
End Date:May 2020
Contact:Clinical Study Manager
Email:otonomyclinicaltrials@otonomy.com

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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

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


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.
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Aurora, Colorado 80045
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1211 Medical Center Dr
Nashville, Tennessee 37232
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333 Cedar St
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