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.
We found this trial at
15
sites
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-2491
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Amherst, New York 14226
Phone: 716-558-3488
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Aurora, Colorado 80045
Phone: 303-724-9528
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Bad Essen, 49152
Phone: (+49) 05472 3400
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Boynton Beach, Florida 33426
Phone: 561-737-8584
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Charleston, South Carolina 29425
Phone: 843-792-1356
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Colorado Springs, Colorado 80909
Phone: 719-867-7810
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Farmington Hills, Michigan 48833
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Fresno, California 93720
Phone: 559-432-3303
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Matthews, North Carolina 28105
Phone: 704-295-3390
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Morgantown, West Virginia 26506
Phone: 304-598-6135
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-584-8404
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Saint Louis, Missouri 63110
Phone: 314-268-7407
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Sarasota, Florida 34239
Phone: 941-366-9222
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Winston-Salem, North Carolina 27103
Phone: 336-768-3361
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