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

Completed · Phase 3 · Has a placebo group

Conditions studied: Meniere Disease

In brief

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

Key facts

Study ID

NCT03664674

Run by

Otonomy, Inc.

People needed

148

Starts

2018-08-27

Expected to finish

2020-12-22

Last updated by the study team

2022-12-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado School of Medicine — Aurora, Colorado, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Ear, Nose and Throat Associates of South Florida — Boynton Beach, Florida, United States
• Ear Research Foundation — Sarasota, Florida, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Michigan Ear Institute — Farmington Hills, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Dent Neurologic Institute — Amherst, New York, United States
• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States
• Charlotte Eye Ear Nose & Throat Associates, P.A. — Matthews, North Carolina, United States
• Piedmont Ear, Nose, and Throat Associates, PA — Winston-Salem, North Carolina, United States
• Medical University of South Carolina, Department of Otolaryngology — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Intermountain Ear, Nose & Throat Specialists — Draper, Utah, United States
• West Virginia University School of Medicine — Morgantown, West Virginia, United States
• Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department — Edegem, Belgium
• UZ Gent - Ear-Nose-Throat Department — Ghent, Belgium
• UZ Leuven - Ear-Nose-Throat Department — Leuven, Belgium
• CHU de Liège - Ear-Nose-Throat Department — Liège, Belgium
• Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie — Aachen, Germany
• Praxis Bad Essen — Bad Essen, Germany
• Charité Universitätsmedizin Berlin — Berlin, Germany
• HNO Zentrum am Kudamm — Berlin, Germany
• Central California Clinical Research — Fresno, California, United States

Full record on ClinicalTrials.gov

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