OTO-104 for Meniere's Disease

Completed · Phase 1 · Has a placebo group

Conditions studied: Meniere's Disease

In brief

The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.

Key facts

Study ID

NCT01084525

Run by

Otonomy, Inc.

People needed

44

Starts

2010-03-01

Expected to finish

2011-04-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older, up to 75. 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 asymmetric low frequency sensorineural hearing loss.
• Subject agrees to maintain their current treatments for Meniere's disease while on-study.
• Subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms.
• Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

You may not qualify if…

• Subject has an infection in the ear, sinuses, or upper respiratory system.
• 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 had a duration of Meniere's disease of >20 years.

Where it is running

• House Ear Institute — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Colorado Otolaryngology Associates — Colorado Springs, Colorado, United States
• Silverstein Institute — Sarasota, Florida, United States
• Northwestern University, Feinberg School of Medicine, Otolaryngology — Chicago, Illinois, United States
• Mass Eye & Ear Infirmary — Boston, Massachusetts, United States
• University of Michigan Hospitals, Dept. of Otolaryngology — Ann Arbor, Michigan, United States
• Michigan Ear Institute — Farmington Hills, Michigan, United States
• St Louis University — St Louis, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Crescent Medical Research — Salisbury, North Carolina, United States
• Wilmington Medical Research — Wilmington, North Carolina, United States
• Piedmont Medical Research — Winston-Salem, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University Of Texas, Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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