OTO-104 for Meniere's Disease
- Conditions
- Meniere's Disease
- Interventions
- Drug: OTO-104 (steroid) 3 mgDrug: PlaceboDrug: OTO-104 (steroid) 12 mg
- Registration Number
- NCT01084525
- Lead Sponsor
- Otonomy, Inc.
- Brief Summary
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.
- Detailed Description
Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Meniere's disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTO-104 (steroid) 3 mg OTO-104 (steroid) 3 mg - Placebo Placebo - OTO-104 (steroid) 12 mg OTO-104 (steroid) 12 mg The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo. 3 months
- Secondary Outcome Measures
Name Time Method Hearing loss in the affected ear will be measured by audiometric examination. 3 months The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics. 3 months The impact of tinnitus on activities of daily living will be measured. 3 months Quality of life will be measured by patient reported questionnaire. 3 months Severity of vertigo episodes will be measured by the patient reported vertigo score. 3 months
Trial Locations
- Locations (15)
Colorado Otolaryngology Associates
🇺🇸Colorado Springs, Colorado, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
House Ear Institute
🇺🇸Los Angeles, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Silverstein Institute
🇺🇸Sarasota, Florida, United States
Northwestern University, Feinberg School of Medicine, Otolaryngology
🇺🇸Chicago, Illinois, United States
Michigan Ear Institute
🇺🇸Farmington Hills, Michigan, United States
University Of Texas, Southwestern Medical Center
🇺🇸Dallas, Texas, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
St Louis University
🇺🇸St Louis, Missouri, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
University of Michigan Hospitals, Dept. of Otolaryngology
🇺🇸Ann Arbor, Michigan, United States
Mass Eye & Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States