Clinical trial NCT01084525: OTO-104 for Meniere's Disease
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meniere's Disease
Keywords: Meniere's Disease
Vertigo
Definitive vertigo
Vertigo episodes
Vertigo frequency
Tinnitus
Hearing loss
Aural Fullness
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject has experienced active vertigo during the lead-in period.
3. Subject has asymmetric low frequency sensorineural hearing loss.
4. Subject agrees to maintain their current treatments for Meniere's disease while on-study.
5. 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.
6. Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

1. Subject has an infection in the ear, sinuses, or upper respiratory system.
2. Subject is pregnant or lactating.
3. Subject has a history of immunodeficiency disease.
4. Subject has a history of previous endolymphatic sac surgery.
5. Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
6. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
7. Subject has experienced an adverse reaction to IT injection of steroids.
8. Subject has used an investigational drug or device in the 3 months prior to screening.
9. Subject has had a duration of Meniere's disease of \>20 years.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: The impact of tinnitus on activities of daily living will be measured.
timeFrame: 3 months
measure: Hearing loss in the affected ear will be measured by audiometric examination.
timeFrame: 3 months
measure: Quality of life will be measured by patient reported questionnaire.
timeFrame: 3 months
measure: Severity of vertigo episodes will be measured by the patient reported vertigo score.
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates
state: Colorado
city: Sarasota
country: United States
facility: Silverstein Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine, Otolaryngology
state: Illinois
city: Boston
country: United States
facility: Mass Eye & Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals, Dept. of Otolaryngology
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: St Louis
country: United States
facility: St Louis University
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University Of Texas, Southwestern Medical Center
state: Texas
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References: