OTO-104 for Meniere's Disease
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
1 other identifier
interventional
44
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2010
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 8, 2011
June 1, 2011
1 year
March 8, 2010
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Hearing loss in the affected ear will be measured by audiometric examination.
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
Study Arms (3)
OTO-104 (steroid) 3 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATOROTO-104 (steroid) 12 mg
EXPERIMENTALThe start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
Interventions
OTO-104 3 mg dose cohort, single intratympanic injection.
Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (15)
House Ear Institute
Los Angeles, California, 90057, United States
University of California, San Diego
San Diego, California, 92037-0970, United States
Colorado Otolaryngology Associates
Colorado Springs, Colorado, 80909, United States
Silverstein Institute
Sarasota, Florida, 34239, United States
Northwestern University, Feinberg School of Medicine, Otolaryngology
Chicago, Illinois, 60611, United States
Mass Eye & Ear Infirmary
Boston, Massachusetts, 02114, United States
University of Michigan Hospitals, Dept. of Otolaryngology
Ann Arbor, Michigan, 48109, United States
Michigan Ear Institute
Farmington Hills, Michigan, 48334, United States
St Louis University
St Louis, Missouri, 63110, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Wilmington Medical Research
Wilmington, North Carolina, 28401, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University Of Texas, Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carl LeBel, PhD
Otonomy, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 10, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
June 8, 2011
Record last verified: 2011-06