OTO-104 for Meniere's Disease - Full Text View

Sponsor:	Otonomy, Inc.
Information provided by:	Otonomy, Inc.
ClinicalTrials.gov Identifier:	NCT01084525

Purpose

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.

Condition	Intervention	Phase
Meniere's Disease	Drug: OTO-104 (steroid) 3 mg Drug: Placebo Drug: OTO-104 (steroid) 12 mg	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Dizziness and Vertigo Meniere's Disease Tinnitus

U.S. FDA Resources

Further study details as provided by Otonomy, Inc.:

Primary Outcome Measures:

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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Quality of life will be measured by patient reported questionnaire. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Severity of vertigo episodes will be measured by the patient reported vertigo score. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	March 2010
Study Completion Date:	April 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OTO-104 (steroid) 3 mg	Drug: OTO-104 (steroid) 3 mg OTO-104 3 mg dose cohort, single intratympanic injection.
Placebo Comparator: Placebo	Drug: Placebo Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
Experimental: OTO-104 (steroid) 12 mg The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.	Drug: OTO-104 (steroid) 12 mg 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.

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084525

Locations

United States, California
House Ear Institute
Los Angeles, California, United States, 90057
University of California, San Diego
San Diego, California, United States, 92037-0970
United States, Colorado
Colorado Otolaryngology Associates
Colorado Springs, Colorado, United States, 80909
United States, Florida
Silverstein Institute
Sarasota, Florida, United States, 34239
United States, Illinois
Northwestern University, Feinberg School of Medicine, Otolaryngology
Chicago, Illinois, United States, 60611
United States, Massachusetts
Mass Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Hospitals, Dept. of Otolaryngology
Ann Arbor, Michigan, United States, 48109
Michigan Ear Institute
Farmington Hills, Michigan, United States, 48334
United States, Missouri
St Louis University
St Louis, Missouri, United States, 63110
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, North Carolina
Crescent Medical Research
Salisbury, North Carolina, United States, 28144
Wilmington Medical Research
Wilmington, North Carolina, United States, 28401
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University Of Texas, Southwestern Medical Center
Dallas, Texas, United States, 75390

Sponsors and Collaborators

Otonomy, Inc.

Investigators

Study Chair:

Carl LeBel, PhD

Otonomy, Inc.

More Information

No publications provided

Responsible Party:	Carl LeBel, PhD, Chief Scientific Officer, Otonomy, Inc
ClinicalTrials.gov Identifier:	NCT01084525 History of Changes
Other Study ID Numbers:	104-200901
Study First Received:	March 8, 2010
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otonomy, Inc.:

Meniere's Disease
Vertigo
Definitive vertigo
Vertigo episodes

Vertigo frequency
Tinnitus
Hearing loss
Aural Fullness

Additional relevant MeSH terms:

Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2012