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OTO-104 for Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01084525
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Otonomy, Inc.

Study Description
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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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ]
  3. Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ]
  4. Quality of life will be measured by patient reported questionnaire. [ Time Frame: 3 months ]
  5. Severity of vertigo episodes will be measured by the patient reported vertigo score. [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084525


Locations
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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
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Study Chair: Carl LeBel, PhD Otonomy, Inc.
More Information
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Responsible Party: Carl LeBel, PhD, Chief Scientific Officer, Otonomy, Inc
ClinicalTrials.gov Identifier: NCT01084525    
Other Study ID Numbers: 104-200901
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo
Definitive vertigo
Vertigo episodes
 Vertigo frequency
Tinnitus
Hearing loss
Aural Fullness
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases