OTO-104 for Meniere's Disease

• ClinicalTrials.gov Identifier: NCT01084525
• Recruitment Status: Completed
• First Posted: March 10, 2010
• Last Update Posted: June 8, 2011
• Sponsor: Otonomy, Inc.
• Information provided by: Otonomy, Inc.

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

• 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
• 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:

Meniere Disease; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases