OTO-104 for Meniere's Disease

Meniere's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084525
• Other study ID #: 104-200901
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2010
• Last updated: June 7, 2011
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• OTO-104 (steroid) 3 mg
OTO-104 3 mg dose cohort, single intratympanic injection.
• Placebo
Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospitals, Dept. of Otolaryngology	Ann Arbor	Michigan
United States	Mass Eye & Ear Infirmary	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University, Feinberg School of Medicine, Otolaryngology	Chicago	Illinois
United States	Colorado Otolaryngology Associates	Colorado Springs	Colorado
United States	University Of Texas, Southwestern Medical Center	Dallas	Texas
United States	Michigan Ear Institute	Farmington Hills	Michigan
United States	House Ear Institute	Los Angeles	California
United States	New York Eye and Ear Infirmary	New York	New York
United States	Crescent Medical Research	Salisbury	North Carolina
United States	University of California, San Diego	San Diego	California
United States	Silverstein Institute	Sarasota	Florida
United States	St Louis University	St Louis	Missouri
United States	Wilmington Medical Research	Wilmington	North Carolina
United States	Piedmont Medical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	The impact of tinnitus on activities of daily living will be measured.		3 months	No
Secondary	Hearing loss in the affected ear will be measured by audiometric examination.		3 months	No
Secondary	Quality of life will be measured by patient reported questionnaire.		3 months	No
Secondary	Severity of vertigo episodes will be measured by the patient reported vertigo score.		3 months	No