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

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.

Study Overview

• Status: Completed
• Conditions: Meniere's Disease
• Intervention / Treatment: Drug: OTO-104 (steroid) 3 mg; Drug: Placebo; Drug: OTO-104 (steroid) 12 mg

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
EXPERIMENTAL: OTO-104 (steroid) 3 mg	Drug: OTO-104 (steroid) 3 mg; OTO-104 3 mg dose cohort, single intratympanic injection.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (ESTIMATE): March 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2011
• Last Update Submitted That Met QC Criteria: June 7, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Vertigo; Tinnitus; Hearing loss; Meniere's Disease; Definitive vertigo; Vertigo episodes; Vertigo frequency; Aural Fullness
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Meniere Disease
• Other Study ID Numbers: 104-200901