Back to resultsOTO-104 for the Treatment of Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTO-104
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's Disease, Vertigo, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness
Eligibility 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 documented asymmetric sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while on-study.
- 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 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 previously been randomized to a trial of OTO-104.
Sites / Locations
- Many sites in US and Canada. Refer to the contact info listed below.
- UC Health Otolaryngology - Head and Neck Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OTO-104
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
Secondary Outcome Measures
Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01412177
Brief Title
OTO-104 for the Treatment of Meniere's Disease
Official Title
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's Disease, Vertigo, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-104
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Description
Single intratympanic injection of 12 mg OTO-104
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection of placebo
Primary Outcome Measure Information:
Title
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
Time Frame
4 months
Title
Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
Time Frame
4 months
Title
Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 documented asymmetric sensorineural hearing loss.
Subject agrees to maintain their current treatments for Meniere's disease while on-study.
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 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 previously been randomized to a trial of OTO-104.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Many sites in US and Canada. Refer to the contact info listed below.
City
San Diego
State/Province
California
Country
United States
Facility Name
UC Health Otolaryngology - Head and Neck Surgery
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Links:
URL
http://menieresresearchstudy.com
Description
Please click on this link for more information regarding this study and referral to the closest study site if you qualify (http://menieresresearchstudy.com).
Learn more about this trial
OTO-104 for the Treatment of Meniere's Disease
We'll reach out to this number within 24 hrs