Back to resultsOpen Label Study of OTO-104 in Subjects With Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
OTO-104
Sponsored by
About this trial
This is an interventional treatment trial for Meniere's Disease
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
- Subject has a diagnosis of definite unilateral Meniere's disease.
- Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Exclusion Criteria includes, but is not limited to:
- Subject has an infection in the ear, sinuses, or upper respiratory system.
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
- Subject has experienced an adverse reaction to intratympanic injection of steroids.
Sites / Locations
- Call Otonomy call center for trial locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTO-104
Arm Description
12 mg dexamethasone
Outcomes
Primary Outcome Measures
Evaluation of adverse events as a measure of safety and tolerability
Secondary Outcome Measures
Change in hearing from baseline as assessed by audiometry
Changes in patient condition assessed by otoscopy
Changes in patient condition assessed by tympanometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02740387
Brief Title
Open Label Study of OTO-104 in Subjects With Meniere's Disease
Official Title
A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (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
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-104
Arm Type
Experimental
Arm Description
12 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
OTO-104
Other Intervention Name(s)
Single intratympanic injection 12 mg OTO-104
Primary Outcome Measure Information:
Title
Evaluation of adverse events as a measure of safety and tolerability
Time Frame
Up to 1 Year
Secondary Outcome Measure Information:
Title
Change in hearing from baseline as assessed by audiometry
Time Frame
Up to 1 Year
Title
Changes in patient condition assessed by otoscopy
Time Frame
Up to 1 Year
Title
Changes in patient condition assessed by tympanometry
Time Frame
Up to 1 Year
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 includes, but is not limited to:
Subject has a diagnosis of definite unilateral Meniere's disease.
Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Exclusion Criteria includes, but is not limited to:
Subject has an infection in the ear, sinuses, or upper respiratory system.
Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
Subject has experienced an adverse reaction to intratympanic injection of steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie Bishop, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Call Otonomy call center for trial locations
City
London
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Open Label Study of OTO-104 in Subjects With Meniere's Disease
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