Back to resultsA 6-Month Extension Study of OTO-104 in Meniere's Disease
Primary Purpose
Meniere's Disease
Status
Terminated
Phase
Phase 3
Locations
United States
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 completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
- Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria
Exclusion Criteria includes, but is not limited to:
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has experienced an adverse reaction to intratympanic injection of steroids.
Sites / Locations
- Many sites in Europe. Refer to the contact info listed below.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTO-104
Arm Description
12 mg dexamethasone
Outcomes
Primary Outcome Measures
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02768662
Brief Title
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Official Title
A 6-Month, Multicenter, Phase 3, Open-Label Extension 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
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Study Start Date
August 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
No
5. Study Description
Brief Summary
This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
142 (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
Intervention Description
Single intratympanic injection of 12 mg OTO-104
Primary Outcome Measure Information:
Title
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Description
Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria includes, but is not limited to:
Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria
Exclusion Criteria includes, but is not limited to:
Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
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
Many sites in Europe. Refer to the contact info listed below.
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 6-Month Extension Study of OTO-104 in Meniere's Disease
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