Study Stopped
Negative Efficacy Results from the recently completed Phase 3 study 104-201506
A 6-Month Extension Study of OTO-104 in Meniere's Disease
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
1 other identifier
interventional
189
1 country
1
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 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
December 14, 2022
CompletedDecember 14, 2022
November 1, 2022
1.6 years
March 8, 2016
October 24, 2022
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 \[Month 6\]).
6 Months
Study Arms (1)
OTO-104
EXPERIMENTAL12 mg dexamethasone
Interventions
Eligibility Criteria
You may qualify if:
- Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study.
- Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria
You may not qualify if:
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has experienced an adverse reaction to intratympanic injection of steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (1)
Many sites in US. Refer to the contact info listed below.
San Diego, California, 92121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Otonomy Medical Information Center
- Organization
- Otonomy, Inc.
Study Officials
- STUDY CHAIR
Kathie Bishop, PhD
Otonomy, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 11, 2016
Study Start
February 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 14, 2022
Results First Posted
December 14, 2022
Record last verified: 2022-11