Meniere's Disease
Conditions
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.
Interventions
DRUGOTO-104
Single intratympanic injection of 12 mg OTO-104
Sponsors
Otonomy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | 6 Months | 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 \[Month 6\]). |
Countries
United States
Participant flow
Recruitment details
A total of 142 subjects were enrolled. Of the 142 subjects enrolled, 46 had previously completed the 104-201403 study and 96 had previously completed the 104 201508 study. The first subject enrolled on August 25, 2016, and the last subject completed on September 8, 2017.
Pre-assignment details
This study was terminated early based on results of study 104-201506, a US Phase 3 study that indicated no statistically significant difference in the primary endpoint of reduction in definitive vertigo days (DVD) for OTO-104 vs placebo nor for any of the secondary endpoints. Decision was made to terminate all ongoing studies on August 31, 2017, including this study. At the time of termination, 90 subjects completed the study through Month 3 and 56 subjects completed the study through Month 6.
Participants by arm
| Arm | Count |
|---|---|
| OTO-104 12 mg dexamethasone
OTO-104: Intratympanic injection of 12 mg OTO-104 | 142 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Study terminated by Sponsor | 78 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | OTO-104 |
|---|---|
| Age, Continuous | 53.0 years |
| Duration of Meniere's Disease 11-15 years | 8 Participants |
| Duration of Meniere's Disease >15 years | 7 Participants |
| Duration of Meniere's Disease ≤5 years | 109 Participants |
| Duration of Meniere's Disease 6-10 years | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 136 Participants |
| Region of Enrollment Belgium | 6 participants |
| Region of Enrollment France | 4 participants |
| Region of Enrollment Germany | 17 participants |
| Region of Enrollment Italy | 9 participants |
| Region of Enrollment Poland | 23 participants |
| Region of Enrollment United Kingdom | 83 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 142 |
| other Total, other adverse events | 37 / 142 |
| serious Total, serious adverse events | 4 / 142 |
Outcome results
Primary
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 \[Month 6\]).
Time frame: 6 Months
Population: The 6-month Safety Analysis Set included all subjects who received at least 1 dose of study drug and completed the Month 6 visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation not present | 56 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation information missing | 0 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: pinhole size | 0 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: ≤25% tympanic membrane | 0 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: >25% and ≤50% tympanic membrane | 0 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: >50% tympanic membrane | 0 Participants |