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 104-201102 (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.
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 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
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 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 \[Month 6\]). |
Countries
United States
Participant flow
Recruitment details
A total of 189 subjects registered for this study and signed informed consent and were enrolled. Of the 189 subjects enrolled, 49 had previously completed the 104-201102 study and 140 had previously completed the 104 201506 study. The first subject enrolled on February 16, 2016, and the last subject completed on September 9, 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, 156 subjects completed the study through Month 3 and 121 subjects completed the study through Month 6.
Participants by arm
| Arm | Count |
|---|---|
| OTO-104 Intratympanic injection of 12 mg OTO-104 | 189 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Study Terminated by Sponsor | 11 |
| Overall Study | Subject chose not to receive injection | 3 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | OTO-104 |
|---|---|
| Age, Continuous | 57.0 years |
| Duration of Meniere's disease 11-15 years | 22 Participants |
| Duration of Meniere's disease >15 years | 14 Participants |
| Duration of Meniere's disease ≤5 years | 125 Participants |
| Duration of Meniere's disease 6-10 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 1 Participants |
| Race (NIH/OMB) White | 179 Participants |
| Region of Enrollment United States | 189 participants |
| Sex: Female, Male Female | 103 Participants |
| Sex: Female, Male Male | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 189 |
| other Total, other adverse events | 30 / 189 |
| serious Total, serious adverse events | 7 / 189 |
Outcome results
Primary
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 \[Month 6\]).
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 study at the Month 6 visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: pinhole size | 4 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: ≤25% tympanic membrane | 3 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: ≤25% tympanic membrane Perforation present: >25% and ≤50% tympanic membrane | 1 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Perforation present: %50 tympanic membrane | 0 Participants |
| OTO-104 | Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) | Not Present | 113 Participants |