Trial Outcomes & Findings for A 6-Month Extension Study of OTO-104 in Meniere's Disease (NCT NCT02706730)
NCT ID: NCT02706730
Last Updated: 2022-12-14
Results Overview
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 \[Month 6\]).
TERMINATED
PHASE3
189 participants
6 Months
2022-12-14
Participant Flow
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.
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.
Participant milestones
| Measure |
OTO-104
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
OTO-104
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Study Terminated by Sponsor
|
11
|
|
Overall Study
Subject chose not to receive injection
|
3
|
Baseline Characteristics
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Baseline characteristics by cohort
| Measure |
OTO-104
n=189 Participants
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Age, Continuous
|
57.0 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=93 Participants
|
|
Duration of Meniere's disease
≤5 years
|
125 Participants
n=93 Participants
|
|
Duration of Meniere's disease
6-10 years
|
28 Participants
n=93 Participants
|
|
Duration of Meniere's disease
11-15 years
|
22 Participants
n=93 Participants
|
|
Duration of Meniere's disease
>15 years
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: 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.
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 \[Month 6\]).
Outcome measures
| Measure |
OTO-104
n=121 Participants
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: pinhole size
|
4 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: ≤25% tympanic membrane
|
3 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: ≤25% tympanic membrane Perforation present: >25% and ≤50% tympanic membrane
|
1 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: %50 tympanic membrane
|
0 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Not Present
|
113 Participants
|
Adverse Events
OTO-104
Serious adverse events
| Measure |
OTO-104
n=189 participants at risk
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Nervous system disorders
Hemiplegic Migraine
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Gastrointestinal disorders
Omental Infarction and Small Intestinal Obstruction
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Cardiac disorders
Angina Pectoris
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Ear and labyrinth disorders
Deafness, Unilateral
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.53%
1/189 • Number of events 1 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
Other adverse events
| Measure |
OTO-104
n=189 participants at risk
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
7/189 • Number of events 7 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
6/189 • Number of events 6 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Ear and labyrinth disorders
Ear Pain
|
2.1%
4/189 • Number of events 4 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
2.1%
4/189 • Number of events 4 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Nervous system disorders
Dizziness
|
2.6%
5/189 • Number of events 5 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
|
Psychiatric disorders
Suicidal Ideation
|
2.1%
4/189 • Number of events 4 • Reported or observed during or after dosing with the study drug up until end of study (Month 6).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60