Trial Outcomes & Findings for A 6-Month Extension Study of OTO-104 in Meniere's Disease (NCT NCT02768662)
NCT ID: NCT02768662
Last Updated: 2023-01-20
Results Overview
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 \[Month 6\]).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
142 participants
Primary outcome timeframe
6 Months
Results posted on
2023-01-20
Participant Flow
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.
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.
Participant milestones
| Measure |
OTO-104
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Overall Study
STARTED
|
142
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
86
|
Reasons for withdrawal
| Measure |
OTO-104
Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Study terminated by Sponsor
|
78
|
Baseline Characteristics
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Baseline characteristics by cohort
| Measure |
OTO-104
n=142 Participants
12 mg dexamethasone
OTO-104: Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Age, Continuous
|
53.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
23 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
83 participants
n=5 Participants
|
|
Duration of Meniere's Disease
≤5 years
|
109 Participants
n=5 Participants
|
|
Duration of Meniere's Disease
6-10 years
|
18 Participants
n=5 Participants
|
|
Duration of Meniere's Disease
11-15 years
|
8 Participants
n=5 Participants
|
|
Duration of Meniere's Disease
>15 years
|
7 Participants
n=5 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 Month 6 visit
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 \[Month 6\]).
Outcome measures
| Measure |
OTO-104
n=56 Participants
12 mg dexamethasone
OTO-104: Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation information missing
|
0 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: pinhole size
|
0 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: ≤25% tympanic membrane
|
0 Participants
|
|
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Perforation present: >25% and ≤50% tympanic membrane
|
0 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)
Perforation not present
|
56 Participants
|
Adverse Events
OTO-104
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OTO-104
n=142 participants at risk
12 mg dexamethasone
OTO-104: Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain and Constipation
|
0.70%
1/142 • Number of events 1 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.70%
1/142 • Number of events 1 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Blood and lymphatic system disorders
Anemia
|
0.70%
1/142 • Number of events 1 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.70%
1/142 • Number of events 1 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
Other adverse events
| Measure |
OTO-104
n=142 participants at risk
12 mg dexamethasone
OTO-104: Intratympanic injection of 12 mg OTO-104
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Infections and infestations
Urinary Tract Infection
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Ear and labyrinth disorders
Tinnitus
|
3.5%
5/142 • Number of events 5 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
4/142 • Number of events 4 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Ear and labyrinth disorders
Meniere's Disease
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Nervous system disorders
Headache
|
2.8%
4/142 • Number of events 4 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Nervous system disorders
Dizziness
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
General disorders
Injection Site Discomfort
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
|
Injury, poisoning and procedural complications
Procedural Dizziness
|
2.1%
3/142 • Number of events 3 • Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60