Trial Outcomes & Findings for Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy (NCT NCT03110458)
NCT ID: NCT03110458
Last Updated: 2020-10-27
Results Overview
The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
over the 4 treatment days
Results posted on
2020-10-27
Participant Flow
Participant milestones
| Measure |
SENS-111 100mg
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
34
|
|
Overall Study
COMPLETED
|
31
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Baseline characteristics by cohort
| Measure |
SENS-111 100mg
n=37 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=36 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=34 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 14.14 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
50.7 years
STANDARD_DEVIATION 13.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Body Weight
|
82.2 Kg
STANDARD_DEVIATION 22.10 • n=5 Participants
|
81.6 Kg
STANDARD_DEVIATION 18.9 • n=7 Participants
|
80.1 Kg
STANDARD_DEVIATION 16.37 • n=5 Participants
|
81.3 Kg
STANDARD_DEVIATION 18.94 • n=4 Participants
|
PRIMARY outcome
Timeframe: over the 4 treatment daysPopulation: Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients
The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
Outcome measures
| Measure |
SENS-111 100mg
n=34 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=35 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=31 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Standing Vertigo Intensity
|
165.10 mm*day
Standard Deviation 71.02
|
155.10 mm*day
Standard Deviation 83.06
|
136.60 mm*day
Standard Deviation 62.61
|
SECONDARY outcome
Timeframe: over the 4 treatment daysPopulation: Among the patients who started the study data was missing for some patients: 6 SENS-111 100mg, 4 SENS-111 200mg, 7 placebo
Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments). The vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity
Outcome measures
| Measure |
SENS-111 100mg
n=31 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=32 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=27 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Worst Spontaneous Vertigo Intensity
|
180.10 mm*day
Standard Deviation 67.20
|
170.40 mm*day
Standard Deviation 89.83
|
140.8 mm*day
Standard Deviation 64.66
|
SECONDARY outcome
Timeframe: End of treatment Day 5Population: Among the patients who started the study data was missing for some patients: 5 SENS-111 100mg, 4 SENS-111 200mg, 8 placebo patients
The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. The change from Baseline of the total score of the six conditions of the Romberg test at the end of treatment (EOT) (Day 5) is evaluated.
Outcome measures
| Measure |
SENS-111 100mg
n=32 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=32 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=26 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Proprioception D5
|
2.10 score on a scale
Standard Deviation 1.46
|
2.00 score on a scale
Standard Deviation 1.79
|
2.40 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: End of study Day 28Population: Among the patients who started the study data was missing for some patients: 7 SENS-111 100mg, 3 SENS-111 200mg, 8 placebo patients
The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. Change from Baseline of the total score of the six conditions of the Romberg test at the end of study (EOS) (Day 28) is evaluated.
Outcome measures
| Measure |
SENS-111 100mg
n=30 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=33 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=26 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Proprioception D28
|
2.70 score on a scale
Standard Deviation 1.60
|
3.00 score on a scale
Standard Deviation 1.64
|
3.20 score on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: End of treatment Day 5 compared to basleinePopulation: Among the patients who started the study data was missing for some patients: with fixation 13 SENS-111 100mg, 10 SENS-111 200mg, 11 placebo patients; without fixation 13 SENS-111 100mg, 13 SENS-111 200mg, 13 placebo patients
Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at the end of treatment (EOT) (Day 5). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).
Outcome measures
| Measure |
SENS-111 100mg
n=24 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=26 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=23 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Vestibular Spontaneous Nystagmus D5
with fixation (10 seconds)
|
-2.30 degrees per second
Standard Deviation 11.64
|
-3.50 degrees per second
Standard Deviation 10.27
|
-5.7 degrees per second
Standard Deviation 8.15
|
|
Vestibular Spontaneous Nystagmus D5
without fixation (30 seconds)
|
-1.2 degrees per second
Standard Deviation 5.77
|
-2.2 degrees per second
Standard Deviation 7.22
|
-2.7 degrees per second
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: 28 days compared to baselinePopulation: Among the patients who started the study data was missing for some patients: with fixation 11 SENS-111 100mg, 10 SENS-111 200mg, 12 placebo patients ; without fixation 12 SENS-111 100mg, 12 SENS-111 200mg, 13 placebo patients
Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at End of Study (Day 28). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).
Outcome measures
| Measure |
SENS-111 100mg
n=26 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=26 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=22 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Vestibular Spontaneous Nystagmus D28
with fixation (10 seconds)
|
-4.80 degrees per second
Standard Deviation 15.10
|
-7.9 degrees per second
Standard Deviation 12.76
|
-7.7 degrees per second
Standard Deviation 11.59
|
|
Vestibular Spontaneous Nystagmus D28
without fixation (30 seconds)
|
-0.8 degrees per second
Standard Deviation 8.84
|
-2.9 degrees per second
Standard Deviation 8.96
|
-2.7 degrees per second
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: over the 4 Treatment Days (Day 5)Population: Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients
Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS). Patients were asked to rate the intensity of their nausea making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.
Outcome measures
| Measure |
SENS-111 100mg
n=34 Participants
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=35 Participants
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=31 Participants
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Nausea Severity
|
93.00 mm*day
Standard Deviation 78.39
|
91.50 mm*day
Standard Deviation 79.73
|
92.60 mm*day
Standard Deviation 57.28
|
Adverse Events
SENS-111 100mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SENS-111 200mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SENS-111 100mg
n=36 participants at risk
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=36 participants at risk
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=32 participants at risk
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/36 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
2.8%
1/36 • Number of events 1 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
0.00%
0/32 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
Other adverse events
| Measure |
SENS-111 100mg
n=36 participants at risk
SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)
SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
|
SENS-111 200mg
n=36 participants at risk
SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)
SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
|
Placebo
n=32 participants at risk
Placebo: 2 placebo Oral Dispersible Tablets
Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Extra dose administered
|
0.00%
0/36 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
0.00%
0/36 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
6.2%
2/32 • Number of events 2 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Number of events 3 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
11.1%
4/36 • Number of events 6 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
21.9%
7/32 • Number of events 8 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/36 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
5.6%
2/36 • Number of events 2 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
0.00%
0/32 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
5.6%
2/36 • Number of events 2 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
0.00%
0/36 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
0.00%
0/32 • up to end of study 28 days
104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place