Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting (NCT NCT03021018)
NCT ID: NCT03021018
Last Updated: 2020-12-16
Results Overview
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram \[EEG\] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)
Results posted on
2020-12-16
Participant Flow
The study started to enroll patients in February 2017 and concluded in April 2018.
Participant Flow refers to the Intent-to-Treat as Treated (ITT-T) Set.
Participant milestones
| Measure |
Lorazepam (LZP)
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.
|
Brivaracetam (BRV) 100 mg
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.
|
Brivaracetam (BRV) 200 mg
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lorazepam (LZP)
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.
|
Brivaracetam (BRV) 100 mg
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.
|
Brivaracetam (BRV) 200 mg
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Fall with subsequent nasal fracture
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Baseline characteristics by cohort
| Measure |
Lorazepam (LZP)
n=16 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The lorazepam (LZP) dose was determined according to the Investigator's clinical judgment.
|
Brivaracetam (BRV) 100 mg
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period.
|
Brivaracetam (BRV) 200 mg
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period.
|
Total Title
n=46 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
41.10 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
43.92 years
STANDARD_DEVIATION 12.41 • n=7 Participants
|
41.59 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
42.18 years
STANDARD_DEVIATION 13.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)Population: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram \[EEG\] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication
|
NA hours
Interval 5.55 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
NA hours
Interval 6.93 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
NA hours
Interval 4.33 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
SECONDARY outcome
Timeframe: During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)Population: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram \[EEG\]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Time to Next Seizure (Per Clinical Observation) or Rescue Medication
|
NA hours
Interval 5.55 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
NA hours
Interval 6.93 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
NA hours
Interval 4.33 to
Due to the low numbers of events seen in the study, the Upper Confidence Limit (UCL) was not calculable.
|
SECONDARY outcome
Timeframe: At 6 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration
|
73.3 percentage of participants
|
86.7 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: At 8 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration
|
73.3 percentage of participants
|
80.0 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration
|
60.0 percentage of participants
|
80.0 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: During the 6 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration
|
20.0 percentage of participnats
|
0 percentage of participnats
|
6.7 percentage of participnats
|
SECONDARY outcome
Timeframe: During the 8 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration
|
26.7 percentage of participants
|
6.7 percentage of participants
|
13.3 percentage of participants
|
SECONDARY outcome
Timeframe: During the 12 hours after the end of study drug administrationPopulation: The Intent-to-Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.
Outcome measures
| Measure |
Lorazepam (LZP) (ITT-R)
n=15 Participants
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Randomized (ITT-R) Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 100 mg (ITT-R)
n=15 Participants
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
Brivaracetam (BRV) 200 mg (ITT-R)
n=15 Participants
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-R Set which consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.
|
|---|---|---|---|
|
Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration
|
40.0 percentage of participnats
|
6.7 percentage of participnats
|
13.3 percentage of participnats
|
Adverse Events
Lorazepam (LZP) (ITT-T)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Brivaracetam (BRV) 100 mg (ITT-T)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Brivaracetam (BRV) 200 mg (ITT-T)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorazepam (LZP) (ITT-T)
n=16 participants at risk
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Treated (ITT-T) Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
Brivaracetam (BRV) 100 mg (ITT-T)
n=15 participants at risk
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
Brivaracetam (BRV) 200 mg (ITT-T)
n=15 participants at risk
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
|---|---|---|---|
|
Nervous system disorders
Seizure cluster
|
6.2%
1/16 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
Other adverse events
| Measure |
Lorazepam (LZP) (ITT-T)
n=16 participants at risk
Lorazepam bolus was injected based on information from the patient leaflet/package insert. The LZP dose was determined according to the Investigator's clinical judgment. Subjects formed the Intent-to-Treat as Treated (ITT-T) Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
Brivaracetam (BRV) 100 mg (ITT-T)
n=15 participants at risk
Two 5 ml vials of brivaracetam administered intravenously over a 2-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
Brivaracetam (BRV) 200 mg (ITT-T)
n=15 participants at risk
Four 5 ml vials of brivaracetam administered intravenously over a 4-minute period. Subjects formed the ITT-T Set which consisted of subjects who were treated with investigational medicinal product (IMP) regardless of qualifying seizure status.
|
|---|---|---|---|
|
General disorders
Vessel puncture site pain
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
20.0%
3/15 • Number of events 3 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
13.3%
2/15 • Number of events 2 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
13.3%
2/15 • Number of events 2 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
13.3%
2/15 • Number of events 2 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Sedation
|
12.5%
2/16 • Number of events 2 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
6.7%
1/15 • Number of events 1 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
|
Nervous system disorders
Somnolence
|
12.5%
2/16 • Number of events 2 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
0.00%
0/15 • From Screening, at Day -28 and up to Safety Follow-Up (24 hours after the end of drug administration).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60