Trial Outcomes & Findings for Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures (NCT NCT00464269)
NCT ID: NCT00464269
Last Updated: 2022-07-21
Results Overview
Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Baseline to 12-week Treatment Period
Results posted on
2022-07-21
Participant Flow
This study started to enroll subjects in September 2007 and concluded in January 2009. 400 subjects were randomized of which 396 are included in the Safety Population.
Participant Flow refers to the Randomized Set (RS).
Participant milestones
| Measure |
Placebo
Matching Placebo tablets administered twice a day
|
BRV 5 mg/Day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
BRV 20 mg/Day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
BRV 50 mg/Day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
99
|
99
|
100
|
102
|
|
Overall Study
COMPLETED
|
93
|
82
|
93
|
93
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
7
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo tablets administered twice a day
|
BRV 5 mg/Day
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
BRV 20 mg/Day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
BRV 50 mg/Day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
1
|
|
Overall Study
Other reason
|
3
|
3
|
1
|
1
|
|
Overall Study
AE, serious fatal
|
0
|
0
|
1
|
1
|
|
Overall Study
SAE, non-fatal
|
0
|
0
|
0
|
1
|
|
Overall Study
AE, non-serious non-fatal
|
2
|
8
|
3
|
4
|
|
Overall Study
SAE,non-fatal+AE,non-serious non-fatal
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Placebo
n=99 Participants
Matching Placebo tablets administered twice a day
|
BRV 5 mg/Day
n=99 Participants
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
BRV 20 mg/Day
n=100 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
BRV 50 mg/Day
n=102 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Total Title
n=400 Participants
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
38.2 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
|
Age, Customized
< 18 years
|
7 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Age, Customized
18 - < 65 years
|
91 participants
n=5 Participants
|
97 participants
n=7 Participants
|
93 participants
n=5 Participants
|
99 participants
n=4 Participants
|
380 participants
n=21 Participants
|
|
Age, Customized
65 - < 85 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
198 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Partial (Type I) seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
|
2.15 seizures per week
Interval 1.43 to 4.15
|
1.80 seizures per week
Interval 0.99 to 5.59
|
1.96 seizures per week
Interval 1.05 to 5.45
|
1.70 seizures per week
Interval 0.91 to 4.8
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Responders
|
16 participants
|
21 participants
|
23 participants
|
33 participants
|
|
Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
Non-responders
|
80 participants
|
75 participants
|
76 participants
|
68 participants
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
There are three different types of seizures: * Type I: Partial seizures * Type II: Generalized seizures * Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)\*7/(Total number of days with no missing seizure count in the TP)
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
|
2.15 seizures per week
Interval 1.45 to 4.23
|
1.80 seizures per week
Interval 0.99 to 5.59
|
1.96 seizures per week
Interval 1.05 to 5.85
|
1.77 seizures per week
Interval 0.99 to 4.8
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Percent change from Baseline was calculated as percent reduction by: (weekly seizure frequency Baseline - weekly seizure frequency Treatment)\*100/(weekly seizure frequency Baseline). The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=95 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
|
17.75 Percent change in POS frequency
Interval -5.11 to 37.07
|
19.95 Percent change in POS frequency
Interval -12.96 to 45.15
|
22.52 Percent change in POS frequency
Interval -4.56 to 46.51
|
30.47 Percent change in POS frequency
Interval 11.4 to 59.78
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: \<-25 %, -25 % to \<25 %, 25 % to \<50 %, 50 % to \<75 %, 75 % to \<100 %, and 100 %. Subjects having zero for Baseline seizure frequency per week were classified in the \<-25 % category.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
<-25 %
|
14.6 percentage of participants
|
21.9 percentage of participants
|
14.1 percentage of participants
|
9.9 percentage of participants
|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
-25 % to < 25 %
|
44.8 percentage of participants
|
31.3 percentage of participants
|
38.4 percentage of participants
|
31.7 percentage of participants
|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
25 % to < 50 %
|
24.0 percentage of participants
|
25.0 percentage of participants
|
24.2 percentage of participants
|
25.7 percentage of participants
|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
50 % to < 75 %
|
12.5 percentage of participants
|
12.5 percentage of participants
|
15.2 percentage of participants
|
19.8 percentage of participants
|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
75 % to < 100 %
|
4.2 percentage of participants
|
8.3 percentage of participants
|
6.1 percentage of participants
|
8.9 percentage of participants
|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
100 %
|
0 percentage of participants
|
1.0 percentage of participants
|
2.0 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as: (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Seizure-free
|
0 percentage of participants
|
1.0 percentage of participants
|
1.0 percentage of participants
|
4.0 percentage of participants
|
|
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
No seizures but non-completer
|
0 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
0 percentage of participants
|
|
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Not seizure-free
|
100.0 percentage of participants
|
99.0 percentage of participants
|
98.0 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Time to First Type I Seizure During the 12-week Treatment Period
|
3 days
Interval 2.0 to 3.0
|
4 days
Interval 2.0 to 5.0
|
5 days
Interval 3.0 to 7.0
|
4 days
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Time to Fifth Type I Seizure During the 12-week Treatment Period
|
15 days
Interval 12.0 to 16.0
|
14 days
Interval 12.0 to 18.0
|
17 days
Interval 14.0 to 21.0
|
19 days
Interval 16.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=96 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=96 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=101 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Time to Tenth Type I Seizure During the 12-week Treatment Period
|
28 days
Interval 24.0 to 33.0
|
30 days
Interval 21.0 to 38.0
|
34 days
Interval 25.0 to 46.0
|
37 days
Interval 27.0 to 52.0
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication. Type IC Population consists of those subjects with at least one Type IC seizure during the Baseline period.
The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=32 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=34 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=36 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=33 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period
|
56.3 percentage of participants
|
50.0 percentage of participants
|
77.8 percentage of participants
|
63.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=86 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=81 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=81 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=85 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
3.88 units on a scale
Standard Deviation 14.44
|
4.07 units on a scale
Standard Deviation 15.40
|
5.19 units on a scale
Standard Deviation 15.47
|
2.88 units on a scale
Standard Deviation 13.53
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
9.36 units on a scale
Standard Deviation 26.98
|
3.34 units on a scale
Standard Deviation 19.20
|
3.69 units on a scale
Standard Deviation 24.55
|
5.97 units on a scale
Standard Deviation 21.79
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=87 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
1.97 units on a scale
Standard Deviation 28.39
|
7.03 units on a scale
Standard Deviation 23.47
|
7.73 units on a scale
Standard Deviation 26.04
|
2.06 units on a scale
Standard Deviation 23.02
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
|
7.44 units on a scale
Standard Deviation 4.32
|
7.32 units on a scale
Standard Deviation 4.03
|
6.55 units on a scale
Standard Deviation 3.94
|
7.99 units on a scale
Standard Deviation 3.63
|
SECONDARY outcome
Timeframe: Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
|
5.36 units on a scale
Standard Deviation 3.78
|
4.97 units on a scale
Standard Deviation 4.00
|
4.82 units on a scale
Standard Deviation 3.56
|
5.81 units on a scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=84 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=81 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=80 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Moderate worsening
|
1.2 percentage of participants
|
7.4 percentage of participants
|
3.8 percentage of participants
|
1.2 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Marked improvement
|
15.5 percentage of participants
|
19.8 percentage of participants
|
18.8 percentage of participants
|
26.7 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Moderate improvement
|
25.0 percentage of participants
|
24.7 percentage of participants
|
26.3 percentage of participants
|
19.8 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Slight improvement
|
23.8 percentage of participants
|
18.5 percentage of participants
|
21.3 percentage of participants
|
22.1 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
No change
|
28.6 percentage of participants
|
23.5 percentage of participants
|
27.5 percentage of participants
|
23.3 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Slight worsening
|
4.8 percentage of participants
|
6.2 percentage of participants
|
1.3 percentage of participants
|
4.7 percentage of participants
|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
Marked worsening
|
1.2 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=95 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=90 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=98 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Marked improvement
|
12.6 percentage of participants
|
12.2 percentage of participants
|
17.2 percentage of participants
|
16.3 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Moderate improvement
|
20.0 percentage of participants
|
18.9 percentage of participants
|
18.2 percentage of participants
|
27.6 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Slight improvement
|
21.1 percentage of participants
|
24.4 percentage of participants
|
31.3 percentage of participants
|
24.5 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
No change
|
41.1 percentage of participants
|
34.4 percentage of participants
|
32.3 percentage of participants
|
25.5 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Slight worsening
|
3.2 percentage of participants
|
2.2 percentage of participants
|
1.0 percentage of participants
|
2.0 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Moderate worsening
|
1.1 percentage of participants
|
7.8 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
Marked worsening
|
1.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=86 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=82 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=82 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
6.41 units on a scale
Standard Deviation 19.55
|
2.24 units on a scale
Standard Deviation 23.10
|
3.94 units on a scale
Standard Deviation 15.56
|
0.45 units on a scale
Standard Deviation 20.07
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=83 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=81 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=87 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
2.14 units on a scale
Standard Deviation 18.28
|
1.69 units on a scale
Standard Deviation 21.61
|
2.07 units on a scale
Standard Deviation 19.10
|
1.97 units on a scale
Standard Deviation 17.29
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=83 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
2.79 units on a scale
Standard Deviation 20.34
|
4.26 units on a scale
Standard Deviation 21.23
|
6.36 units on a scale
Standard Deviation 24.61
|
3.37 units on a scale
Standard Deviation 19.16
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=86 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
1.02 units on a scale
Standard Deviation 34.05
|
-2.61 units on a scale
Standard Deviation 28.08
|
0.73 units on a scale
Standard Deviation 25.94
|
6.07 units on a scale
Standard Deviation 30.90
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=87 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=87 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
5.49 units on a scale
Standard Deviation 16.25
|
3.39 units on a scale
Standard Deviation 19.70
|
3.66 units on a scale
Standard Deviation 20.10
|
2.33 units on a scale
Standard Deviation 19.14
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.
Outcome measures
| Measure |
Modified Intention-to-Treat (Placebo Treated Subjects)
n=86 Participants
Matching Placebo tablets administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant Good Clinical Practice (GCP) deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam (BRV) 5 mg/day, 2.5 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)
n=84 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)
n=85 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day.
The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy.
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score
|
8.1 units on a scale
Standard Deviation 22.0
|
6.9 units on a scale
Standard Deviation 23.5
|
7.3 units on a scale
Standard Deviation 21.1
|
5.5 units on a scale
Standard Deviation 20.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
BRV 5 mg/Day
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
BRV 20 mg/Day
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
BRV 50 mg/Day
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=98 participants at risk
Matching Placebo tablets administered twice a day
|
BRV 5 mg/Day
n=97 participants at risk
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
BRV 20 mg/Day
n=100 participants at risk
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
BRV 50 mg/Day
n=101 participants at risk
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
1.0%
1/97 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
1.0%
1/100 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration bronchial
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
1.0%
1/100 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Brain hypoxia
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
1.0%
1/100 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/100 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/98 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/97 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
1.0%
1/100 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=98 participants at risk
Matching Placebo tablets administered twice a day
|
BRV 5 mg/Day
n=97 participants at risk
Brivaracetam 5 mg/day, 2.5 mg administered twice a day
|
BRV 20 mg/Day
n=100 participants at risk
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
BRV 50 mg/Day
n=101 participants at risk
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.1%
3/98 • Number of events 3 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
4.1%
4/97 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
7.0%
7/100 • Number of events 8 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
5.9%
6/101 • Number of events 7 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
4.1%
4/97 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
4.0%
4/100 • Number of events 5 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
5.9%
6/101 • Number of events 6 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
2.0%
2/98 • Number of events 2 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
3.1%
3/97 • Number of events 3 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
13.0%
13/100 • Number of events 14 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
9.9%
10/101 • Number of events 12 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
1.0%
1/98 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
9.3%
9/97 • Number of events 10 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
6.0%
6/100 • Number of events 6 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
4.0%
4/101 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
4/98 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
5.2%
5/97 • Number of events 5 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
5.0%
5/100 • Number of events 5 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.00%
0/101 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
2/98 • Number of events 2 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
3.1%
3/97 • Number of events 3 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
6.0%
6/100 • Number of events 6 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
7.1%
7/98 • Number of events 7 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
14.4%
14/97 • Number of events 14 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
14.0%
14/100 • Number of events 15 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
16.8%
17/101 • Number of events 18 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
9.2%
9/98 • Number of events 13 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
12.4%
12/97 • Number of events 16 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
14.0%
14/100 • Number of events 15 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
15.8%
16/101 • Number of events 17 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
14.3%
14/98 • Number of events 21 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
11.3%
11/97 • Number of events 14 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
6.0%
6/100 • Number of events 8 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
12.9%
13/101 • Number of events 16 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/98 • Number of events 2 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
2.1%
2/97 • Number of events 2 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
3.0%
3/100 • Number of events 4 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
6.9%
7/101 • Number of events 7 • Adverse Events (AEs) were collected up to 23 weeks from Visit 1 (Week -8) to the Safety Visit (Week 15).
Adverse Events (AEs) refer to the Safety Population including all randomized subjects who received at least 1 dose of study medication.
|
Additional Information
Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60