Trial Outcomes & Findings for Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures (NCT NCT00490035)
NCT ID: NCT00490035
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 Secondarily Generalized Seizures.
COMPLETED
PHASE3
399 participants
From Baseline to 12-week Treatment Period
2022-07-21
Participant Flow
This study started to enroll subjects in September 2007 and concluded in February 2009.
Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Placebo
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
100
|
100
|
|
Overall Study
COMPLETED
|
92
|
93
|
88
|
94
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
12
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Overall Study
AE, non-serious non-fatal
|
3
|
4
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
|
Overall Study
Other reason
|
0
|
1
|
3
|
1
|
|
Overall Study
AE, serious fatal
|
1
|
0
|
0
|
0
|
|
Overall Study
Serious adverse event (SAE), non-fatal
|
0
|
0
|
1
|
0
|
|
Overall Study
AE of unknown type
|
0
|
0
|
2
|
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=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=100 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
Total Title
n=399 Participants
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
37.24 years
STANDARD_DEVIATION 13.05 • n=21 Participants
|
|
Age, Customized
<18 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Age, Customized
Between 18 and 65 years
|
96 participants
n=5 Participants
|
94 participants
n=7 Participants
|
97 participants
n=5 Participants
|
96 participants
n=4 Participants
|
383 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
171 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Finland
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From 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.
Partial (Type I) Seizures can be classified into one of the following three groups: Simple Partial Seizures, Complex Partial Seizures, Partial Seizures evolving to Secondarily Generalized Seizures.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
|
1.75 Seizure Frequency per Week
Interval 0.76 to 5.12
|
1.34 Seizure Frequency per Week
Interval 0.7 to 3.12
|
1.49 Seizure Frequency per Week
Interval 0.69 to 2.78
|
1.26 Seizure Frequency per Week
Interval 0.52 to 2.93
|
SECONDARY outcome
Timeframe: From 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.
Responders are those subjects with at least 50 % reduction from Baseline to Treatment Period in Partial Onset Seizure frequency per week. The Responder Rate for Partial Onset Seizures (Type I) is the proportion of subjects who have a \>= 50 % reduction in seizure frequency per week from Baseline.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period
Responders
|
20.0 Percentage of Participants
|
27.3 Percentage of Participants
|
27.3 Percentage of Participants
|
36.0 Percentage of Participants
|
|
Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period
Non-responders
|
80.0 Percentage of Participants
|
72.7 Percentage of Participants
|
72.7 Percentage of Participants
|
64.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From 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.
There are three types of Epilepsy: Partial Epilepsies (Type I), Generalized Epilepsies (Type II) and uncertain classification of Epilepsies (Type III).
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
|
1.75 Times per week
Interval 0.76 to 5.61
|
1.34 Times per week
Interval 0.7 to 3.12
|
1.49 Times per week
Interval 0.69 to 2.78
|
1.26 Times per week
Interval 0.52 to 2.93
|
SECONDARY outcome
Timeframe: From 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.
The percent change from Baseline was computed as: Weekly Seizure Frequency (Treatment) - Weekly Seizure Frequency (Baseline) / Weekly Seizure Frequency (Baseline) \* 100. Negative values indicate a reduction from Baseline with higher negative values showing higher reduction.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
|
-17.03 Percent change in seizures per week
Interval -40.27 to 17.59
|
-30.03 Percent change in seizures per week
Interval -55.99 to -2.11
|
-26.83 Percent change in seizures per week
Interval -60.05 to 6.32
|
-32.45 Percent change in seizures per week
Interval -72.51 to 0.04
|
SECONDARY outcome
Timeframe: From 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.
The categories are: * \<= 25 % * \- 25 % to \< 25 % * 25 % to \< 50 % * 50 % to \< 75 % * 75 % to \< 100 % * 100 %
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
<= 25 %
|
19.0 Percentage of Participants
|
10.1 Percentage of Participants
|
15.2 Percentage of Participants
|
10.0 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 %
|
41.0 Percentage of Participants
|
35.4 Percentage of Participants
|
33.3 Percentage of Participants
|
33.0 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 %
|
20.0 Percentage of Participants
|
27.3 Percentage of Participants
|
24.2 Percentage of Participants
|
21.0 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 %
|
12.0 Percentage of Participants
|
18.2 Percentage of Participants
|
17.2 Percentage of Participants
|
14.0 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 %
|
8.0 Percentage of Participants
|
7.1 Percentage of Participants
|
9.1 Percentage of Participants
|
18.0 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
|
2.0 Percentage of Participants
|
1.0 Percentage of Participants
|
4.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From 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.
Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
Seizure free
|
0 Percentage of Participants
|
2.0 Percentage of Participants
|
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
|
98.0 Percentage of Participants
|
99.0 Percentage of Participants
|
96.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From 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.
The time to first Type I Seizure during the 12-week Treatment Period was measured in days.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Time to First Type I Seizure During the 12-week Treatment Period
|
4 Days
Interval 3.0 to 5.0
|
6 Days
Interval 3.0 to 8.0
|
6 Days
Interval 4.0 to 10.0
|
4 Days
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: From 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.
The time to Fifth Type I Seizure during the 12-week Treatment Period was measured in days.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Time to Fifth Type I Seizure During the 12-week Treatment Period
|
19 Days
Interval 14.0 to 25.0
|
25 Days
Interval 20.0 to 34.0
|
24 Days
Interval 20.0 to 32.0
|
24 Days
Interval 18.0 to 34.0
|
SECONDARY outcome
Timeframe: From 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.
The time to tenth Type I Seizure during the 12-week Treatment Period was measured in days.
Outcome measures
| Measure |
Placebo
n=100 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Time to Tenth Type I Seizure During the 12-week Treatment Period
|
39 Days
Interval 24.0 to 50.0
|
49 Days
Interval 36.0 to 64.0
|
40 Days
Interval 33.0 to 49.0
|
46 Days
Interval 34.0 to 66.0
|
SECONDARY outcome
Timeframe: From 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 |
Placebo
n=37 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=36 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=40 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=39 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period.
|
45.9 percentage of participants
|
47.2 percentage of participants
|
62.5 percentage of participants
|
41.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
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 |
Placebo
n=86 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=91 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=94 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=80 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
2.29 units on a scale
Standard Deviation 14.03
|
4.50 units on a scale
Standard Deviation 12.71
|
3.09 units on a scale
Standard Deviation 14.43
|
1.78 units on a scale
Standard Deviation 13.95
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-To-Treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=96 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=86 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
8.25 units on a scale
Standard Deviation 22.01
|
6.23 units on a scale
Standard Deviation 17.97
|
5.34 units on a scale
Standard Deviation 23.81
|
8.04 units on a scale
Standard Deviation 26.26
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=96 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=85 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
-2.09 units on a scale
Standard Deviation 20.26
|
3.35 units on a scale
Standard Deviation 19.72
|
3.09 units on a scale
Standard Deviation 20.79
|
3.50 units on a scale
Standard Deviation 22.52
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation.
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Outcome measures
| Measure |
Placebo
n=86 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=91 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=95 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=83 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
|
-1.54 units on a scale
Standard Deviation 3.89
|
-0.59 units on a scale
Standard Deviation 3.89
|
-0.41 units on a scale
Standard Deviation 3.82
|
0.08 units on a scale
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit / Early Discontinuation Visit.
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression simultaneously. The HADS was developed as a self-administered scale that has been designed to assess the presence and severity of both anxiety and depression. 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. Negative values in Change from Baseline indicate a decrease of HADS from Baseline to Treatment Period.
Outcome measures
| Measure |
Placebo
n=86 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=91 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=95 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=83 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
|
-0.65 units on a scale
Standard Deviation 3.58
|
-0.10 units on a scale
Standard Deviation 3.67
|
0.26 units on a scale
Standard Deviation 3.84
|
-0.24 units on a scale
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
The 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 not mentally impaired had to complete it by answering the following question: "Overall, has there been a change in your seizures since the start of the study medication?"
Outcome measures
| Measure |
Placebo
n=81 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=90 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=90 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=85 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
|
4.93 units on a scale
Standard Deviation 1.39
|
5.17 units on a scale
Standard Deviation 1.27
|
5.04 units on a scale
Standard Deviation 1.29
|
5.47 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Last Visit or Early Discontinuation Visit in the 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 reference time point. The Investigator was to complete it by answering the following question: "Assess the Overall change in the severity of patient's illness, compared to start of study medication."
Outcome measures
| Measure |
Placebo
n=96 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=98 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
|
4.78 units on a scale
Standard Deviation 1.20
|
4.99 units on a scale
Standard Deviation 1.15
|
4.99 units on a scale
Standard Deviation 1.10
|
5.34 units on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=86 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=92 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=95 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=83 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
3.49 units on a scale
Standard Deviation 19.22
|
3.53 units on a scale
Standard Deviation 17.04
|
1.95 units on a scale
Standard Deviation 20.74
|
1.99 units on a scale
Standard Deviation 20.42
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=96 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=84 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
3.80 units on a scale
Standard Deviation 18.71
|
3.75 units on a scale
Standard Deviation 15.94
|
3.13 units on a scale
Standard Deviation 19.35
|
-2.45 units on a scale
Standard Deviation 18.55
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=96 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=85 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
1.80 units on a scale
Standard Deviation 19.16
|
5.36 units on a scale
Standard Deviation 20.69
|
1.02 units on a scale
Standard Deviation 19.95
|
0.69 units on a scale
Standard Deviation 16.66
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=92 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=96 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=86 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
0.92 units on a scale
Standard Deviation 28.93
|
3.64 units on a scale
Standard Deviation 29.24
|
-0.85 units on a scale
Standard Deviation 24.36
|
3.00 units on a scale
Standard Deviation 28.22
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=95 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=86 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
5.11 units on a scale
Standard Deviation 18.48
|
4.52 units on a scale
Standard Deviation 16.73
|
4.55 units on a scale
Standard Deviation 18.93
|
2.24 units on a scale
Standard Deviation 18.45
|
SECONDARY outcome
Timeframe: From Baseline to 12-week Treatment PeriodPopulation: Subjects in the Intention-to-treat (ITT) population with measurements at Baseline and Last Visit or Early Discontinuation Visit.
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 |
Placebo
n=88 Participants
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=93 Participants
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=95 Participants
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=84 Participants
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
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
|
6.6 units on a scale
Standard Deviation 16.3
|
6.9 units on a scale
Standard Deviation 20.1
|
9.7 units on a scale
Standard Deviation 19.8
|
4.9 units on a scale
Standard Deviation 18.1
|
Adverse Events
Placebo
Brivaracetam 20 mg/Day
Brivaracetam 50 mg/Day
Brivaracetam 100 mg/Day
Serious adverse events
| Measure |
Placebo
n=100 participants at risk
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 participants at risk
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 participants at risk
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 participants at risk
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Psychiatric disorders
Amnesia
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Cardiac disorders
Angina pectoris
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Convulsion
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Gastrointestinal disorders
Gastritis erosive
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Grand mal convulsion
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Psychiatric disorders
Psychotic Disorder
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Sepsis
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Status epilepticus
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
Other adverse events
| Measure |
Placebo
n=100 participants at risk
Matching Placebo tablets administered twice a day
|
Brivaracetam 20 mg/Day
n=99 participants at risk
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Brivaracetam 50 mg/Day
n=99 participants at risk
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Brivaracetam 100 mg/Day
n=100 participants at risk
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
5.1%
5/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
2.0%
2/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Dizziness
|
5.0%
5/100 • Number of events 11 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
5.1%
5/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
7.1%
7/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
General disorders
Fatigue
|
2.0%
2/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
3.0%
3/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
4.0%
4/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
8.0%
8/100 • Number of events 9 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Headache
|
10.0%
10/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
14.1%
14/99 • Number of events 19 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
18.2%
18/99 • Number of events 31 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
9.0%
9/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Psychiatric disorders
Irritability
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
5.1%
5/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Infections and infestations
Nasopharyngitis
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
8.1%
8/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
2.0%
2/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
4/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
0.00%
0/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
6.0%
6/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Nervous system disorders
Somnolence
|
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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
8.1%
8/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
6.1%
6/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
8.0%
8/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
3/100 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
1.0%
1/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
2.0%
2/99 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
8.0%
8/100 • Number of events 26 • 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 Set (SS) population wich contains the same set of subjects as the Intention-To-Treat (ITT) population.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60