Epilepsy
Conditions
Keywords
Epilepsy: partial onset seizures, brivaracetam
Brief summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
Interventions
OTHERPlacebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
DRUGBrivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male/female from 16 to 65 years * Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification * History of partial onset seizures * Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1 * Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
Exclusion criteria
* Seizure type IA non-motor as only seizure type * Seizures occurring only in clusters * Status epilepticus during the last 2 years before Visit 1 * History of cerebrovascular accident (CVA) * Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | During the 7-week Treatment Period | Calculated as 7-day partial onset seizure frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | Baseline, during the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | During the 7-week Treatment Period | Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period. |
| Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | During the 7-week Treatment Period | Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline. |
| Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | A responder was defined as a subject with a \>= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period. |
| Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | During the 7-week Treatment Period | Categories of percentage reductions in seizures from baseline were as following: \< -25 %; -25 % to \<25 %; 25 % to \<75 %; 75 % to \<100 %; 100 %. |
| Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | During the 7-week Treatment Period | A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period. |
| Number of Seizure-free Days Per 4 Weeks | Baseline, during the 7-week Treatment Period | A day was considered seizure-free, if no seizure was reported during 24 hours. |
| Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | During the 7-week Treatment Period | Number of days to first, fifth, and tenth seizure after baseline. |
Countries
Brazil, India, Mexico, United States
Participant flow
Recruitment details
The study started to enroll patients in November 2005 and concluded in June 2006.
Pre-assignment details
Participant Flow refers to the Intention-to-treat (ITT) Set. 210 subjects were initially randomized, 2 subjects discontinued due to Lost to Follow-Up before first study drug intake.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching Placebo tablets administered twice a day | 54 |
| Brivaracetam 5 mg/Day Brivaracetam 5 mg/day, 2.5 mg administered twice a day | 50 |
| Brivaracetam 20 mg/Day Brivaracetam 20 mg/day, 10 mg administered twice a day | 52 |
| Brivaracetam 50 mg/Day Brivaracetam 50 mg/day, 25 mg administered twice a day | 52 |
| Total Title | 208 |
| Total | 416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Brivaracetam 5 mg/Day | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Total Title |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 4 Participants | 1 Participants | 5 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 46 Participants | 50 Participants | 47 Participants | 194 Participants |
| Age, Continuous | 33.59 years STANDARD_DEVIATION 11.26 | 32.72 years STANDARD_DEVIATION 12.16 | 35.31 years STANDARD_DEVIATION 13.66 | 30.92 years STANDARD_DEVIATION 11.57 | 33.15 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 30 Participants | 20 Participants | 24 Participants | 24 Participants | 98 Participants |
| Sex: Female, Male Male | 24 Participants | 30 Participants | 28 Participants | 28 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 50 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 15 / 54 | 13 / 50 | 8 / 52 | 10 / 52 |
| serious Total, serious adverse events | 0 / 54 | 0 / 50 | 1 / 52 | 0 / 52 |
Outcome results
Primary
Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Calculated as 7-day partial onset seizure frequency.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | 1.81 Seizures per week |
| Brivaracetam 5 mg/Day | Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | 1.61 Seizures per week |
| Brivaracetam 20 mg/Day | Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | 1.55 Seizures per week |
| Brivaracetam 50 mg/Day | Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period | 0.92 Seizures per week |
Comparison: ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.p-value: =0.2495% CI: [-7.2, 24]ANCOVA
Comparison: ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.p-value: =0.06295% CI: [-0.8, 28.2]ANCOVA
Comparison: ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.p-value: =0.00495% CI: [7.6, 34.3]ANCOVA
Secondary
Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -0.40 seizures per week |
| Brivaracetam 5 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -0.66 seizures per week |
| Brivaracetam 20 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -0.80 seizures per week |
| Brivaracetam 50 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -0.92 seizures per week |
Secondary
Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | -0.37 seizures per week |
| Brivaracetam 5 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | -0.66 seizures per week |
| Brivaracetam 20 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | -0.84 seizures per week |
| Brivaracetam 50 mg/Day | Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period | -0.92 seizures per week |
Secondary
Number of Seizure-free Days Per 4 Weeks
A day was considered seizure-free, if no seizure was reported during 24 hours.
Time frame: Baseline, during the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Number of Seizure-free Days Per 4 Weeks | 22.66 Days/4 Weeks |
| Brivaracetam 5 mg/Day | Number of Seizure-free Days Per 4 Weeks | 22.86 Days/4 Weeks |
| Brivaracetam 20 mg/Day | Number of Seizure-free Days Per 4 Weeks | 22.84 Days/4 Weeks |
| Brivaracetam 50 mg/Day | Number of Seizure-free Days Per 4 Weeks | 24.65 Days/4 Weeks |
Secondary
Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: Baseline, during the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | -21.7 percentage of change |
| Brivaracetam 5 mg/Day | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | -29.91 percentage of change |
| Brivaracetam 20 mg/Day | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | -42.56 percentage of change |
| Brivaracetam 50 mg/Day | Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period | -53.04 percentage of change |
Secondary
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -24.35 percentage of change |
| Brivaracetam 5 mg/Day | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -29.91 percentage of change |
| Brivaracetam 20 mg/Day | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -41.57 percentage of change |
| Brivaracetam 50 mg/Day | Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period | -53.05 percentage of change |
Secondary
Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Completed the Period | 1.9 percentage of participants |
| Placebo | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Discontinued from the Period | 1.9 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Discontinued from the Period | 0 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Completed the Period | 8.0 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Completed the Period | 7.7 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Discontinued from the Period | 0 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Completed the Period | 5.8 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period | Discontinued from the Period | 0 percentage of participants |
Secondary
Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Categories of percentage reductions in seizures from baseline were as following: \< -25 %; -25 % to \<25 %; 25 % to \<75 %; 75 % to \<100 %; 100 %.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 75% to <100% | 1.9 percentage of participants |
| Placebo | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | -25% to <25% | 35.2 percentage of participants |
| Placebo | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 100% | 3.7 percentage of participants |
| Placebo | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 25% to <75% | 40.7 percentage of participants |
| Placebo | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | < -25% | 18.5 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 25% to <75% | 42.0 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 75% to <100% | 4.0 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 100% | 8.0 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | -25% to <25% | 38.0 percentage of participants |
| Brivaracetam 5 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | < -25% | 8.0 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 25% to <75% | 40.4 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | < -25% | 9.6 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | -25% to <25% | 30.8 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 75% to <100% | 11.5 percentage of participants |
| Brivaracetam 20 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 100% | 7.7 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 75% to <100% | 9.6 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | -25% to <25% | 13.5 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | < -25% | 13.5 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 25% to <75% | 55.8 percentage of participants |
| Brivaracetam 50 mg/Day | Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period | 100% | 7.7 percentage of participants |
Secondary
Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
A responder was defined as a subject with a \>= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | 16.7 percentage of participants |
| Brivaracetam 5 mg/Day | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | 32.0 percentage of participants |
| Brivaracetam 20 mg/Day | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | 44.2 percentage of participants |
| Brivaracetam 50 mg/Day | Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period | 55.8 percentage of participants |
Secondary
Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Baseline | 2.23 seizures per week |
| Placebo | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Treatment | 1.81 seizures per week |
| Brivaracetam 5 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Treatment | 1.61 seizures per week |
| Brivaracetam 5 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Baseline | 2.21 seizures per week |
| Brivaracetam 20 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Baseline | 2.50 seizures per week |
| Brivaracetam 20 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Treatment | 1.70 seizures per week |
| Brivaracetam 50 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Baseline | 1.99 seizures per week |
| Brivaracetam 50 mg/Day | Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period | Treatment | 0.92 seizures per week |
Secondary
Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Number of days to first, fifth, and tenth seizure after baseline.
Time frame: During the 7-week Treatment Period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to first seizure after baseline | 4.0 days |
| Placebo | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to tenth seizure after baseline | 32.0 days |
| Placebo | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to fifth seizure after baseline | 17.0 days |
| Brivaracetam 5 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to first seizure after baseline | 4.0 days |
| Brivaracetam 5 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to tenth seizure after baseline | 38.0 days |
| Brivaracetam 5 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to fifth seizure after baseline | 20.0 days |
| Brivaracetam 20 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to fifth seizure after baseline | 18.5 days |
| Brivaracetam 20 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to first seizure after baseline | 4.5 days |
| Brivaracetam 20 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to tenth seizure after baseline | 39.0 days |
| Brivaracetam 50 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to first seizure after baseline | 7.0 days |
| Brivaracetam 50 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to tenth seizure after baseline | 57.0 days |
| Brivaracetam 50 mg/Day | Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period | Number of days to fifth seizure after baseline | 32.5 days |