Trial Outcomes & Findings for A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy (NCT NCT00150709)

Results Overview

Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

223 participants

Primary outcome timeframe

During the Treatment Period (an average of 2 years), compared to Baseline

Results posted on

2024-02-09

Participant Flow

The study started to enroll patients in February 1998 and concluded in January 2006.

Participant Flow refers to the Intention-to-treat (ITT) Set.

Participant milestones

Participant milestones
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Overall Study STARTED	79	89	41	14
Overall Study COMPLETED	24	27	17	6
Overall Study NOT COMPLETED	55	62	24	8

Reasons for withdrawal

Reasons for withdrawal
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Overall Study Protocol Violation	7	8	3	1
Overall Study Adverse Event	8	2	2	3
Overall Study Lack of Efficacy	6	11	9	0
Overall Study Withdrawal by Subject	7	10	5	0
Overall Study Lost to Follow-up	3	2	0	0
Overall Study Sponsor decision	0	0	0	1
Overall Study Site/Investigator discontinued the study	5	5	2	0
Overall Study Decision of parent(s)	1	2	0	0
Overall Study Decision of parent(s) and investigator	3	0	0	0
Overall Study Loss/ incompleteness of efficacy	12	12	2	2
Overall Study Investigator decision	1	0	0	1
Overall Study Subject relocated	2	2	1	0
Overall Study Subject continues Keppra through prescriptions	0	4	0	0
Overall Study Convenience	0	1	0	0
Overall Study Subject entered new drug study	0	1	0	0
Overall Study Subject to undergo surgery for seizures	0	1	0	0
Overall Study Lack of ease of swallowing	0	1	0	0

Baseline Characteristics

A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).	Total Title n=223 Participants
Age, Categorical <=18 years	79 Participants n=5 Participants	89 Participants n=7 Participants	41 Participants n=5 Participants	14 Participants n=4 Participants	223 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	9.88 years STANDARD_DEVIATION 3.46 • n=5 Participants	10.61 years STANDARD_DEVIATION 3.24 • n=7 Participants	10.07 years STANDARD_DEVIATION 2.20 • n=5 Participants	1.62 years STANDARD_DEVIATION 1.16 • n=4 Participants	9.68 years STANDARD_DEVIATION 3.72 • n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	39 Participants n=7 Participants	16 Participants n=5 Participants	7 Participants n=4 Participants	105 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	50 Participants n=7 Participants	25 Participants n=5 Participants	7 Participants n=4 Participants	118 Participants n=21 Participants

PRIMARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects with valid data for Partial (Type I) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=87 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period	-66.4 percentage of change Interval -90.0 to -22.3	-47.8 percentage of change Interval -76.2 to -25.4	-66.4 percentage of change Interval -93.6 to -5.6	—

PRIMARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects with valid data for total (Type I, II, III) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=88 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period	-66.4 percentage of change Interval -90.0 to -25.2	-45.7 percentage of change Interval -73.6 to -17.4	-65.9 percentage of change Interval -93.1 to -5.6	—

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects with valid data for Partial Onset (Type I) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

Absolute change from Baseline of Partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=87 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period	-2.1 partial seizure frequency per week Interval -7.4 to -0.3	-1.6 partial seizure frequency per week Interval -6.6 to -0.6	-1.5 partial seizure frequency per week Interval -7.4 to 0.0	—

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects with valid data for total (Type I, II, III) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

Absolute change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate improvement from Baseline.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=88 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period	-2.1 partial seizure frequency per week Interval -7.4 to -0.6	-1.5 partial seizure frequency per week Interval -6.4 to -0.5	-1.1 partial seizure frequency per week Interval -7.3 to 0.0	—

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects who have a baseline greater than zero for partial onset (Type I) seizures and valid N157 seizure information are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

At least 50% responder rate in Partial Onset (Type I) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in Partial Onset (Type I) seizure frequency of at least 50%. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=77 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=86 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=37 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period	58.4 percentage of participants	47.7 percentage of participants	62.2 percentage of participants	—

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years), compared to Baseline

Population: Only subjects who have a baseline greater than zero for partial onset (Type I) seizures and valid N157 seizure information are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.

At least 50% responder rate in total (Type I, II, III) Seizure Frequency per Week over the Treatment Period is defined as the percentage of subjects with a reduction from baseline in total (Type I, II, III) seizure frequency of at least 50%. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=77 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=88 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=37 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period	58.4 percentage of participants	46.6 percentage of participants	62.2 percentage of participants	—

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years)

A day was considered seizure-free if no seizures were reported for 24 hours.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period	74 Participants	73 Participants	40 Participants	10 Participants

SECONDARY outcome

Timeframe: Day 0 (beginning day of the maintenance phase)

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 0)	74.0 percentage of participants	64.0 percentage of participants	75.0 percentage of participants	38.5 percentage of participants

SECONDARY outcome

Timeframe: Day 1 - <= 2 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (Day 1 - <= 2 Months)	16.4 percentage of participants	15.1 percentage of participants	27.5 percentage of participants	23.1 percentage of participants

SECONDARY outcome

Timeframe: > 2 months - <= 4 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 2 Months - <= 4 Months)	12.3 percentage of participants	12.8 percentage of participants	17.5 percentage of participants	23.1 percentage of participants

SECONDARY outcome

Timeframe: > 4 months - <= 6 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 4 Months - <= 6 Months)	11.0 percentage of participants	9.3 percentage of participants	15.0 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 6 months - <= 8 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 6 Months - <= 8 Months)	8.2 percentage of participants	4.7 percentage of participants	12.5 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 8 months - <= 10 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 8 Months - <= 10 Months)	5.5 percentage of participants	3.5 percentage of participants	10.0 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 10 months - <= 12 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 10 Months - <= 12 Months)	1.4 percentage of participants	3.5 percentage of participants	7.5 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 12 months - <= 14 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 12 Months - <= 14 Months)	1.4 percentage of participants	2.3 percentage of participants	5.0 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 14 months - <= 16 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 14 Months - <= 16 Months)	1.4 percentage of participants	2.3 percentage of participants	5.0 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 16 months - <= 18 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 16 Months - <= 18 Months)	1.4 percentage of participants	2.3 percentage of participants	2.5 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: > 18 months - <= 20 months of the Maintenance Phase

A time interval was considered seizure-free if no seizures were reported in that time interval. The Treatment Period consisted of a 6-week Titration Phase and a Maintenance Phase lasting until market approval or completion of development of levetiracetam for the pediatric indication.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Cumulative Percentage of Subjects Who Are Continuously Seizure Free by Time Interval (> 18 Months - <= 20 Months)	1.4 percentage of participants	2.3 percentage of participants	2.5 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: During the Treatment Period (an average of 2 years)

Number of following seizure types were assessed: Total seizures (Type I, II, III), Total Type I seizures, Total Type II seizures, Total Type III seizures

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=79 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Number of Seizures by Type During the Treatment Period Total seizures (Type I, II, III)	42132 seizures	70121 seizures	24232 seizures	19914 seizures
Number of Seizures by Type During the Treatment Period Total Type I seizures	39147 seizures	57464 seizures	24089 seizures	13675 seizures
Number of Seizures by Type During the Treatment Period Total Type II seizures	2142 seizures	12656 seizures	142 seizures	6239 seizures
Number of Seizures by Type During the Treatment Period Total Type III seizures	843 seizures	1 seizures	1 seizures	0 seizures

SECONDARY outcome

Timeframe: Visit 1 (Screening Visit (Week 0))

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Marked improvement	7.7 percentage of participants	11.2 percentage of participants	29.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Moderate improvement	21.8 percentage of participants	18.0 percentage of participants	12.2 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Slight improvement	12.8 percentage of participants	24.7 percentage of participants	19.5 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 No change	47.4 percentage of participants	40.4 percentage of participants	26.8 percentage of participants	100.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Slight worsening	5.1 percentage of participants	5.6 percentage of participants	12.2 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Moderate worsening	3.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Not done	1.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Titration Visit 1 (Week 2)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 1 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The Global Evaluation Scale (GES) is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=74 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=82 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Marked improvement	14.9 percentage of participants	6.1 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Moderate improvement	14.9 percentage of participants	14.6 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Slight improvement	32.4 percentage of participants	18.3 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 No change	33.8 percentage of participants	47.6 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Slight worsening	4.1 percentage of participants	9.8 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Moderate worsening	0.0 percentage of participants	2.4 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Not done	0.0 percentage of participants	1.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: Titration Visit 2 (Week 4)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 2 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=75 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=84 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Marked improvement	10.7 percentage of participants	13.1 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Moderate improvement	20.0 percentage of participants	8.3 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Slight improvement	20.0 percentage of participants	15.5 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 No change	37.3 percentage of participants	46.4 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Slight worsening	9.3 percentage of participants	11.9 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Moderate worsening	2.7 percentage of participants	2.4 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Not done	0.0 percentage of participants	2.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Titration Visit 3 (Week 6)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 3 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=67 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=73 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Marked improvement	10.4 percentage of participants	4.1 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Moderate improvement	14.9 percentage of participants	8.2 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Slight improvement	17.9 percentage of participants	21.9 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 No change	41.8 percentage of participants	47.9 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Slight worsening	7.5 percentage of participants	9.6 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Moderate worsening	4.5 percentage of participants	4.1 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Marked worsening	0.0 percentage of participants	1.4 percentage of participants	—	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Not done	3.0 percentage of participants	2.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Visit 2 (Month 2)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=73 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=84 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=39 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=12 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Marked worsening	1.4 percentage of participants	2.4 percentage of participants	0.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 No change	34.2 percentage of participants	46.4 percentage of participants	28.2 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Slight worsening	15.1 percentage of participants	8.3 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Moderate worsening	2.7 percentage of participants	2.4 percentage of participants	2.6 percentage of participants	8.3 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Not done	1.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Marked improvement	4.1 percentage of participants	8.3 percentage of participants	20.5 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Moderate improvement	15.1 percentage of participants	14.3 percentage of participants	20.5 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Slight improvement	26.0 percentage of participants	17.9 percentage of participants	25.6 percentage of participants	25.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 3 (Month 4)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=68 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=77 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=38 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=10 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Marked improvement	4.4 percentage of participants	6.5 percentage of participants	15.8 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Moderate improvement	7.4 percentage of participants	3.9 percentage of participants	15.8 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Slight improvement	20.6 percentage of participants	14.3 percentage of participants	26.3 percentage of participants	30.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 No change	41.2 percentage of participants	50.6 percentage of participants	34.2 percentage of participants	40.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Slight worsening	20.6 percentage of participants	20.8 percentage of participants	7.9 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Moderate worsening	5.9 percentage of participants	3.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 4 (Month 6)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=63 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=75 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=35 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=10 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Marked improvement	4.8 percentage of participants	4.0 percentage of participants	14.3 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Moderate improvement	6.3 percentage of participants	10.7 percentage of participants	17.1 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Slight improvement	23.8 percentage of participants	28.0 percentage of participants	8.6 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 No change	42.9 percentage of participants	34.7 percentage of participants	42.9 percentage of participants	60.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Slight worsening	12.7 percentage of participants	17.3 percentage of participants	14.3 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Moderate worsening	7.9 percentage of participants	4.0 percentage of participants	2.9 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Not done	1.6 percentage of participants	1.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 5 (Month 9)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=59 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=65 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=32 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=9 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Marked improvement	3.4 percentage of participants	6.2 percentage of participants	3.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Moderate improvement	13.6 percentage of participants	6.2 percentage of participants	15.6 percentage of participants	22.2 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Slight improvement	25.4 percentage of participants	18.5 percentage of participants	9.4 percentage of participants	22.2 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 No change	35.6 percentage of participants	46.2 percentage of participants	53.1 percentage of participants	44.4 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Slight worsening	18.6 percentage of participants	16.9 percentage of participants	12.5 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Moderate worsening	3.4 percentage of participants	4.6 percentage of participants	6.3 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Marked worsening	0.0 percentage of participants	1.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 6 (Month 12)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=54 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=61 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=9 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Marked improvement	5.6 percentage of participants	1.6 percentage of participants	10.7 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Moderate improvement	16.7 percentage of participants	13.1 percentage of participants	14.3 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Slight improvement	22.2 percentage of participants	19.7 percentage of participants	17.9 percentage of participants	22.2 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 No change	29.6 percentage of participants	41.0 percentage of participants	39.3 percentage of participants	55.6 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Slight worsening	20.4 percentage of participants	18.0 percentage of participants	14.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Moderate worsening	3.7 percentage of participants	6.6 percentage of participants	3.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Marked worsening	1.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 7 (Month 15)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=47 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=52 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=8 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Marked improvement	12.8 percentage of participants	9.6 percentage of participants	3.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Moderate improvement	4.3 percentage of participants	13.5 percentage of participants	7.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Slight improvement	23.4 percentage of participants	11.5 percentage of participants	14.3 percentage of participants	37.5 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 No change	42.6 percentage of participants	40.4 percentage of participants	39.3 percentage of participants	37.5 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Slight worsening	12.8 percentage of participants	21.2 percentage of participants	25.0 percentage of participants	12.5 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Moderate worsening	2.1 percentage of participants	1.9 percentage of participants	10.7 percentage of participants	12.5 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Marked worsening	2.1 percentage of participants	1.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 8 (Month 18)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=40 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=51 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=6 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Marked improvement	10.0 percentage of participants	3.9 percentage of participants	3.6 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Moderate improvement	5.0 percentage of participants	11.8 percentage of participants	17.9 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Slight improvement	20.0 percentage of participants	23.5 percentage of participants	14.3 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 No change	37.5 percentage of participants	39.2 percentage of participants	42.9 percentage of participants	66.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Slight worsening	25.0 percentage of participants	17.6 percentage of participants	14.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Moderate worsening	2.5 percentage of participants	3.9 percentage of participants	7.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9 (Month 21)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=39 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=49 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=27 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=5 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Marked improvement	5.1 percentage of participants	8.2 percentage of participants	14.8 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Moderate improvement	7.7 percentage of participants	14.3 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Slight improvement	12.8 percentage of participants	22.4 percentage of participants	22.2 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 No change	48.7 percentage of participants	34.7 percentage of participants	33.3 percentage of participants	80.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Slight worsening	23.1 percentage of participants	18.4 percentage of participants	7.4 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Moderate worsening	2.6 percentage of participants	0.0 percentage of participants	7.4 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Marked worsening	0.0 percentage of participants	2.0 percentage of participants	3.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 10 (Month 24)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=35 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=47 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=25 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=6 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Marked improvement	5.7 percentage of participants	6.4 percentage of participants	4.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Moderate improvement	8.6 percentage of participants	12.8 percentage of participants	8.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Slight improvement	22.9 percentage of participants	17.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 No change	45.7 percentage of participants	51.1 percentage of participants	48.0 percentage of participants	66.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Slight worsening	11.4 percentage of participants	12.8 percentage of participants	20.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Moderate worsening	5.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 11 (Month 27)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=32 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=44 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=22 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=5 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Moderate worsening	0.0 percentage of participants	4.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Marked worsening	0.0 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Not done	3.1 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Marked improvement	9.4 percentage of participants	2.3 percentage of participants	4.5 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Moderate improvement	9.4 percentage of participants	6.8 percentage of participants	22.7 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Slight improvement	21.9 percentage of participants	20.5 percentage of participants	13.6 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Slight worsening	6.3 percentage of participants	15.9 percentage of participants	4.5 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 No change	50.0 percentage of participants	45.5 percentage of participants	54.5 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 12 (Month 30)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=30 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=39 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=18 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Marked improvement	6.7 percentage of participants	5.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Moderate improvement	6.7 percentage of participants	15.4 percentage of participants	5.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Slight improvement	33.3 percentage of participants	25.6 percentage of participants	11.1 percentage of participants	25.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 No change	33.3 percentage of participants	43.6 percentage of participants	61.1 percentage of participants	75.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Slight worsening	16.7 percentage of participants	7.7 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Moderate worsening	0.0 percentage of participants	2.6 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Marked worsening	3.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 13 (Month 33)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=26 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=30 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=9 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Marked improvement	3.8 percentage of participants	3.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Moderate improvement	7.7 percentage of participants	6.7 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Slight improvement	34.6 percentage of participants	23.3 percentage of participants	22.2 percentage of participants	50.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 No change	38.5 percentage of participants	46.7 percentage of participants	55.6 percentage of participants	50.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Slight worsening	15.4 percentage of participants	16.7 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Moderate worsening	0.0 percentage of participants	3.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 14 (Month 36)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=15 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=24 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=9 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Marked improvement	13.3 percentage of participants	4.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Slight improvement	33.3 percentage of participants	16.7 percentage of participants	11.1 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 No change	40.0 percentage of participants	45.8 percentage of participants	66.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Slight worsening	13.3 percentage of participants	25.0 percentage of participants	11.1 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Moderate worsening	0.0 percentage of participants	8.3 percentage of participants	11.1 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 15 (Month 39)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=15 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=21 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=7 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Marked improvement	6.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Slight improvement	26.7 percentage of participants	28.6 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 No change	46.7 percentage of participants	61.9 percentage of participants	57.1 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Slight worsening	6.7 percentage of participants	9.5 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Moderate worsening	13.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 16 (Month 42)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=14 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=18 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=7 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Marked improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Moderate improvement	0.0 percentage of participants	5.6 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Slight improvement	35.7 percentage of participants	11.1 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 No change	42.9 percentage of participants	61.1 percentage of participants	85.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Slight worsening	14.3 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Moderate worsening	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Marked worsening	0.0 percentage of participants	5.6 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 17 (Month 45)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=17 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=6 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Marked improvement	7.7 percentage of participants	11.8 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Slight improvement	38.5 percentage of participants	17.6 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 No change	53.8 percentage of participants	47.1 percentage of participants	83.3 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Slight worsening	0.0 percentage of participants	23.5 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 18 (Month 48)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=6 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Marked improvement	7.7 percentage of participants	15.4 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Slight improvement	15.4 percentage of participants	30.8 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 No change	46.2 percentage of participants	38.5 percentage of participants	50.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Slight worsening	30.8 percentage of participants	15.4 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 19 (Month 51)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=11 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Marked improvement	9.1 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Moderate improvement	0.0 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Slight improvement	18.2 percentage of participants	15.4 percentage of participants	40.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 No change	54.5 percentage of participants	46.2 percentage of participants	60.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Slight worsening	18.2 percentage of participants	23.1 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 20 (Month 54)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=11 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=12 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Marked improvement	0.0 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Moderate improvement	9.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Slight improvement	18.2 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 No change	63.6 percentage of participants	58.3 percentage of participants	100.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Slight worsening	9.1 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Moderate worsening	0.0 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 21 (Month 57)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=9 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=8 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Marked improvement	22.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Moderate improvement	0.0 percentage of participants	12.5 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Slight improvement	22.2 percentage of participants	12.5 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 No change	55.6 percentage of participants	62.5 percentage of participants	80.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Slight worsening	0.0 percentage of participants	12.5 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 22 (Month 60)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=3 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=4 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Marked improvement	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Slight improvement	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 No change	33.3 percentage of participants	75.0 percentage of participants	60.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Slight worsening	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Moderate worsening	0.0 percentage of participants	25.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 23 (Month 63)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=2 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=1 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Marked improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Slight improvement	50.0 percentage of participants	100.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 No change	50.0 percentage of participants	0.0 percentage of participants	40.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Slight worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 24 (Month 66)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=1 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Marked improvement	0.0 percentage of participants	—	20.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Moderate improvement	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Slight improvement	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 No change	100.0 percentage of participants	—	80.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Slight worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Moderate worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Marked worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Not done	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 25 (Month 69)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 26 (Month 72)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Moderate improvement	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 27 (Month 75)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Moderate improvement	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 28 (Month 78)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 29 (Month 81)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Slight worsening	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 30 (Month 84)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 31 (Month 87)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=2 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Withdrawal visit (up to Month 90)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=17 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=14 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Marked improvement	5.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Moderate improvement	5.9 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Slight improvement	5.9 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	25.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit No change	41.2 percentage of participants	50.0 percentage of participants	0.0 percentage of participants	75.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Slight worsening	11.8 percentage of participants	35.7 percentage of participants	60.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Moderate worsening	23.5 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Marked worsening	5.9 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Final visit (up to Month 90)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the investigator applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=69 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=81 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=13 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Marked improvement	4.3 percentage of participants	3.7 percentage of participants	2.4 percentage of participants	7.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Moderate improvement	11.6 percentage of participants	6.2 percentage of participants	17.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Slight improvement	23.2 percentage of participants	9.9 percentage of participants	14.6 percentage of participants	7.7 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit No change	36.2 percentage of participants	61.7 percentage of participants	51.2 percentage of participants	69.2 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Slight worsening	17.4 percentage of participants	9.9 percentage of participants	4.9 percentage of participants	15.4 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Moderate worsening	4.3 percentage of participants	6.2 percentage of participants	9.8 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Marked worsening	1.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Investigator's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Not done	1.4 percentage of participants	2.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 1 (Screening Visit (Week 0))

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit). The reference time point for Visit 1 is in the respective feeder study of the participant.

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=78 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=89 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=14 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Marked improvement	12.8 percentage of participants	18.0 percentage of participants	29.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Moderate improvement	16.7 percentage of participants	15.7 percentage of participants	14.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Slight improvement	17.9 percentage of participants	19.1 percentage of participants	14.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 No change	41.0 percentage of participants	38.2 percentage of participants	24.4 percentage of participants	92.9 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Slight worsening	7.7 percentage of participants	7.9 percentage of participants	17.1 percentage of participants	7.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Moderate worsening	3.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 1 Not done	0.0 percentage of participants	1.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Titration Visit 1 (Week 2)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 1 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=74 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=82 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Marked improvement	17.6 percentage of participants	11.0 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Moderate improvement	18.9 percentage of participants	11.0 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Slight improvement	32.4 percentage of participants	17.1 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 No change	25.7 percentage of participants	48.8 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Slight worsening	4.1 percentage of participants	8.5 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Moderate worsening	0.0 percentage of participants	1.2 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 1 Not done	1.4 percentage of participants	2.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Titration Visit 2 (Week 4)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 2 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=75 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=84 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Not done	1.3 percentage of participants	1.2 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Slight worsening	6.7 percentage of participants	15.5 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Moderate worsening	2.7 percentage of participants	1.2 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 No change	36.0 percentage of participants	39.3 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Marked improvement	17.3 percentage of participants	16.7 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Moderate improvement	16.0 percentage of participants	10.7 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 2 Slight improvement	20.0 percentage of participants	15.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Titration Visit 3 (Week 6)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis. The data for 'N01010+N151 LEV/LEV' and 'N01052 LEV/LEV' arms was not available as the Titration Visit 3 was required only for subjects previously enrolled in N159.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=67 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=73 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Marked improvement	10.4 percentage of participants	4.1 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Moderate improvement	9.0 percentage of participants	12.3 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Slight improvement	20.9 percentage of participants	27.4 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 No change	43.3 percentage of participants	41.1 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Slight worsening	9.0 percentage of participants	8.2 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Moderate worsening	3.0 percentage of participants	4.1 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Marked worsening	1.5 percentage of participants	1.4 percentage of participants	—	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Titration Visit 3 Not done	3.0 percentage of participants	1.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Visit 2 (Month 2)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=73 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=84 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=39 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=12 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Marked improvement	6.8 percentage of participants	13.1 percentage of participants	25.6 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Moderate improvement	17.8 percentage of participants	11.9 percentage of participants	15.4 percentage of participants	8.3 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Slight improvement	21.9 percentage of participants	16.7 percentage of participants	20.5 percentage of participants	41.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 No change	30.1 percentage of participants	45.2 percentage of participants	17.9 percentage of participants	8.3 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Slight worsening	17.8 percentage of participants	4.8 percentage of participants	17.9 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Moderate worsening	2.7 percentage of participants	4.8 percentage of participants	2.6 percentage of participants	8.3 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Marked worsening	2.7 percentage of participants	1.2 percentage of participants	0.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 2 Not done	0.0 percentage of participants	2.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 3 (Month 4)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=68 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=77 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=38 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=10 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Marked improvement	8.8 percentage of participants	6.5 percentage of participants	18.4 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Moderate improvement	5.9 percentage of participants	6.5 percentage of participants	15.8 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Slight improvement	16.2 percentage of participants	13.0 percentage of participants	18.4 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 No change	38.2 percentage of participants	48.1 percentage of participants	36.8 percentage of participants	30.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Slight worsening	19.1 percentage of participants	22.1 percentage of participants	7.9 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Moderate worsening	10.3 percentage of participants	3.9 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Marked worsening	1.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 3 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 4 (Month 6)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=63 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=75 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=35 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=10 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Slight improvement	22.2 percentage of participants	29.3 percentage of participants	5.7 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 No change	39.7 percentage of participants	33.3 percentage of participants	37.1 percentage of participants	50.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Slight worsening	19.0 percentage of participants	17.3 percentage of participants	17.1 percentage of participants	10.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Moderate worsening	4.8 percentage of participants	5.3 percentage of participants	5.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Marked worsening	1.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Marked improvement	4.8 percentage of participants	8.0 percentage of participants	20.0 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 4 Moderate improvement	7.9 percentage of participants	6.7 percentage of participants	14.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 5 (Month 9)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=59 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=65 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=32 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=9 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Marked improvement	6.8 percentage of participants	10.8 percentage of participants	9.4 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Moderate improvement	10.2 percentage of participants	6.2 percentage of participants	9.4 percentage of participants	33.3 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Slight improvement	25.4 percentage of participants	12.3 percentage of participants	9.4 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 No change	33.9 percentage of participants	46.2 percentage of participants	50.0 percentage of participants	33.3 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Slight worsening	20.3 percentage of participants	15.4 percentage of participants	9.4 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Moderate worsening	0.0 percentage of participants	6.2 percentage of participants	12.5 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 5 Marked worsening	3.4 percentage of participants	3.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 6 (Month 12)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=54 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=61 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=9 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Marked improvement	7.4 percentage of participants	8.2 percentage of participants	14.3 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Moderate improvement	9.3 percentage of participants	13.1 percentage of participants	14.3 percentage of participants	11.1 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Slight improvement	25.9 percentage of participants	23.0 percentage of participants	14.3 percentage of participants	22.2 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 No change	33.3 percentage of participants	34.4 percentage of participants	39.3 percentage of participants	55.6 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Slight worsening	18.5 percentage of participants	11.5 percentage of participants	14.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Moderate worsening	3.7 percentage of participants	8.2 percentage of participants	3.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Marked worsening	1.9 percentage of participants	1.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 6 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 7 (Month 15)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=47 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=52 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=8 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Marked improvement	10.6 percentage of participants	19.2 percentage of participants	7.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Moderate improvement	10.6 percentage of participants	9.6 percentage of participants	7.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Moderate worsening	4.3 percentage of participants	3.8 percentage of participants	3.6 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Slight improvement	23.4 percentage of participants	7.7 percentage of participants	10.7 percentage of participants	37.5 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 No change	29.8 percentage of participants	40.4 percentage of participants	42.9 percentage of participants	37.5 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Slight worsening	19.1 percentage of participants	15.4 percentage of participants	25.0 percentage of participants	12.5 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Marked worsening	2.1 percentage of participants	1.9 percentage of participants	3.6 percentage of participants	12.5 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 7 Not done	0.0 percentage of participants	1.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 8 (Month 18)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=40 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=51 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=28 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=6 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Marked improvement	5.0 percentage of participants	15.7 percentage of participants	7.1 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Moderate improvement	7.5 percentage of participants	9.8 percentage of participants	14.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Slight improvement	17.5 percentage of participants	17.6 percentage of participants	14.3 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 No change	45.0 percentage of participants	35.3 percentage of participants	42.9 percentage of participants	66.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Slight worsening	22.5 percentage of participants	15.7 percentage of participants	10.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Moderate worsening	2.5 percentage of participants	3.9 percentage of participants	10.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Marked worsening	0.0 percentage of participants	2.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 8 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9 (Month 21)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=39 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=49 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=27 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=5 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Slight improvement	10.3 percentage of participants	14.3 percentage of participants	22.2 percentage of participants	40.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Marked improvement	10.3 percentage of participants	12.2 percentage of participants	18.5 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Moderate improvement	7.7 percentage of participants	10.2 percentage of participants	7.4 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 No change	56.4 percentage of participants	53.1 percentage of participants	33.3 percentage of participants	40.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Slight worsening	10.3 percentage of participants	6.1 percentage of participants	3.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Moderate worsening	5.1 percentage of participants	2.0 percentage of participants	11.1 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Marked worsening	0.0 percentage of participants	2.0 percentage of participants	3.7 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 9 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 10 (Month 24)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=35 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=47 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=25 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=6 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Marked improvement	8.6 percentage of participants	8.5 percentage of participants	12.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Moderate improvement	5.7 percentage of participants	8.5 percentage of participants	4.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Slight improvement	22.9 percentage of participants	21.3 percentage of participants	20.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 No change	42.9 percentage of participants	48.9 percentage of participants	40.0 percentage of participants	66.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Slight worsening	11.4 percentage of participants	10.6 percentage of participants	20.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Moderate worsening	5.7 percentage of participants	2.1 percentage of participants	0.0 percentage of participants	16.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Marked worsening	2.9 percentage of participants	0.0 percentage of participants	4.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 10 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 11 (Month 27)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=32 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=44 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=22 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=5 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Marked improvement	9.4 percentage of participants	9.1 percentage of participants	9.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Moderate improvement	9.4 percentage of participants	4.5 percentage of participants	22.7 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Slight improvement	18.8 percentage of participants	18.2 percentage of participants	9.1 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 No change	53.1 percentage of participants	45.5 percentage of participants	54.5 percentage of participants	40.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Slight worsening	6.3 percentage of participants	11.4 percentage of participants	4.5 percentage of participants	20.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Moderate worsening	0.0 percentage of participants	6.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Marked worsening	0.0 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 11 Not done	3.1 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 12 (Month 30)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=30 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=39 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=18 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Not done	0.0 percentage of participants	2.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Moderate worsening	3.3 percentage of participants	2.6 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Marked improvement	6.7 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Moderate improvement	13.3 percentage of participants	12.8 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Slight improvement	26.7 percentage of participants	20.5 percentage of participants	5.6 percentage of participants	25.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 No change	33.3 percentage of participants	48.7 percentage of participants	55.6 percentage of participants	75.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 12 Slight worsening	16.7 percentage of participants	5.1 percentage of participants	16.7 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 13 (Month 33)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=26 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=30 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=9 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Marked improvement	7.7 percentage of participants	3.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Moderate improvement	23.1 percentage of participants	6.7 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Slight improvement	15.4 percentage of participants	23.3 percentage of participants	22.2 percentage of participants	25.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 No change	38.5 percentage of participants	46.7 percentage of participants	55.6 percentage of participants	75.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Slight worsening	15.4 percentage of participants	16.7 percentage of participants	11.1 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Moderate worsening	0.0 percentage of participants	3.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 13 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 14 (Month 36)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=15 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=24 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=9 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Marked improvement	20.0 percentage of participants	4.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Moderate improvement	0.0 percentage of participants	4.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Slight improvement	26.7 percentage of participants	12.5 percentage of participants	11.1 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 No change	40.0 percentage of participants	50.0 percentage of participants	66.7 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Slight worsening	13.3 percentage of participants	20.8 percentage of participants	22.2 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Moderate worsening	0.0 percentage of participants	4.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Marked worsening	0.0 percentage of participants	4.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 14 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 15 (Month 39)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=15 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=21 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=7 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Marked improvement	6.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Moderate improvement	6.7 percentage of participants	0.0 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Slight improvement	40.0 percentage of participants	28.6 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 No change	40.0 percentage of participants	52.4 percentage of participants	57.1 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Slight worsening	6.7 percentage of participants	9.5 percentage of participants	14.3 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Moderate worsening	0.0 percentage of participants	4.8 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 15 Not done	0.0 percentage of participants	4.8 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 16 (Month 42)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=14 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=18 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=7 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Marked improvement	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Moderate improvement	21.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Slight improvement	14.3 percentage of participants	16.7 percentage of participants	28.6 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 No change	35.7 percentage of participants	55.6 percentage of participants	71.4 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Slight worsening	14.3 percentage of participants	22.2 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Moderate worsening	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Marked worsening	0.0 percentage of participants	5.6 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 16 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 17 (Month 45)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=17 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=6 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Marked improvement	15.4 percentage of participants	11.8 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Slight improvement	38.5 percentage of participants	23.5 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 No change	46.2 percentage of participants	41.2 percentage of participants	83.3 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Slight worsening	0.0 percentage of participants	17.6 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Moderate worsening	0.0 percentage of participants	5.9 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 17 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 18 (Month 48)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=6 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Moderate improvement	0.0 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Slight improvement	23.1 percentage of participants	23.1 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Marked improvement	0.0 percentage of participants	15.4 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 No change	38.5 percentage of participants	38.5 percentage of participants	50.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Slight worsening	38.5 percentage of participants	15.4 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	16.7 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 18 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 19 (Month 51)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=11 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=13 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Marked improvement	9.1 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Moderate improvement	0.0 percentage of participants	7.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Slight improvement	27.3 percentage of participants	23.1 percentage of participants	40.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 No change	45.5 percentage of participants	38.5 percentage of participants	60.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Slight worsening	18.2 percentage of participants	23.1 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 19 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 20 (Month 54)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=11 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=12 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Marked improvement	9.1 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Moderate improvement	9.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Slight improvement	9.1 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 No change	63.6 percentage of participants	66.7 percentage of participants	100.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Slight worsening	9.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Moderate worsening	0.0 percentage of participants	8.3 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 20 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 21 (Month 57)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=9 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=8 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Marked improvement	22.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Slight improvement	22.2 percentage of participants	37.5 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 No change	55.6 percentage of participants	50.0 percentage of participants	60.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Slight worsening	0.0 percentage of participants	12.5 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 21 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 22 (Month 60)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=3 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=4 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Marked improvement	33.3 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Slight improvement	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 No change	33.3 percentage of participants	75.0 percentage of participants	60.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Slight worsening	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Moderate worsening	0.0 percentage of participants	25.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 22 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 23 (Month 63)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=2 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=1 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Marked improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Moderate improvement	50.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Slight improvement	0.0 percentage of participants	100.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 No change	50.0 percentage of participants	0.0 percentage of participants	40.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Slight worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Moderate worsening	0.0 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Marked worsening	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 23 Not done	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 24 (Month 66)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=1 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Marked improvement	0.0 percentage of participants	—	20.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Moderate improvement	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Slight improvement	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 No change	100.0 percentage of participants	—	80.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Slight worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Moderate worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Marked worsening	0.0 percentage of participants	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 24 Not done	0.0 percentage of participants	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 25 (Month 69)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 25 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 26 (Month 72)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Moderate improvement	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 26 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 27 (Month 75)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Moderate improvement	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 27 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 28 (Month 78)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 28 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 29 (Month 81)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 No change	—	—	75.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Slight worsening	—	—	25.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 29 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 30 (Month 84)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=4 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 30 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Visit 31 (Month 87)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=2 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Marked improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Moderate improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Slight improvement	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 No change	—	—	100.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Slight worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Moderate worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Marked worsening	—	—	0.0 percentage of participants	—
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Visit 31 Not done	—	—	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Withdrawal visit (up to Month 90)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=17 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=14 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=5 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=4 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Marked improvement	5.9 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Moderate improvement	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Slight improvement	5.9 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	25.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit No change	41.2 percentage of participants	42.9 percentage of participants	40.0 percentage of participants	75.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Slight worsening	29.4 percentage of participants	21.4 percentage of participants	20.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Moderate worsening	17.6 percentage of participants	14.3 percentage of participants	20.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Marked worsening	0.0 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Withdrawal Visit Not done	0.0 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Final visit (up to Month 90)

Population: Only subjects with available data for disease evolution compared to the previous visit are included in the analysis.

Disease evolution compared to the last visit was evaluated by the parent/legal guardian applying following categories: Marked improvement, moderate improvement, slight improvement, no change, slight worsening, moderate worsening, marked worsening, not done. The GES is a 7-point scale wherein 7 categories are ranked from 1 (marked improvement from previous visit) to 7 (marked worsening from previous visit).

Outcome measures

Outcome measures
Measure	N159 PBO/LEV n=69 Participants Subjects had previously participated in study N159 in which they had received Placebo (PBO).	N159 LEV/LEV n=81 Participants Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).	N01010+N151 LEV/LEV n=41 Participants Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).	N01052 LEV/LEV n=13 Participants Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Marked improvement	8.7 percentage of participants	7.4 percentage of participants	4.9 percentage of participants	7.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Moderate improvement	14.5 percentage of participants	8.6 percentage of participants	12.2 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Slight improvement	15.9 percentage of participants	6.2 percentage of participants	14.6 percentage of participants	7.7 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit No change	34.8 percentage of participants	58.0 percentage of participants	51.2 percentage of participants	69.2 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Slight worsening	17.4 percentage of participants	13.6 percentage of participants	4.9 percentage of participants	15.4 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Moderate worsening	0.0 percentage of participants	3.7 percentage of participants	4.9 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Marked worsening	5.8 percentage of participants	1.2 percentage of participants	7.3 percentage of participants	0.0 percentage of participants
Percentage of Subjects in Categories of Parent/Legal Guardian's Rating of Change to Previous Visit in Global Evaluation Scale at Final Visit Not done	2.9 percentage of participants	1.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

Adverse Events

N159 PBO/LEV

Serious events: 20 serious events

Other events: 77 other events

Deaths: 0 deaths

N159 LEV/LEV

Serious events: 35 serious events

Other events: 86 other events

Deaths: 1 deaths

N01010+N151 LEV/LEV

Serious events: 12 serious events

Other events: 41 other events

Deaths: 0 deaths

N01052 LEV/LEV

Serious events: 7 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60