Trial Outcomes & Findings for Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy (NCT NCT01364597)

NCT ID: NCT01364597

Last Updated: 2025-10-17

Results Overview

TEAEs are defined as AEs that had onset on or after the day of first BRV dose.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

257 participants

Primary outcome timeframe

From Baseline to end of study (up to 10 years)

Results posted on

2025-10-17

Participant Flow

The study started to enroll participants in August 2011 and concluded in February 2022.

The Participant Flow refers to the Enrolled Set.

Participant milestones

Participant milestones
Measure	Age Cohort: ≥1 Month to <2 Years Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Study STARTED	36	15	141	65
Overall Study Directly Enrolled (DE) Participants	0	0	85	35
Overall Study Long-term Follow-up (LTFU) Participants	36	15	56	30
Overall Study COMPLETED	18	4	65	37
Overall Study NOT COMPLETED	18	11	76	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Age Cohort: ≥1 Month to <2 Years Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Study Adverse Event	4	5	16	7
Overall Study Lack of Efficacy	4	4	23	8
Overall Study Protocol Violation	0	0	2	0
Overall Study Lost to Follow-up	0	0	5	3
Overall Study Withdrawal by Subject	4	1	18	6
Overall Study Non compliance	1	0	1	0
Overall Study Lack of compliance	1	0	0	0
Overall Study End of treatment epilepsy	1	0	0	0
Overall Study No Seizures	1	0	0	0
Overall Study Lack of reliability from the subject's caregiver	1	0	0	0
Overall Study Cure	1	0	0	0
Overall Study Patient was moving	0	1	0	0
Overall Study Seizures resolved	0	0	1	0
Overall Study Patient became seizure-free after surgery	0	0	1	0
Overall Study 5 year without seizures. Treatment is finish	0	0	1	0
Overall Study Patient cured from Epilepsy	0	0	1	0
Overall Study Investigator decision	0	0	1	0
Overall Study Sponsor recommended discontinuation	0	0	0	1
Overall Study Parents went abroad with the patient	0	0	1	0
Overall Study BRV discontinued as no seizures during 2 years	0	0	1	0
Overall Study BRV administration dropout	0	0	1	0
Overall Study Dropout	0	0	3	1
Overall Study Unreliable subject	0	0	0	1
Overall Study Other	0	0	0	1

Baseline Characteristics

Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age Cohort: ≥1 Month to <2 Years n=36 Participants Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years n=15 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years n=141 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years n=65 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Total n=257 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=99 Participants	15 Participants n=107 Participants	141 Participants n=206 Participants	65 Participants n=7 Participants	257 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Continuous	1.122 years STANDARD_DEVIATION 0.504 • n=99 Participants	2.761 years STANDARD_DEVIATION 0.582 • n=107 Participants	7.699 years STANDARD_DEVIATION 2.394 • n=206 Participants	13.824 years STANDARD_DEVIATION 1.274 • n=7 Participants	8.039 years STANDARD_DEVIATION 4.529 • n=31 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	5 Participants n=107 Participants	62 Participants n=206 Participants	30 Participants n=7 Participants	116 Participants n=31 Participants
Sex: Female, Male Male	17 Participants n=99 Participants	10 Participants n=107 Participants	79 Participants n=206 Participants	35 Participants n=7 Participants	141 Participants n=31 Participants
Race/Ethnicity, Customized American Indian/ Alaskan native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race/Ethnicity, Customized Black	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race/Ethnicity, Customized White	28 Participants n=99 Participants	14 Participants n=107 Participants	107 Participants n=206 Participants	48 Participants n=7 Participants	197 Participants n=31 Participants
Race/Ethnicity, Customized Other/Mixed	8 Participants n=99 Participants	1 Participants n=107 Participants	32 Participants n=206 Participants	15 Participants n=7 Participants	56 Participants n=31 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=99 Participants	1 Participants n=107 Participants	38 Participants n=206 Participants	19 Participants n=7 Participants	69 Participants n=31 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	24 Participants n=99 Participants	14 Participants n=107 Participants	103 Participants n=206 Participants	46 Participants n=7 Participants	187 Participants n=31 Participants
Race/Ethnicity, Customized Missing	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: From Baseline to end of study (up to 10 years)

Population: The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication.

TEAEs are defined as AEs that had onset on or after the day of first BRV dose.

Outcome measures

Outcome measures
Measure	Age Cohort: ≥1 Month to <2 Years n=36 Participants Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years n=15 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years n=141 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years n=65 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study	94.4 percentage of participants	93.3 percentage of participants	93.6 percentage of participants	92.3 percentage of participants

PRIMARY outcome

Timeframe: From Baseline to end of study (up to 10 years)

Population: The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication.

TEAEs are defined as AEs that had onset on or after the day of first BRV dose. A SAE was defined as an event that met 1 or more of the below criteria: a) Death, b) Life-threatening, (Life-threatening did not include a reaction that might have caused death had it occurred in a more severe form.) c) Significant or persistent disability/incapacity, d) Congenital anomaly/birth defect (including that occurring in a fetus), e) Important medical event that, based upon appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious, (Important medical events may have included allergic bronchospasm requiring intensive treatment in an emergency room \[ER\] or at home) f) Initial inpatient hospitalization or prolongation of hospitalization. (A participant admitted to a hospital, even if released on the same day, met the criteria for the initial inpatient hospitalization).

Outcome measures

Outcome measures
Measure	Age Cohort: ≥1 Month to <2 Years n=36 Participants Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years n=15 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years n=141 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years n=65 Participants Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study	38.9 percentage of participants	53.3 percentage of participants	29.8 percentage of participants	29.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Population: FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (≥2 years only \[per DRC data\]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for \<2 years) from which their seizure data is recorded.

Absolute change in seizure frequency per 28 days based on the daily record card (DRC) data, is calculated as baseline seizure frequency per 28 days minus post-Baseline seizure frequency per 28 days. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only. Here in the study FAS indicates Full Analysis Set, EEG indicates electroencephalogram, OM indicates Outcome measure

Outcome measures

Outcome measures
Measure	Age Cohort: ≥1 Month to <2 Years n=134 Participants Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC])	-37.48 seizure frequency per 28-days Standard Deviation 628.34	—	—	—

SECONDARY outcome

Timeframe: From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Percent change is calculated as absolute change in seizure frequency per 28 days divided by baseline seizure frequency per 28 Days multiplied to 100. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only.

Outcome measures

Outcome measures
Measure	Age Cohort: ≥1 Month to <2 Years n=105 Participants Participants from core study (LTFU \[Long term follow-up\] participants from N01263 \[NCT00422422\], EP0065 \[NCT03405714\] or N01349 \[NCT03325439\]) aged greater than or equal to (≥) 1 month to less than (\<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily\[bid\]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Age Cohort: ≥2 to <4 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥2 Years to \<4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥4 to <12 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥4 Years to \<12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to \<12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Age Cohort: ≥12 to <17 Years Participants from core study (LTFU participants from N01263 \[NCT00422422\] and EP0065 \[NCT03405714\]) aged ≥12 Years to \<17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to \<17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data)	26.57 percent change Standard Deviation 123.06	—	—	—

SECONDARY outcome

Timeframe: From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Population: FAS: all enrolled participants who took at least 1 dose of study drug in this Long-term study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed included all participants evaluable for this OM. Per planned analysis, participants were grouped as per cohort linked to source (DRC for ≥2 years /EEG for \<2 years) from which their seizure data is recorded. This OM was analyzed in participants ≥2 years of age (per DRC data) only.

A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants or during this study for DE participants. This OM was analyzed in participants ≥2 years (per DRC data) only.