Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy (NCT NCT03405714)

Results Overview

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Results posted on

2022-05-11

Participant Flow

The study started to enroll participants in June 2018 and concluded in November 2020.

Participant Flow refers to the Safety Set-Intravenous (SS-iv).

Participant milestones

Participant milestones
Measure	Age Cohort: >=12 to <16 Years Screening Period (1-10 days): Participants receiving open-label BRV (OLB) or prescribed oral BRV (RxB) continued to receive oral BRV. IOB Treatment Period (2-10 days): Participants who initiated Oral BRV (IOB) continued with oral BRV 2 milligram/kilogram/day (mg/kg/day). IV PK (Intravenous Pharmacokinetic) Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv Brivaracetam (BRV) dose was equivalent to final dose of oral BRV and for Initiating iv BRV (IIB) participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=6 to <12 Years Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=2 to <6 Years Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=1 Month to <2 Years Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.
Overall Study STARTED	12	12	13	13
Overall Study COMPLETED	12	12	13	13
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age Cohort: >=12 to <16 Years n=12 Participants Screening Period (1-10 days): Participants receiving open-label BRV (OLB) or prescribed oral BRV (RxB) continued to receive oral BRV. IOB Treatment Period (2-10 days): Participants who initiated Oral BRV (IOB) continued with oral BRV 2 milligram/kilogram/day (mg/kg/day). IV PK (Intravenous Pharmacokinetic) Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv Brivaracetam (BRV) dose was equivalent to final dose of oral BRV and for Initiating iv BRV (IIB) participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=6 to <12 Years n=12 Participants Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=2 to <6 Years n=13 Participants Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Age Cohort: >=1 Month to <2 Years n=13 Participants Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day.	Total Title n=50 Participants
Age, Categorical <=18 years	12 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants	50 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	13.08 years STANDARD_DEVIATION 1.16 • n=5 Participants	8.33 years STANDARD_DEVIATION 1.61 • n=7 Participants	3.85 years STANDARD_DEVIATION 0.99 • n=5 Participants	0.95 years STANDARD_DEVIATION 0.59 • n=4 Participants	6.39 years STANDARD_DEVIATION 4.76 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	24 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	26 Participants n=21 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	47 Participants n=21 Participants

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=10 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=10 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=9 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3	149.0 nanograms per milliliter (ng/mL) Interval 27.6 to 805.1	NA nanograms per milliliter (ng/mL) Geometric mean and 95% CI were only calculated if at least two-thirds of the data were greater than the lower Limit of quantification (LOQ).	NA nanograms per milliliter (ng/mL) Geometric mean and 95% CI were only calculated if at least two-thirds of the data were greater than the lower Limit of quantification (LOQ).	310.6 nanograms per milliliter (ng/mL) Interval 92.5 to 1042.7

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=10 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=8 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=10 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3	1844.6 ng/mL Interval 1110.4 to 3064.3	2058.8 ng/mL Interval 1726.4 to 2455.2	1774.9 ng/mL Interval 1087.4 to 2897.1	1566.6 ng/mL Interval 973.1 to 2522.2

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=10 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=11 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=9 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3	1260.6 ng/mL Interval 962.6 to 1650.8	1189.5 ng/mL Interval 1005.5 to 1407.1	1225.3 ng/mL Interval 676.8 to 2218.6	1341.7 ng/mL Interval 657.9 to 2735.9

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in \>=12 to \<16 years, \>=2 to \<6 years, and \>=1 to \<2 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4	—	290.5 ng/mL Interval 101.2 to 834.0	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in \>=12 to \<16 years, \>=2 to \<6 years, and \>=1 to \<2 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4	—	2084.3 ng/mL Interval 681.2 to 6377.0	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in \>=12 to \<16 years, \>=2 to \<6 years, and \>=1 to \<2 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4	—	1149.8 ng/mL Interval 613.1 to 2156.4	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in \>=12 to \<16 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=1 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=2 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5	—	466.0 ng/mL 'NA' signifies that 95% CI could not be calculated for a single participant.	204.5 ng/mL Interval 0.1 to 383063.7	482.9 ng/mL Interval 4.8 to 48506.1

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in \>=12 to \<16 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=1 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5	—	2890.0 ng/mL 'NA' signifies that 95% CI could not be calculated for a single participant.	1948.8 ng/mL Interval 690.8 to 5497.7	2072.4 ng/mL Interval 743.2 to 5778.8

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in \>=12 to \<16 years patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=1 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=2 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5	—	1820 ng/mL 'NA' signifies that 95% CI could not be calculated for a single participant.	1203.5 ng/mL Interval 147.1 to 9847.1	727.4 ng/mL Interval 144.9 to 3652.9

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=19 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes	NA ng/mL Geometric mean and 95% CI were only calculated if at least two-thirds of the data were greater than the lower Limit of quantification (LOQ).	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=21 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes	1903.0 ng/mL Interval 1474.9 to 2455.4	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=21 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes	1130.3 ng/mL Interval 882.1 to 1448.3	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes	290.5 ng/mL Interval 101.2 to 834.0	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes	2084.3 ng/mL Interval 681.2 to 6377.0	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes	1149.8 ng/mL Interval 613.1 to 2156.4	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes	776.0 ng/mL Interval 51.9 to 11611.3	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=4 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes	2697.8 ng/mL Interval 1911.1 to 3808.3	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=4 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes	1030.0 ng/mL Interval 376.1 to 2820.9	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=22 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus	120.5 ng/mL Interval 44.7 to 325.2	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=19 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus	1704.8 ng/mL Interval 1237.5 to 2348.4	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=21 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus	1383.9 ng/mL Interval 989.3 to 1935.8	—	—	—

PRIMARY outcome

Timeframe: At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus	167.5 ng/mL Interval 9.6 to 2932.2	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=3 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus	1531.8 ng/mL Interval 837.3 to 2802.2	—	—	—

PRIMARY outcome

Timeframe: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Population: The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment.

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=2 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus	949.5 ng/mL Interval 2.8 to 316987.2	—	—	—

PRIMARY outcome

Timeframe: From Screening until last visit (up to Day 68)

Population: The SS-iv included study participants who received at least 1 dose of iv BRV.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=13 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=13 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Number of Participants With Adverse Events (AEs)	3 Participants	4 Participants	7 Participants	2 Participants

PRIMARY outcome

Timeframe: From Screening until last visit (up to Day 68)

Population: The SS-iv included study participants who received at least 1 dose of iv BRV.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Age Cohort: >=12 to <16 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS).	Age Cohort: >=6 to <12 Years (PK-PPS) n=12 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort: >=2 to <6 Years (PK-PPS) n=13 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.	Age Cohort : >=1 Month to <2 Years (PK-PPS) n=13 Participants Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS.
Number of Participant Withdrawals Due to Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Age Cohort: >=12 to <16 Years (SS-iv)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Age Cohort: >=6 to <12 Years (SS-iv)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Age Cohort: >=2 to <6 Years (SS-iv)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Age Cohort: >=1 Month to <2 Years (SS-iv)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Age Cohort: >=12 to <16 Years (SS-iv) n=12 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv).	Age Cohort: >=6 to <12 Years (SS-iv) n=12 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.	Age Cohort: >=2 to <6 Years (SS-iv) n=13 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety SS-iv.	Age Cohort: >=1 Month to <2 Years (SS-iv) n=13 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)

Other adverse events

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Age Cohort: >=12 to <16 Years (SS-iv) n=12 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv).	Age Cohort: >=6 to <12 Years (SS-iv) n=12 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.	Age Cohort: >=2 to <6 Years (SS-iv) n=13 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety SS-iv.	Age Cohort: >=1 Month to <2 Years (SS-iv) n=13 participants at risk Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv.
Gastrointestinal disorders Vomiting	0.00% 0/12 • From Screening until last visit (up to Day 68)	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
General disorders Fatigue	0.00% 0/12 • From Screening until last visit (up to Day 68)	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
General disorders Pyrexia	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	15.4% 2/13 • Number of events 2 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
General disorders Vessel puncture site haemorrhage	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Infections and infestations Conjunctivitis	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Infections and infestations Ear infection	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	15.4% 2/13 • Number of events 2 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Infections and infestations Nasopharyngitis	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Infections and infestations Pharyngitis	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)
Nervous system disorders Dizziness	16.7% 2/12 • Number of events 2 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Nervous system disorders Somnolence	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	15.4% 2/13 • Number of events 2 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)
Psychiatric disorders Aggression	0.00% 0/12 • From Screening until last visit (up to Day 68)	0.00% 0/12 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Psychiatric disorders Insomnia	0.00% 0/12 • From Screening until last visit (up to Day 68)	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/12 • From Screening until last visit (up to Day 68)	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)
Skin and subcutaneous tissue disorders Rash	0.00% 0/12 • From Screening until last visit (up to Day 68)	8.3% 1/12 • Number of events 1 • From Screening until last visit (up to Day 68)	7.7% 1/13 • Number of events 1 • From Screening until last visit (up to Day 68)	0.00% 0/13 • From Screening until last visit (up to Day 68)