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

• ClinicalTrials.gov Identifier: NCT03405714
• Recruitment Status: Completed
• First Posted: January 23, 2018
• Results First Posted: November 26, 2021
• Last Update Posted: May 11, 2022
• Sponsor: UCB Biopharma S.P.R.L.
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Brivaracetam
• Enrollment: 50

Participant Flow

Recruitment Details	The study started to enroll participants in June 2018 and concluded in November 2020.
Pre-assignment Details	Participant Flow refers to the Safety Set-Intravenous (SS-iv).

Arm/Group Title	Age Cohort: >=12 to <16 Years	Age Cohort: >=6 to <12 Years	Age Cohort: >=2 to <6 Years	Age Cohort: >=1 Month to <2 Years
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
Started	12	12	13	13
Completed	12	12	13	13
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Age Cohort: >=12 to <16 Years	Age Cohort: >=6 to <12 Years	Age Cohort: >=2 to <6 Years	Age Cohort: >=1 Month to <2 Years	Total Title
Arm/Group Description		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.	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.	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.	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.	[Not Specified]
Overall Number of Baseline Participants		12	12	13	13	50
Baseline Analysis Population Description		Baseline Characteristics refer to SS-iv, which included study participants who received at least 1 dose of iv BRV.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	13 participants	13 participants	50 participants
	<=18 years	12 100.0%	12 100.0%	13 100.0%	13 100.0%	50 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants	12 participants	13 participants	13 participants	50 participants
		13.08 (1.16)	8.33 (1.61)	3.85 (0.99)	0.95 (0.59)	6.39 (4.76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	13 participants	13 participants	50 participants
	Female	6 50.0%	8 66.7%	5 38.5%	5 38.5%	24 48.0%
	Male	6 50.0%	4 33.3%	8 61.5%	8 61.5%	26 52.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants	12 participants	13 participants	13 participants	50 participants
	American Indian/Alaskan Native	0 0.0%	0 0.0%	0 0.0%	2 15.4%	2 4.0%
	Black	1 8.3%	0 0.0%	0 0.0%	0 0.0%	1 2.0%
	White	11 91.7%	12 100.0%	13 100.0%	11 84.6%	47 94.0%

Outcome Measures

1. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	12	10	10	9
Geometric Mean (95% Confidence Interval); Unit of Measure: nanograms per milliliter (ng/mL)
	149.0; (27.6 to 805.1)	NA [1]; (NA to NA)	NA [1]; (NA to NA)	310.6; (92.5 to 1042.7)

[1]

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).

2. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	12	10	8	10
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1844.6; (1110.4 to 3064.3)	2058.8; (1726.4 to 2455.2)	1774.9; (1087.4 to 2897.1)	1566.6; (973.1 to 2522.2)

3. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	12	10	11	9
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1260.6; (962.6 to 1650.8)	1189.5; (1005.5 to 1407.1)	1225.3; (676.8 to 2218.6)	1341.7; (657.9 to 2735.9)

4. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	3	0	0
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		290.5; (101.2 to 834.0)

5. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	3	0	0
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		2084.3; (681.2 to 6377.0)

6. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	3	0	0
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		1149.8; (613.1 to 2156.4)

7. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	1	2	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		466.0 [1]; (NA to NA)	204.5; (0.1 to 383063.7)	482.9; (4.8 to 48506.1)

[1]

'NA' signifies that 95% CI could not be calculated for a single participant.

8. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	1	3	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		2890.0 [1]; (NA to NA)	1948.8; (690.8 to 5497.7)	2072.4; (743.2 to 5778.8)

[1]

'NA' signifies that 95% CI could not be calculated for a single participant.

9. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Age Cohort: >=12 to <16 Years (PK-PPS)	Age Cohort: >=6 to <12 Years (PK-PPS)	Age Cohort: >=2 to <6 Years (PK-PPS)	Age Cohort : >=1 Month to <2 Years (PK-PPS)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	0	1	2	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
		1820 [1]; (NA to NA)	1203.5; (147.1 to 9847.1)	727.4; (144.9 to 3652.9)

[1]

'NA' signifies that 95% CI could not be calculated for a single participant.

10. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	19
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	NA [1]; (NA to NA)

[1]

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).

11. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	21
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1903.0; (1474.9 to 2455.4)

12. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	21
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1130.3; (882.1 to 1448.3)

13. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	290.5; (101.2 to 834.0)

14. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	2084.3; (681.2 to 6377.0)

15. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1149.8; (613.1 to 2156.4)

16. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	776.0; (51.9 to 11611.3)

17. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	4
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	2697.8; (1911.1 to 3808.3)

18. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	15-minute Infusion (PK-PPS)
Arm/Group Description:	Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). 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. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	4
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1030.0; (376.1 to 2820.9)

19. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	22
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	120.5; (44.7 to 325.2)

20. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	19
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1704.8; (1237.5 to 2348.4)

21. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	21
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1383.9; (989.3 to 1935.8)

22. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

23. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

24. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

25. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	167.5; (9.6 to 2932.2)

26. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	3
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	1531.8; (837.3 to 2802.2)

27. Primary Outcome

Title	Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus
Description	Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.
Time Frame	Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bolus (PK-PPS)
Arm/Group Description:	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 second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS.
Overall Number of Participants Analyzed	2
Geometric Mean (95% Confidence Interval); Unit of Measure: ng/mL
	949.5; (2.8 to 316987.2)

28. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	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.
Time Frame	From Screening until last visit (up to Day 68)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Age Cohort: >=12 to <16 Years (SS-iv)	Age Cohort: >=6 to <12 Years (SS-iv)	Age Cohort: >=2 to <6 Years (SS-iv)	Age Cohort: >=1 Month to <2 Years (SS-iv)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	12	12	13	13
Measure Type: Count of Participants; Unit of Measure: Participants
	3 25.0%	4 33.3%	7 53.8%	2 15.4%

29. Primary Outcome

Title	Number of Participant Withdrawals Due to Adverse Events
Description	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.
Time Frame	From Screening until last visit (up to Day 68)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Age Cohort: >=12 to <16 Years (SS-iv)	Age Cohort: >=6 to <12 Years (SS-iv)	Age Cohort: >=2 to <6 Years (SS-iv)	Age Cohort: >=1 Month to <2 Years (SS-iv)
Arm/Group Description:	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).	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.	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.	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.
Overall Number of Participants Analyzed	12	12	13	13
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Adverse Events

Time Frame	From Screening until last visit (up to Day 68)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Age Cohort: >=12 to <16 Years (SS-iv)		Age Cohort: >=6 to <12 Years (SS-iv)		Age Cohort: >=2 to <6 Years (SS-iv)		Age Cohort: >=1 Month to <2 Years (SS-iv)
Arm/Group Description	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).		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.		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.		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.
All-Cause Mortality
	Age Cohort: >=12 to <16 Years (SS-iv)		Age Cohort: >=6 to <12 Years (SS-iv)		Age Cohort: >=2 to <6 Years (SS-iv)		Age Cohort: >=1 Month to <2 Years (SS-iv)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/12 (0.00%)		0/12 (0.00%)		0/13 (0.00%)		0/13 (0.00%)
Serious Adverse Events
	Age Cohort: >=12 to <16 Years (SS-iv)		Age Cohort: >=6 to <12 Years (SS-iv)		Age Cohort: >=2 to <6 Years (SS-iv)		Age Cohort: >=1 Month to <2 Years (SS-iv)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0.00%)		0/12 (0.00%)		0/13 (0.00%)		1/13 (7.69%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/13 (0.00%)	0	1/13 (7.69%)	1
1 Term from vocabulary, MedDRA18.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Age Cohort: >=12 to <16 Years (SS-iv)		Age Cohort: >=6 to <12 Years (SS-iv)		Age Cohort: >=2 to <6 Years (SS-iv)		Age Cohort: >=1 Month to <2 Years (SS-iv)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25.00%)		4/12 (33.33%)		7/13 (53.85%)		2/13 (15.38%)
Gastrointestinal disorders
Vomiting * 1	0/12 (0.00%)	0	1/12 (8.33%)	1	0/13 (0.00%)	0	0/13 (0.00%)	0
General disorders
Fatigue * 1	0/12 (0.00%)	0	1/12 (8.33%)	1	1/13 (7.69%)	1	0/13 (0.00%)	0
Pyrexia * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	2/13 (15.38%)	2	0/13 (0.00%)	0
Vessel puncture site haemorrhage * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	1/13 (7.69%)	1	0/13 (0.00%)	0
Infections and infestations
Conjunctivitis * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	1/13 (7.69%)	1	0/13 (0.00%)	0
Ear infection * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	2/13 (15.38%)	2	0/13 (0.00%)	0
Nasopharyngitis * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	1/13 (7.69%)	1	0/13 (0.00%)	0
Pharyngitis * 1	1/12 (8.33%)	1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/13 (0.00%)	0
Upper respiratory tract infection * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/13 (0.00%)	0	1/13 (7.69%)	1
Nervous system disorders
Dizziness * 1	2/12 (16.67%)	2	0/12 (0.00%)	0	0/13 (0.00%)	0	0/13 (0.00%)	0
Somnolence * 2	0/12 (0.00%)	0	0/12 (0.00%)	0	2/13 (15.38%)	2	1/13 (7.69%)	1
Psychiatric disorders
Aggression * 1	0/12 (0.00%)	0	0/12 (0.00%)	0	1/13 (7.69%)	1	0/13 (0.00%)	0
Insomnia * 1	0/12 (0.00%)	0	1/12 (8.33%)	1	0/13 (0.00%)	0	0/13 (0.00%)	0
Skin and subcutaneous tissue disorders
Pruritus * 1	0/12 (0.00%)	0	1/12 (8.33%)	1	0/13 (0.00%)	0	0/13 (0.00%)	0
Rash * 1	0/12 (0.00%)	0	1/12 (8.33%)	1	1/13 (7.69%)	1	0/13 (0.00%)	0
1 Term from vocabulary, MedDRA18.1; 2 Term from vocabulary, MedDR; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Farkas MK, Kang H, Fogarasi A, Bozorg A, James GD, Krauwinkel W, Morita D, Will E, Elshoff JP. Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial. Epilepsia. 2022 Apr;63(4):855-864. doi: 10.1111/epi.17187. Epub 2022 Feb 23.

• Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
• ClinicalTrials.gov Identifier: NCT03405714
• Other Study ID Numbers: EP0065; 2016-002452-25 ( EudraCT Number )
• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Results First Submitted: September 8, 2021
• Results First Posted: November 26, 2021
• Last Update Posted: May 11, 2022