Clinical Trial Results:
A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Summary
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EudraCT number |
2016-002452-25 |
Trial protocol |
ES HU CZ DE IT |
Global end of trial date |
04 Nov 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
20 May 2021
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First version publication date |
20 May 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EP0065
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03405714 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UCB Biopharma SRL
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Sponsor organisation address |
Allée de la Recherche 60, Brussels, Belgium, 1070
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Public contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Scientific contact |
Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Nov 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Nov 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the pharmacokinetics (PK), safety, and tolerability of Brivaracetam (BRV) administered intravenously (iv) in subjects greater than or equal to (>=) 1 month to less than (<) 16 years of age with epilepsy.
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Protection of trial subjects |
During the conduct of the study all participants were closely monitored.
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Background therapy |
Background therapy as permitted in the protocol. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
01 Jun 2018
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy, Safety | ||
Long term follow-up duration |
3 Years | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Mexico: 2
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Country: Number of subjects enrolled |
United States: 4
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Country: Number of subjects enrolled |
Germany: 1
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Country: Number of subjects enrolled |
Hungary: 30
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Country: Number of subjects enrolled |
Italy: 4
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Country: Number of subjects enrolled |
Spain: 5
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Country: Number of subjects enrolled |
Czechia: 4
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Worldwide total number of subjects |
50
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EEA total number of subjects |
44
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
13
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Children (2-11 years) |
25
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Adolescents (12-17 years) |
12
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study started to enroll participants in June 2018 and concluded in November 2020. | |||||||||||||||
Pre-assignment
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Screening details |
Participant Flow refers to the Safety Set-Intravenous (SS-iv). | |||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Age Cohort: >=12 to <16 years | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Brivaracetam-Solution for iv injection
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Investigational medicinal product code |
BRV
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Other name |
UCB 34714
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Brivaracetam (BRV) was administered as a 15-minute infusion or bolus (up to 2- minute infusion) every 12 hours in IV PK Period (1-6 days).
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Arm title
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Age Cohort: >=6 to <12 years | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Brivaracetam-Solution for iv injection
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Investigational medicinal product code |
BRV
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Other name |
UCB 34714
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Brivaracetam (BRV) was administered as a 15-minute infusion or bolus (up to 2- minute infusion) every 12 hours in IV PK Period (1-6 days).
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Arm title
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Age Cohort: >=2 to <6 years | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Brivaracetam-Solution for iv injection
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Investigational medicinal product code |
BRV
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Other name |
UCB 34714
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Brivaracetam (BRV) was administered as a 15-minute infusion or bolus (up to 2- minute infusion) every 12 hours in IV PK Period (1-6 days).
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Arm title
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Age Cohort: >=1 month to <2 years | |||||||||||||||
Arm 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. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Brivaracetam-Solution for iv injection
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Investigational medicinal product code |
BRV
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Other name |
UCB 34714
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Brivaracetam (BRV) was administered as a 15-minute infusion or bolus (up to 2- minute infusion) every 12 hours in IV PK Period (1-6 days).
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Baseline characteristics reporting groups
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Reporting group title |
Age Cohort: >=12 to <16 years
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=6 to <12 years
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=2 to <6 years
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=1 month to <2 years
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Age Cohort: >=12 to <16 years
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Reporting 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. | ||
Reporting group title |
Age Cohort: >=6 to <12 years
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Reporting 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. | ||
Reporting group title |
Age Cohort: >=2 to <6 years
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Reporting 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. | ||
Reporting group title |
Age Cohort: >=1 month to <2 years
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Reporting 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. | ||
Subject analysis set title |
Age Cohort: >=12 to <16 years (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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).
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Subject analysis set title |
Age Cohort: >=6 to <12 years (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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 PK-PPS.
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Subject analysis set title |
Age Cohort: >=2 to <6 years (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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 PK-PPS.
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Subject analysis set title |
Age Cohort : >=1 month to <2 years (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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 PK-PPS.
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Subject analysis set title |
15-minute Infusion (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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.
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Subject analysis set title |
Bolus (PK-PPS)
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Subject analysis set type |
Per protocol | ||
Subject analysis set 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.
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Subject analysis set title |
Age Cohort: >=12 to <16 years (SS-iv)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set 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).
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Subject analysis set title |
Age Cohort: >=6 to <12 years (SS-iv)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set 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 SS-iv.
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Subject analysis set title |
Age Cohort: >=2 to <6 years (SS-iv)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set 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 SS-iv.
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Subject analysis set title |
Age Cohort: >=1 month to <2 years (SS-iv)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set 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 SS-iv.
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End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3 [1] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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. 999 is used as a placeholder for Age Cohort >=6 to <12 years and >=2 to <6 years because 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).
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End point type |
Primary
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End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3 [2] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3
|
||||||||||||||||||||
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3 [3] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3
|
||||||||||||||||||||
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4 [4] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4
|
||||||||||||||||||||
Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [5] - PK samples were not collected at Visit 4 in >=12 to <16 years patients. [6] - PK samples were not collected at Visit 4 in >=2 to <6 years patients. [7] - PK samples were not collected at Visit 4 in >=1 to <2 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4 [8] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4
|
||||||||||||||||||||
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [9] - PK samples were not collected at Visit 4 in >=12 to <16 years patients. [10] - PK samples were not collected at Visit 4 in >=2 to <6 years patients. [11] - PK samples were not collected at Visit 4 in >=1 to <2 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4 [12] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4
|
||||||||||||||||||||
Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [13] - PK samples were not collected at Visit 4 in >=12 to <16 years patients. [14] - PK samples were not collected at Visit 4 in >=2 to <6 years patients. [15] - PK samples were not collected at Visit 4 in >=1 to <2 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5 [16] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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. 99/999 is used as a placeholder for Age Cohort >=6 to <12 years because 95% CI could not be calculated for a single participant.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5
|
||||||||||||||||||||
Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [17] - PK samples were not collected at Visit 5 in >=12 to <16 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5 [18] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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. 999/9999 is used as a placeholder for Age Cohort >=6 to <12 years because 95% CI could not be calculated for a single participant.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 15 minutes and post-initiation of iv BRV infusion at Visit 5
|
||||||||||||||||||||
Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [19] - PK samples were not collected at Visit 5 in >=12 to <16 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5 [20] | ||||||||||||||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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. 999/9999 is used as a placeholder for Age Cohort >=6 to <12 years because 95% CI could not be calculated for a single participant.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5
|
||||||||||||||||||||
Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||||||||||||||
|
|||||||||||||||||||||
Notes [21] - PK samples were not collected at Visit 5 in >=12 to <16 years patients. |
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3 by Infusion Duration - 15 Minutes [22] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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. 999 is used as a placeholder because 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).
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3
|
||||||||
Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3 by Infusion Duration- 15 Minutes [23] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3
|
||||||||
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3 by Infusion Duration- 15 Minutes [24] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3
|
||||||||
Notes [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4 by Infusion Duration- 15 Minutes [25] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4
|
||||||||
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4 by Infusion Duration- 15 Minutes [26] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4
|
||||||||
Notes [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4 by Infusion Duration- 15 Minutes [27] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4
|
||||||||
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5 by Infusion Duration- 15 Minutes [28] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5
|
||||||||
Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5 by Infusion Duration- 15 Minutes [29] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5
|
||||||||
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5 by Infusion Duration- 15 Minutes [30] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5
|
||||||||
Notes [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3 by Infusion Duration- Bolus [31] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3
|
||||||||
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3 by Infusion Duration- Bolus [32] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3
|
||||||||
Notes [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3 by Infusion Duration- Bolus [33] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3
|
||||||||
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4 by Infusion Duration- Bolus [34] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4
|
||||||||
Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
Notes [35] - PK samples were not collected at Visit 4 in bolus patients. |
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4 by Infusion Duration- Bolus [36] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 15 minutes post-initiation of iv BRV infusion at Visit 4
|
||||||||
Notes [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
Notes [37] - PK samples were not collected at Visit 4 in bolus patients. |
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4 by Infusion Duration- Bolus [38] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
At 3 hours post-initiation of iv BRV infusion at Visit 4
|
||||||||
Notes [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
Notes [39] - PK samples were not collected at Visit 4 in bolus patients. |
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5 by Infusion Duration- Bolus [40] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5
|
||||||||
Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5 by Infusion Duration- Bolus [41] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5
|
||||||||
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5 by Infusion Duration- Bolus [42] | ||||||||
End point description |
Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. 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.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5
|
||||||||
Notes [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of Participants With Adverse Events (AEs) [43] | |||||||||||||||
End point 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. The SS-iv included study participants who received at least 1 dose of iv BRV.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
From Screening until last visit (up to Day 68)
|
|||||||||||||||
Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of Participant Withdrawals due to Adverse Events [44] | |||||||||||||||
End point 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. The SS-iv included study participants who received at least 1 dose of iv BRV.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
From Screening until last visit (up to Day 68)
|
|||||||||||||||
Notes [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
From Screening until last visit (up to Day 68)
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
|
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Reporting groups
|
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Reporting group title |
Age Cohort: >=12 to <16 years (SS-iv)
|
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Reporting 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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=2 to <6 years (SS-iv)
|
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Reporting 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 SS-iv. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=1 month to <2 years (SS-iv)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting 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 SS-iv. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Cohort: >=6 to <12 years (SS-iv)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting 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 SS-iv. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |