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    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
    EudraCT number
    2016-002452-25
    Trial protocol
    ES   HU   CZ   DE   IT  
    Global end of trial date
    04 Nov 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    20 May 2021
    First version publication date
    20 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP0065
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03405714
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    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.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Jun 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    50
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    13
    Children (2-11 years)
    25
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set-Intravenous (SS-iv).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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
    Investigational medicinal product code
    BRV
    Other name
    UCB 34714
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    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).

    Arm title
    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
    Investigational medicinal product code
    BRV
    Other name
    UCB 34714
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    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).

    Arm title
    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
    Investigational medicinal product code
    BRV
    Other name
    UCB 34714
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    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).

    Arm title
    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
    Investigational medicinal product code
    BRV
    Other name
    UCB 34714
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    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).

    Number of subjects in period 1
    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
    Started
    12
    12
    13
    13
    Completed
    12
    12
    13
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age Cohort: >=12 to <16 years
    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
    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
    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
    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 values
    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
    Number of subjects
    12 12 13 13 50
    Age categorical
    Units: Subjects
        <=18 years
    12 12 13 13 50
        Between 18 and 65 years
    0 0 0 0 0
        >=65 years
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    13.08 ± 1.16 8.33 ± 1.61 3.85 ± 0.99 0.95 ± 0.59 -
    Gender categorical
    Units: Subjects
        Female
    6 8 5 5 24
        Male
    6 4 8 8 26

    End points

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    End points reporting groups
    Reporting group title
    Age Cohort: >=12 to <16 years
    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
    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
    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
    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)
    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).

    Subject analysis set title
    Age Cohort: >=6 to <12 years (PK-PPS)
    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.

    Subject analysis set title
    Age Cohort: >=2 to <6 years (PK-PPS)
    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.

    Subject analysis set title
    Age Cohort : >=1 month to <2 years (PK-PPS)
    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.

    Subject analysis set title
    15-minute Infusion (PK-PPS)
    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.

    Subject analysis set title
    Bolus (PK-PPS)
    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.

    Subject analysis set title
    Age Cohort: >=12 to <16 years (SS-iv)
    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).

    Subject analysis set title
    Age Cohort: >=6 to <12 years (SS-iv)
    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.

    Subject analysis set title
    Age Cohort: >=2 to <6 years (SS-iv)
    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.

    Subject analysis set title
    Age Cohort: >=1 month to <2 years (SS-iv)
    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.

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3

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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).
    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
    [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.
    End point values
    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)
    Number of subjects analysed
    12
    10
    12
    11
    Units: nanograms per milliliter (ng/mL)
        geometric mean (confidence interval 95%)
    149.0 (27.6 to 805.1)
    999 (999 to 999)
    999 (999 to 999)
    310.6 (92.5 to 1042.7)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3

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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.
    End point values
    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)
    Number of subjects analysed
    12
    10
    8
    10
    Units: ng/mL
        geometric mean (confidence interval 95%)
    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)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3

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    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.
    End point values
    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)
    Number of subjects analysed
    12
    10
    11
    9
    Units: ng/mL
        geometric mean (confidence interval 95%)
    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)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [5]
    3
    0 [6]
    0 [7]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    290.5 (101.2 to 834.0)
    ( to )
    ( to )
    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

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [9]
    3
    0 [10]
    0 [11]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    2084.3 (681.2 to 6377.0)
    ( to )
    ( to )
    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

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [13]
    3
    0 [14]
    0 [15]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    1149.8 (613.1 to 2156.4)
    ( to )
    ( to )
    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

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [17]
    1
    2
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    466.0 (99 to 999)
    204.5 (0.1 to 383063.7)
    482.9 (4.8 to 48506.1)
    Notes
    [17] - PK samples were not collected at Visit 5 in >=12 to <16 years patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [19]
    1
    3
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    2890.0 (999 to 9999)
    1948.8 (690.8 to 5497.7)
    2072.4 (743.2 to 5778.8)
    Notes
    [19] - PK samples were not collected at Visit 5 in >=12 to <16 years patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5

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    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.
    End point values
    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)
    Number of subjects analysed
    0 [21]
    1
    2
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    1820 (999 to 9999)
    1203.5 (147.1 to 9847.1)
    727.4 (144.9 to 3652.9)
    Notes
    [21] - PK samples were not collected at Visit 5 in >=12 to <16 years patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3 by Infusion Duration - 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    19
    Units: ng/mL
        geometric mean (confidence interval 95%)
    999 (999 to 999)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    21
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1903.0 (1474.9 to 2455.4)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    21
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1130.3 (882.1 to 1448.3)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    290.5 (101.2 to 834.0)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    2084.3 (681.2 to 6377.0)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1149.8 (613.1 to 2156.4)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    776.0 (51.9 to 11611.3)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    4
    Units: ng/mL
        geometric mean (confidence interval 95%)
    2697.8 (1911.1 to 3808.3)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5 by Infusion Duration- 15 Minutes

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    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.
    End point values
    15-minute Infusion (PK-PPS)
    Number of subjects analysed
    4
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1030.0 (376.1 to 2820.9)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 3 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    22
    Units: ng/mL
        geometric mean (confidence interval 95%)
    120.5 (44.7 to 325.2)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 3 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    19
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1704.8 (1237.5 to 2348.4)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 3 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    21
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1383.9 (989.3 to 1935.8)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 4 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    0 [35]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [35] - PK samples were not collected at Visit 4 in bolus patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 4 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    0 [37]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [37] - PK samples were not collected at Visit 4 in bolus patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 4 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    0 [39]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [39] - PK samples were not collected at Visit 4 in bolus patients.
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 hour), Visit 5 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    167.5 (9.6 to 2932.2)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 minutes, Visit 5 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    3
    Units: ng/mL
        geometric mean (confidence interval 95%)
    1531.8 (837.3 to 2802.2)
    No statistical analyses for this end point

    Primary: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 hours, Visit 5 by Infusion Duration- Bolus

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    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.
    End point values
    Bolus (PK-PPS)
    Number of subjects analysed
    2
    Units: ng/mL
        geometric mean (confidence interval 95%)
    949.5 (2.8 to 316987.2)
    No statistical analyses for this end point

    Primary: Number of Participants With Adverse Events (AEs)

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    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.
    End point values
    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)
    Number of subjects analysed
    12
    12
    13
    13
    Units: participants
    3
    4
    7
    2
    No statistical analyses for this end point

    Primary: Number of Participant Withdrawals due to Adverse Events

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    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.
    End point values
    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)
    Number of subjects analysed
    12
    12
    13
    13
    Units: participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening until last visit (up to Day 68)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Age Cohort: >=12 to <16 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 Safety Set-Intravenous (SS-iv).

    Reporting group title
    Age Cohort: >=2 to <6 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 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.

    Serious adverse events
    Age Cohort: >=12 to <16 years (SS-iv) Age Cohort: >=2 to <6 years (SS-iv) Age Cohort: >=1 month to <2 years (SS-iv) Age Cohort: >=6 to <12 years (SS-iv)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Age Cohort: >=12 to <16 years (SS-iv) Age Cohort: >=2 to <6 years (SS-iv) Age Cohort: >=1 month to <2 years (SS-iv) Age Cohort: >=6 to <12 years (SS-iv)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    7 / 13 (53.85%)
    2 / 13 (15.38%)
    4 / 12 (33.33%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    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
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