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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy >=1 Month to <4 Years of Age With Partial-Onset Seizures

    Summary
    EudraCT number
    		 2013-000717-20
    Trial protocol
    		 HU   GB   CZ   LT   IT   DE   ES   FR   PL   RO   GR   BG   HR   SK   BE   PT   DK   FI   Outside EU/EEA  
    Global end of trial date
    28 May 2020

    Results information
    Results version number
    		 v1
    This version publication date
    04 Dec 2020
    First version publication date
    04 Dec 2020
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0967
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02477839
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES Inc.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, NC 27617
    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
    12 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to 3 AEDs in subjects ≥1 month to <4 years of age with epilepsy who currently have uncontrolled partial-onset seizures.
    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
    05 Jun 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    China: 14
    Country: Number of subjects enrolled
    Croatia: 5
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Georgia: 21
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hungary: 26
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Lithuania: 2
    Country: Number of subjects enrolled
    Mexico: 29
    Country: Number of subjects enrolled
    Moldova, Republic of: 2
    Country: Number of subjects enrolled
    Philippines: 2
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    Serbia: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Ukraine: 64
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    255
    EEA total number of subjects
    61
    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)
    121
    Children (2-11 years)
    134
    Adolescents (12-17 years)
    0
    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 patients in June 2015 and concluded in May 2020.

    Pre-assignment
    Screening details
    		 Completed study was defined as participants who had “Completed study participant” selected as status at termination. The total number of participants who completed the study comprises of those who completed the Transition Period and the ones that completed the Taper Period after completing the Maintenance Period. Participant Flow refers to the SS.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo syrup.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo syrup. Placebo was measured and administered via a dosing syringe. If a study participant was unable to swallow the oral solution, administration by feeding tube was permitted.

    Arm title
    		 Lacosamide
    Arm description
    		 Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    LCM
    Other name
    Vimpat
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day. LCM was measured and administered via a dosing syringe. If a study participant was unable to swallow the oral solution, administration by feeding tube was permitted.

    Number of subjects in period 1
    		Placebo Lacosamide
    Started
    127
    128
    Completed Transition Period
    124
    117 [1]
    Completed Taper after Maintenance
    0 [2]
    1 [3]
    Completed
    124
    118
    Not completed
    3
    10
         Consent withdrawn by subject
    3
    3
         Adverse event, non-fatal
    -
    1
         Exclusion criterion
    -
    1
         Lack of tolerability
    -
    1
         Parents decided to stop medication
    -
    1
         Participant had PGS during V6
    -
    1
         Protocol deviation
    -
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who completed the Transition Period.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who completed the Taper Period after completing the Maintenance Period.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of participants at the milestones reflects those who completed the Taper Period after completing the Maintenance Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo syrup.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.

    Reporting group values
    		 Placebo Lacosamide Total
    Number of subjects
    		 127 128 255
    Age categorical
    Units: Subjects
        <=18 years
    		 127 128 255
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 26.1 ± 13.4 25.2 ± 13.6 -
    Gender categorical
    Units: Subjects
        Male
    		 75 71 146
        Female
    		 52 57 109

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo syrup.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day.

    Subject analysis set title
    Placebo (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received matching placebo syrup, forming the Safety Set (SS).

    Subject analysis set title
    Lacosamide (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received matching placebo syrup, forming the Full Analysis Set (FAS).

    Subject analysis set title
    Lacosamide (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the FAS.

    Primary: Percentage of participants with >= 50% reduction in partial-onset seizure frequency from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants with >= 50% reduction in partial-onset seizure frequency from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    A responder was a study participant experiencing a 50% or greater reduction in average daily frequency (ADF) of electrographic partial-onset seizures (POS) recorded on the End-of-Maintenance (EOM) Period video-electroencephalogram (EEG) compared to the End-of-Baseline (EOB) Period video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Primary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    127
    128
    Units: percentage of participants
        number (not applicable)
    37.5
    41.4
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Odds ratio (LCM/PBO), 95% CI, and p-value were from a logistic regression model with factors for treatment, pooled randomized age stratum, and pooled center.
    Comparison groups
    Lacosamide (FAS) v Placebo (FAS)
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5809
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.163
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.991

    Primary: Participant withdrawals due to adverse events (AEs) during the study

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    End point title
    		 Participant withdrawals due to adverse events (AEs) during the study [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
    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 outcome. Results were summarized as descriptive statistics only.
    End point values
    		 Placebo (SS) Lacosamide (SS)
    Number of subjects analysed
    127
    128
    Units: percentage of participants
        number (not applicable)
    0
    1.6
    No statistical analyses for this end point

    Primary: Percentage of participants with adverse events reported spontaneously by the participant's parent(s) and/or legal representative(s)/caregiver(s) (in accordance with local regulation) or observed by the investigator

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    End point title
    		 Percentage of participants with adverse events reported spontaneously by the participant's parent(s) and/or legal representative(s)/caregiver(s) (in accordance with local regulation) or observed by the investigator [2]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. The Safety Set (SS) included all randomized study participants who took at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    From the Baseline Period (Day -7) to the End of Study Visit (up to 93 days)
    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 outcome. Results were summarized as descriptive statistics only.
    End point values
    		 Placebo (SS) Lacosamide (SS)
    Number of subjects analysed
    127
    128
    Units: percentage of participants
        number (not applicable)
    59.1
    56.3
    No statistical analyses for this end point

    Secondary: Absolute change in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Absolute change in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    The absolute change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    123
    121
    Units: absolute change
        arithmetic mean (standard deviation)
    -4.7650 ± 18.0115
    -2.9427 ± 7.4938
    No statistical analyses for this end point

    Secondary: Percent change in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percent change in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    The percent change in ADF of electrographic partial-onset seizures as measured on the End-of-Maintenance Period video-EEG compared to the End-of-Baseline Period video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). The analysis consisted of all study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    122
    121
    Units: percent change
        arithmetic mean (standard deviation)
    -26.7927 ± 58.5564
    -32.3564 ± 65.0255
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved 'seizure-free' status from all seizure types during the End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants who achieved 'seizure-free' status from all seizure types during the End-of-Maintenance (EOM) Period video-EEG
    End point description
    A study participant was considered seizure-free from all seizures if the End-of-Maintenance (EOM) Period video-EEG had zero seizures reported from all seizure types (not just partial-onset seizures (POS)). Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    During the End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    117
    Units: percentage of participants
        number (not applicable)
    15.8
    17.1
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved 'seizure-free' status from partial-onset seizure types only during the End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants who achieved 'seizure-free' status from partial-onset seizure types only during the End-of-Maintenance (EOM) Period video-EEG
    End point description
    A study participant was considered seizure free from partial-onset seizures (POS) if the End-of-Maintenance (EOM) Period video-EEG had zero POS reported. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who completed at least 48 hours of interpretable video-EEG recordings during the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    During the End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    117
    Units: percentage of participants
        number (not applicable)
    16.7
    18.8
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing a >=25% to <50% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants experiencing a >=25% to <50% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    A ≥25% to <50% response was defined as ≥25% to <50% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    116
    Units: percentage of participants
        number (not applicable)
    18.3
    18.1
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing a 50% to 75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants experiencing a 50% to 75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    A ≥50% to ≤75% response was defined as ≥50% to ≤75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    116
    Units: percentage of participants
        number (not applicable)
    17.5
    10.3
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing a >75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants experiencing a >75% reduction in average daily frequency (ADF) of electrographic partial-onset seizures from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    A >75% response was defined as >75% reduction in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    116
    Units: percentage of participants
        number (not applicable)
    20.0
    31.0
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing no change in average daily frequency (ADF) of electrographic partial-onset seizures (between <25% reduction and <25% increase) from EOB Period video-EEG to EOM Period video-EEG

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    End point title
    		 Percentage of participants experiencing no change in average daily frequency (ADF) of electrographic partial-onset seizures (between <25% reduction and <25% increase) from EOB Period video-EEG to EOM Period video-EEG
    End point description
    No change was defined as between <25% reduction and <25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    116
    Units: percentage of participants
        number (not applicable)
    28.3
    27.6
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing an increase in average daily frequency (ADF) of electrographic partial-onset seizures of >=25% from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG

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    End point title
    		 Percentage of participants experiencing an increase in average daily frequency (ADF) of electrographic partial-onset seizures of >=25% from End-of-Baseline (EOB) Period video-EEG to End-of-Maintenance (EOM) Period video-EEG
    End point description
    An increase was defined as ≥25% increase in ADF of electrographic partial-onset seizures (POS) from the End-of-Baseline (EOB) video-EEG to the End-of-Maintenance (EOM) video-EEG. Full Analysis Set (FAS) included all study participants in the Safety Set (SS). Percentages were based on the number of study participants in the FAS who had at least 48 hours of interpretable recordings during the EOB Period video-EEG and the EOM Period video-EEG.
    End point type
    Secondary
    End point timeframe
    End-of-Baseline Period (Day -3 to Day 1) to End-of-Maintenance Period (Day 24 to Day 27)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    120
    116
    Units: percentage of participants
        number (not applicable)
    15.0
    12.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from the Titration Period (Day 1) to the End of Study Visit (up to 86 days)
    Adverse event reporting additional description
    Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the date of first study medication administration and within 30 days following the date of final study medication administration, or whose severity worsens within this time frame.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo (SS)
    Reporting group description
    		 Participants received matching placebo syrup, forming the Safety Set (SS).

    Reporting group title
    Lacosamide (SS)
    Reporting group description
    		 Participants received lacosamide (LCM) syrup 8 mg/kg/day to 12 mg/kg/day, forming the SS.

    Serious adverse events
    		 Placebo (SS) Lacosamide (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 127 (4.72%)
    6 / 128 (4.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 127 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (SS) Lacosamide (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 127 (23.62%)
    31 / 128 (24.22%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    5 / 127 (3.94%)
    18 / 128 (14.06%)
         occurrences all number
    6
    22
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    15 / 127 (11.81%)
    7 / 128 (5.47%)
         occurrences all number
    20
    9
    Irritability
         subjects affected / exposed
    6 / 127 (4.72%)
    7 / 128 (5.47%)
         occurrences all number
    6
    7
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 127 (10.24%)
    6 / 128 (4.69%)
         occurrences all number
    14
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2015
    The primary purposes of Protocol Amendment 1 (dated 14 Jan 2015) were to implement the contingent primary efficacy variable for the US, to include sensitivity analyses for the primary endpoint, to clarify the enrollment of study participants <2 years of age, and to provide additional detail regarding the sample size re-estimation at the request of the US Food and Drug Administration (FDA). The following changes were made throughout the protocol: • Contact details for the Clinical Project Manager were updated. • The Sponsor Declaration was updated for electronic signature. • The language of the percentage of study participants <2 years of age to be included in the study was clarified. • The contingent primary efficacy variable for the US was defined. • The anticipated serious adverse event (SAE) table was updated to include a footnote for convulsion. • Text for adherence to the protocol was updated. • Text for healthcare resource use was updated. • A rescue medication assessment was added. • Analysis of the primary efficacy variable for the US and EU was updated. • The sensitivity analysis was described. • Sample size re-estimation text was further detailed.
    09 Aug 2016
    The primary purposes of Protocol Amendment 2 (dated 09 Aug 2016) were as follows: • Elements of the study design were clarified, including inclusion and exclusion criteria, withdrawal criteria, permitted and prohibited concomitant medication, and study procedures to make the protocol more patient-friendly and to enhance enrollment. • The protocol was updated per the new UCB protocol template (eg, added text regarding potential drug-induced liver injury [PDILI]).
    05 Apr 2018
    The primary purpose of Protocol Amendment 3 (dated 05 Apr 2018) was to address the high variability in video-electroencephalogram (EEG) seizure counts between the site and central reader by removing the central reader. This change was proposed by the FDA as part of a Type C meeting written response obtained on 25 Jan 2018. Additional changes in Protocol Amendment 3 included the following: • Contact information for the clinical trial biostatistician was updated. • The regulatory status of LCM in the US and EU was updated. • The planned number of study participants per age group to reflect UCB’s commitment to make every attempt to enroll study participants <2 years of age while recognizing the difficulty of enrolling this age group was clarified. • Ineligibility of an otherwise eligible study participant who had undergone the Baseline EEG due to the narrow visit window for central laboratory measurements was prevented. • It was clarified that “seizure-free” status during the Maintenance Period would be summarized by (1) all seizure types and (2) POS types only. • Hematology and chemistry measurements for the assessment of PDILI events were updated. • The Markov chain Monte Carlo multiple imputation method was replaced with a more appropriate monotone regression method. • An age group was added to the analysis of the primary efficacy variable since randomization was stratified by age group.

    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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