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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 >=4 Years to <17 Years of Age with Partial-Onset Seizures

    Summary
    EudraCT number
    		 2012-004996-38
    Trial protocol
    		 HU   SK   BE   IT   LV   EE   CZ   ES   PL   GB   LT   BG   RO   Outside EU/EEA   SI   HR   FR  
    Global end of trial date
    24 Jan 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Apr 2018
    First version publication date
    09 Aug 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    For consistency between registries

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0969
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01921205
    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
    13 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Lacosamide (LCM) administered concomitantly with 1 to <=3 antiepileptic drugs (AEDs) in subjects with epilepsy >=4 years to <17 years of age who currently have uncontrolled partial-onset seizures.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    		 Background therapy was permitted as defined in the study protocol. Patients were treated with 1-3 concomitant antiepileptic drugs (AEDs).
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    29 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Croatia: 16
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Georgia: 29
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Latvia: 13
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Montenegro: 2
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Thailand: 33
    Country: Number of subjects enrolled
    Ukraine: 17
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    343
    EEA total number of subjects
    161
    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)
    0
    Children (2-11 years)
    182
    Adolescents (12-17 years)
    161
    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 August 2013 and concluded in January 2017.

    Pre-assignment
    Screening details
    		 The Participant Flow refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.

    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
    		 This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo - solution
    Investigational medicinal product code
    PBO - solution
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo solution matching LCM solution.

    Investigational medicinal product name
    Placebo - tablet
    Investigational medicinal product code
    PBO - tablet
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets matching LCM tablets.

    Arm title
    		 Lacosamide
    Arm description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide - solution
    Investigational medicinal product code
    LCM - solution
    Other name
    Vimpat
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    6mg/kg/day to 12 mg/kg/day determined by subject´s body weight at Baseline.

    Investigational medicinal product name
    Lacosamide - tablet
    Investigational medicinal product code
    LCM - tablet
    Other name
    Vimpat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg/day to 400mg/day determined by subject´s body weight at Baseline.

    Number of subjects in period 1
    		Placebo Lacosamide
    Started
    172
    171
    Completed
    151
    151
    Not completed
    21
    20
         Use Of Prohibited Medication
    -
    1
         Consent withdrawn by subject
    6
    5
         The Excessive Use Of Rescue Medication
    -
    1
         Non Compliance Of Child
    -
    1
         Adverse event, non-fatal
    12
    7
         Lost to follow-up
    1
    1
         Non Compliance Of The Parent
    -
    1
         Lack of efficacy
    1
    -
         Protocol deviation
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.

    Reporting group title
    Lacosamide
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

    Reporting group values
    		 Placebo Lacosamide Total
    Number of subjects
    		 172 171 343
    Age Categorical
    Units: Subjects
        <=18 years
    		 172 171 343
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.9 ± 3.5 10.5 ± 3.6 -
    Gender Categorical
    Units: Subjects
        Male
    		 99 91 190
        Female
    		 73 80 153

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.

    Reporting group title
    Lacosamide
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

    Subject analysis set title
    Placebo (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.

    Subject analysis set title
    Lacosamide (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

    Primary: Change in partial onset seizure (POS) frequency per 28 days from Baseline to the Maintenance Period

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    End point title
    		 Change in partial onset seizure (POS) frequency per 28 days from Baseline to the Maintenance Period
    End point description
    The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    168
    170
    Units: Seizures per 28 days
    median (full range (min-max))
        Median (full range)
    -1.55 (-318.7 to 690)
    -3.05 (-302.9 to 210.4)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo (FAS) v Lacosamide (FAS)
    Number of subjects included in analysis
    338
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 Percent reduction over Placebo
    Point estimate
    31.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.342
         upper limit
    		 44.277

    Secondary: Proportion of responders where a responder is defined as a participant with >= 50% reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period

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    End point title
    		 Proportion of responders where a responder is defined as a participant with >= 50% reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period
    End point description
    Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    168
    170
    Units: percentage of participants
    number (not applicable)
        Percentage of participants
    33.3
    52.9
    No statistical analyses for this end point

    Secondary: Proportion of subjects experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency per 28 days from Baseline to the end of Maintenance Period

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    End point title
    		 Proportion of subjects experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency per 28 days from Baseline to the end of Maintenance Period
    End point description
    Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    170
    170
    Units: percentage of participants
    number (not applicable)
        >=25% - <50%
    14.7
    11.8
        >=50% - <=75%
    17.1
    21.8
        >75%
    15.9
    31.2
    No statistical analyses for this end point

    Secondary: Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)

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    End point title
    		 Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)
    End point description
    The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    169
    170
    Units: Seizures per 28 days
    median (full range (min-max))
        Median (full range)
    -1.22 (-250.6 to 477)
    -2.46 (-219.2 to 210.4)
    No statistical analyses for this end point

    Secondary: Proportion of subjects experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)

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    End point title
    		 Proportion of subjects experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)
    End point description
    Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    170
    170
    Units: percentage of participants
    number (not applicable)
        >=25% - <50%
    15.3
    16.5
        >=50% - <=75%
    20.6
    20.6
        >75%
    8.8
    23.5
    No statistical analyses for this end point

    Secondary: Proportion of subjects experiencing no change in partial onset seizure frequency (between <25 % reduction and <25 % increase) per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)

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    End point title
    		 Proportion of subjects experiencing no change in partial onset seizure frequency (between <25 % reduction and <25 % increase) per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods)
    End point description
    Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    169
    170
    Units: percentage of participants
    number (not applicable)
        Percentage of participants
    32
    20.6
    No statistical analyses for this end point

    Secondary: Proportion of subjects experiencing an increase in partial onset seizure frequency per 28 days of >=25 % from Baseline to the entire treatment (ie, Titration+Maintenance Periods)

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    End point title
    		 Proportion of subjects experiencing an increase in partial onset seizure frequency per 28 days of >=25 % from Baseline to the entire treatment (ie, Titration+Maintenance Periods)
    End point description
    Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    169
    170
    Units: percentage of participants
    number (not applicable)
        Percentage of participants
    23.1
    18.8
    No statistical analyses for this end point

    Secondary: Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures

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    End point title
    		 Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures
    End point description
    The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    68
    77
    Units: Seizures per 28 days
    median (full range (min-max))
        Median (full range)
    -1.14 (-250.6 to 477)
    -1.25 (-217.4 to 100.2)
    No statistical analyses for this end point

    Secondary: Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures

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    End point title
    		 Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures
    End point description
    The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    99
    109
    Units: Seizures per 28 days
    median (full range (min-max))
        Median (full range)
    -0.98 (-78 to 239.7)
    -2.06 (-131.8 to 210.4)
    No statistical analyses for this end point

    Secondary: Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures

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    End point title
    		 Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures
    End point description
    The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16 (or last value on treatment)
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    69
    63
    Units: Seizures per 28 days
    median (full range (min-max))
        Median (full range)
    -1 (-204.7 to 39.8)
    -2.81 (-99.3 to 72.7)
    No statistical analyses for this end point

    Secondary: Proportion of seizure free days during the Maintenance Period for subjects who completed the Maintenance Period

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    End point title
    		 Proportion of seizure free days during the Maintenance Period for subjects who completed the Maintenance Period
    End point description
    The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
    End point type
    Secondary
    End point timeframe
    Week 7 to Week 16
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    154
    152
    Units: days
    arithmetic mean (standard deviation)
        Mean (standard deviation)
    0.65 ± 0.35
    0.71 ± 0.32
    No statistical analyses for this end point

    Secondary: Proportion of subjects who achieved “seizure free” status (yes/no) for subjects who completed the Maintenance Period

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    End point title
    		 Proportion of subjects who achieved “seizure free” status (yes/no) for subjects who completed the Maintenance Period
    End point description
    The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.
    End point type
    Secondary
    End point timeframe
    Week 7 to Week 16
    End point values
    		 Placebo (FAS) Lacosamide (FAS)
    Number of subjects analysed
    154
    152
    Units: percentage of participants
    number (not applicable)
        Percentage of participants
    9.7
    15.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from Visit 1 until Safety Follow-Up Visit up to week 24.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets.

    Reporting group title
    Lacosamide
    Reporting group description
    		 This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject’s body weight at Baseline (Visit 2) was used to determine the dose throughout the study.

    Serious adverse events
    		 Placebo Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 172 (7.56%)
    11 / 171 (6.43%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Postoperative respiratory distress
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    4 / 172 (2.33%)
    2 / 171 (1.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dystonia
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 172 (1.16%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 172 (0.58%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Emotional disorder of childhood
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (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
    Pneumonia
         subjects affected / exposed
    2 / 172 (1.16%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 172 (0.58%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 171 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 172 (0.58%)
    1 / 171 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Lacosamide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 172 (35.47%)
    85 / 171 (49.71%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    11 / 172 (6.40%)
    28 / 171 (16.37%)
         occurrences all number
    14
    42
    Dizziness
         subjects affected / exposed
    13 / 172 (7.56%)
    18 / 171 (10.53%)
         occurrences all number
    14
    26
    Headache
         subjects affected / exposed
    15 / 172 (8.72%)
    14 / 171 (8.19%)
         occurrences all number
    25
    19
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 172 (5.81%)
    17 / 171 (9.94%)
         occurrences all number
    11
    21
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    11 / 172 (6.40%)
    17 / 171 (9.94%)
         occurrences all number
    15
    22
    Diarrhoea
         subjects affected / exposed
    9 / 172 (5.23%)
    8 / 171 (4.68%)
         occurrences all number
    13
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 172 (5.81%)
    20 / 171 (11.70%)
         occurrences all number
    10
    29
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 172 (5.81%)
    10 / 171 (5.85%)
         occurrences all number
    14
    13
    Pharyngitis
         subjects affected / exposed
    5 / 172 (2.91%)
    10 / 171 (5.85%)
         occurrences all number
    5
    13

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2015
    The main purpose of this substantial amendment was to add details to the statistics section regarding sample size re-estimation and statistical evaluation of secondary and other efficacy variables based on the clarifications made by the South Korean Ministry of Health and align the wording with the SP0967 protocol (a double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of LCM as adjunctive therapy in subjects with epilepsy >=1 month to <4 years of age with partial-onset seizures). Based on recommendations made by the US FDA, the creatinine clearance was changed from less than 50mL/min to less than 30mL/min in Exclusion Criterion number 10. In addition, as per request from the Swedish Ministry of Health, Exclusion Criterion number 20 (excluding subjects with epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen Syndrome) was removed because it was considered to be a duplicate of Exclusion Criterion number 23 (Section 3.3.2). Exclusion Criterion number 22 was reworded to clarify that the excluded sodium channelopathies were cardiac.

    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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