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    Clinical Trial Results:
    A Multicenter, Open-Label, Randomized, Active Comparator Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

    Summary
    EudraCT number
    		 2020-001066-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Apr 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Oct 2025
    First version publication date
    29 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0968
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04519645
    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
    UCB BIOSCIENCES GmbH, Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com
    Scientific contact
    UCB BIOSCIENCES GmbH, Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000402-PIP03-17
    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
    28 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    		 -
    Evidence for comparator
    		 The local standard of care was employed as comparator.
    Actual start date of recruitment
    31 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    29
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    29
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    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 enrollment in March 2021 and concluded in October 2024. The decision to end the study prematurely was made by the Sponsor in April 2025. During Enrollment Period: 11 randomized participants started and completed Active Comparator (AC) arm and 15 randomized participants started and completed lacosamide (LCM) arm.

    Pre-assignment
    Screening details
    		 Participant Flow refers to the Safety Set (based on treatment received). For the Full Analysis Set (based on treatment assignment, 1 participant randomized to LCM received AC): 10/11 participants randomized to AC and 15/15 randomized to LCM completed the treatment period. All participants from the Treatment Period entered/completed the SFU Period.

    Period 1
    Period 1 title
    Enrollment Period (Up to 36 hours)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 No Treatment
    Arm description
    		 Participant signed the informed consent form, successfully screened and randomized but never received any study medication during the study.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Active Comparator
    Arm description
    		 Study participants randomized to receive Active Comparator (chosen and dosed based on standard of care (StOC) per local practice and treatment guidelines) in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized Active Comparator in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day Safety Follow-up (SFU) Period with optional down titration.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Lacosamide
    Arm description
    		 Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		No Treatment Active Comparator Lacosamide
    Started
    3
    12
    14
    Completed
    0
    12
    14
    Not completed
    3
    0
    0
         Adverse event, non-fatal
    1
    -
    -
         Withdrawal by Parent/Guardian
    1
    -
    -
         Protocol deviation
    1
    -
    -
    Period 2
    Period 2 title
    Treatment Period (Up to 96 hours)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Comparator
    Arm description
    		 Study participants randomized to receive Active Comparator (chosen and dosed based on StOC per local practice and treatment guidelines) in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized Active Comparator in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Comparator
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Active Comparator treatment was chosen and dosed based on StOC (per local practice and treatment guidelines).

    Arm title
    		 Lacosamide
    Arm description
    		 Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    Other name
    LCM
    Pharmaceutical forms
    Solution for infusion, Oral solution
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants received lacosamide 10 mg/mL as an intravenous (IV) infusion up to 96 hours of Treatment Period. Study participants who remain inpatient and who benefit from the LCM treatment may continue LCM if able to switch to oral LCM in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Data cannot be reported for 3 participants due to data protection/data privacy.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This is an open label study however, central readers for the EEG were blinded.
    Number of subjects in period 2 [3]
    		Active Comparator Lacosamide
    Started
    12
    14
    Safety Set (Actual Treated)
    12
    14
    Completed
    11
    14
    Not completed
    1
    0
         Consent withdrawn by parent/guardian,not due to AE
    1
    -
    Notes
    [3] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 29 participants were screened and enrolled in this study but only 26 participants were treated.
    Period 3
    Period 3 title
    Extension Period: up to 28 Days of PNA
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [4]

    Arms
    Arm title
    		 Lacosamide
    Arm description
    		 Study participants randomized to receive lacosamide 10 mg/mL 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    Other name
    LCM
    Pharmaceutical forms
    Solution for infusion, Oral solution
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants received lacosamide 10 mg/mL as an intravenous (IV) infusion up to 96 hours of Treatment Period. Study participants who remain inpatient and who benefit from the LCM treatment may continue LCM if able to switch to oral LCM in the Extension Period (up to 28 days of postnatal age). Participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Notes
    [4] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This is an open label study however, central readers for the EEG were blinded.
    Number of subjects in period 3 [5]
    		Lacosamide
    Started
    12
    Completed
    12
    Notes
    [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 15 randomized participants who completed the Treatment Period, 12 participants opted to continue in the Extension Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active Comparator
    Reporting group description
    		 Study participants randomized to receive Active Comparator (chosen and dosed based on StOC per local practice and treatment guidelines) in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized Active Comparator in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Reporting group values
    		 Active Comparator Lacosamide Total
    Number of subjects
    		 12 14 26
    Age Categorical
    Units: participants
        0-<=27 days
    		 12 14 26
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    		 3.1 ( 2.8 ) 4.1 ( 5.0 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 7 7 14
        Male
    		 5 7 12

    End points

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    End points reporting groups
    Reporting group title
    No Treatment
    Reporting group description
    		 Participant signed the informed consent form, successfully screened and randomized but never received any study medication during the study.

    Reporting group title
    Active Comparator
    Reporting group description
    		 Study participants randomized to receive Active Comparator (chosen and dosed based on standard of care (StOC) per local practice and treatment guidelines) in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized Active Comparator in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day Safety Follow-up (SFU) Period with optional down titration.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Reporting group title
    Active Comparator
    Reporting group description
    		 Study participants randomized to receive Active Comparator (chosen and dosed based on StOC per local practice and treatment guidelines) in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized Active Comparator in the Extension Period (up to 28 days of postnatal age). Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.
    Reporting group title
    Lacosamide
    Reporting group description
    		 Study participants randomized to receive lacosamide 10 mg/mL 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours in the Treatment Period. After the Treatment Period, study participants had the option to continue to receive randomized lacosamide in the Extension Period (up to 28 days of postnatal age), being switched to oral dosing of lacosamide as soon as medically possible. Study participants (whether they discontinued randomized treatment during the Treatment Period, completed the Extension Period, were discharged from the hospital, or reached 28 days of postnatal age) then entered the 14-day SFU Period with optional down titration.

    Subject analysis set title
    Lacosamide
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Study participants randomized to receive lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours. The dose of LCM could be reduced based on clinical judgement of the investigator after the first dose Study participants who remain inpatient and who benefit from the LCM treatment may continue LCM if able to switch to oral LCM in the Extension Period. One participant was randomized to lacosamide but actually received Active Comparator. Therefore, based on randomization assignment, 15 participants are in the LCM arm in the full analysis set.

    Primary: Change in Seizure Burden Measured in the Evaluation Video-electroencephalogram (video-EEG) Compared with the Baseline Video-EEG

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    End point title
    		 Change in Seizure Burden Measured in the Evaluation Video-electroencephalogram (video-EEG) Compared with the Baseline Video-EEG [1]
    End point description
    Baseline seizure burden=seizure burden measured on continuous video-EEG (total electroencephalographic neonatal seizures (ENS) in minutes per hour) during period of up to 2 hours immediately prior to 1st administration of study drug. ENS= EEG seizure lasting for at least 10 seconds on video-EEG. Seizure burden in Evaluation Period= total duration of seizures between 1 and 3 hours after 1st dose of study medication divided by duration of interpretable video-EEG available in same period. Change in seizure burden measured in Evaluation video-EEG compared with Baseline video-EEG was analyzed such that positive value= reduction in seizure burden from baseline. Full Analysis Set (FAS) consisted of all study participants in SS who had minimum of 30 minutes of interpretable video-EEG data from both Baseline and period between 1 and 3 hours (Evaluation Period) after randomization to initial study medication treatment."N"= participants evaluable for this assessment. FAS=randomized treatment.
    End point type
    Primary
    End point timeframe
    During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
    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 as descriptive statistics only.
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    11
    Units: minute per hour (min/hour)
        arithmetic mean (standard deviation)
    2.45 ( 14.83 )
    6.64 ( 6.55 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With at least 80% Reduction in Seizure Burden in the Evaluation a Video-EEG Compared with the Baseline Video-EEG

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    End point title
    		 Percentage of Participants With at least 80% Reduction in Seizure Burden in the Evaluation a Video-EEG Compared with the Baseline Video-EEG [2]
    End point description
    A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to investigational medicinal product (IMP) administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: A reduction in seizure burden from Baseline of >=80% regardless of baseline seizure severity. Percentage of Participants With at least 80% Reduction in Seizure Burden in the Evaluation (starting 1 hour after treatment) of a Video-EEG Compared with the Baseline Video-EEG were reported. The FAS was used, and the population was based on randomized treatment.
    End point type
    Secondary
    End point timeframe
    During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    15
    Units: percentage of participants
        number (not applicable)
    44.4
    60.0
    No statistical analyses for this end point

    Secondary: Time to Response Across the 48-hour Treatment Period Compared with the Baseline Video-EEG

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    End point title
    		 Time to Response Across the 48-hour Treatment Period Compared with the Baseline Video-EEG [3]
    End point description
    Time to response where response was defined as a reduction in seizure burden from Baseline of at least 80% in participants with non-severe seizure burden, and of at least 50% for participants with severe seizure burden. Time to response was censored at the date/time the participant received rescue medication or stopped video-EEG monitoring, or otherwise at the end of the 48-hour period. The FAS was used, and population was based on randomized treatment. Here, 99999 and -99999 refers to upper and lower limits of 95% confidence interval could not be calculated by the Kaplan-Meier model due to heavy censoring occurring before the median survival time was observed and a lack of variability in the response times (9/10 patients reported the same time to response).
    End point type
    Secondary
    End point timeframe
    Across the first 48 hours of Treatment Period, compared to Baseline
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    15
    Units: hours
        median (confidence interval 95%)
    3.0 (3.0 to 8.0)
    3.0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Responders in the Evaluation Video-EEG Compared with the Baseline Video-EEG

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    End point title
    		 Percentage of Responders in the Evaluation Video-EEG Compared with the Baseline Video-EEG [4]
    End point description
    A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to the study medication administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: − At least 80% reduction of seizure burden in participants who were categorized by the Investigator as having non-severe seizure burden during Baseline OR − At least 50% reduction of seizure burden in participants who were categorized by the Investigator as having severe seizure burden during Baseline. The FAS was used, and population was based on randomized treatment.
    End point type
    Secondary
    End point timeframe
    During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    15
    Units: percentage of participants
        number (not applicable)
    66.7
    60.0
    No statistical analyses for this end point

    Secondary: Absolute Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared With the Baseline Video-EEG

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    End point title
    		 Absolute Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared With the Baseline Video-EEG
    End point description
    Baseline seizure burden=total duration of seizures (in minutes) between -2 and 0 hours before first dose of study medication divided by total duration of interpretable video-EEG(in hours) in same period. Seizure burden for 8,16,24,32,40 and 48 hour time points= total duration of seizures in hour prior to time point divided by duration of interpretable video-EEG available in same period. If <30 minutes of interpretable video-EEG were available in 1 hour prior to time point, response=seizure burden for most recent 30 minutes of interpretable video-EEG in 2 hours(8 and 16 hour points)or 4 hours(24, 32, 40 and 48 hour points)prior to time point. 30 minutes of video-EEG did not need to be continuous.Absolute reduction in seizure burden for these time points=seizure burden in Baseline Period minus seizure burden at that time point. FAS was used, and population was based on randomized treatment."N"= participants evaluable for this assessment;n=participants evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Treatment Period: 7-8 hours, 15-16 hours, 23-24 hours, 31-32 hours, 39-40 hours, 47-48 hours, compared to Baseline
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    6
    11
    Units: mins/hour
    arithmetic mean (standard deviation)
        Treatment, 7 hour - 8 hour (n=6,11)
    -2.74 ( 15.53 )
    6.30 ( 6.74 )
        Treatment, 15 hour - 16 hour (n=6,10)
    3.63 ( 5.28 )
    7.21 ( 6.33 )
        Treatment, 23 hour - 24 hour (n=6,10)
    5.08 ( 4.81 )
    8.69 ( 8.06 )
        Treatment, 31 hour - 32 hour (n=5, 10)
    5.71 ( 5.09 )
    8.93 ( 8.56 )
        Treatment, 39 hour - 40 hour (n=4, 10)
    4.43 ( 5.80 )
    8.93 ( 8.56 )
        Treatment, 47 hour - 48 hour (n=4,10)
    4.84 ( 5.44 )
    8.93 ( 8.56 )
    No statistical analyses for this end point

    Secondary: Time to Seizure Freedom Across the First 48-hour Treatment Period Compared with the Baseline Video-EEG

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    End point title
    		 Time to Seizure Freedom Across the First 48-hour Treatment Period Compared with the Baseline Video-EEG [5]
    End point description
    Seizure freedom was defined as 0 minutes of seizures in a 1-hour period (or 2-hour period for the 3-hour time point) and was analyzed across the 48 hours. The time to seizure freedom was measured in hours, defined as the first time point when the response criterion was met minus the date and time of the first dose of randomized study medication administration. Time to seizure freedom was censored at the time of receiving rescue medication, stopping video-EEG monitoring or otherwise at 48 hours after first dose. The FAS was used, and population was based on randomized treatment. Here, 99999 and -99999 refers to upper and lower limits of 95% confidence interval could not be calculated by the Kaplan-Meier model due to heavy censoring occurring before the median survival time was observed and a lack of variability in the response times (4/6 participants [Active Comparator] and 9/10 participants [Lacosamide]) reported the same time to seizure freedom).
    End point type
    Secondary
    End point timeframe
    Across the first 48 hours of Treatment Period, compared to Baseline
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    15
    Units: hours
        median (confidence interval 95%)
    8.0 (3.0 to 99999)
    3.0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percent Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared with the Baseline Video-EEG

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    End point title
    		 Percent Change in Seizure Burden Across the First 48-hours of the Treatment Period Measured by Continuous Video-EEG Compared with the Baseline Video-EEG
    End point description
    The percent change in seizure burden for the 8, 16, 24, 32, 40 and 48 hour time points was calculated as the seizure burden at Baseline minus the seizure burden at the respective time point, divided by the seizure burden in the Baseline Period, multiplied by 100. Percent change in seizure burden was analyzed such that a positive value indicates a reduction in seizure burden from baseline. FAS was used, and population was based on randomized treatment. Here, "N" included all participants who were evaluable for this assessment and n signifies participants who were evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Treatment Period: 7-8 hours, 15-16 hours, 23-24 hours, 31-32 hours, 39-40 hours, 47-48 hours, compared to Baseline
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    6
    11
    Units: percent change
    arithmetic mean (standard deviation)
        Treatment: 7 hour-8 hour (n=6,11)
    39.85 ( 147.33 )
    80.92 ( 45.56 )
        Treatment: 15 hour-16 hour (n=6,10)
    48.22 ( 116.94 )
    93.19 ( 21.53 )
        Treatment: 23 hour-24 hour (n=6,10)
    100.00 ( 0.00 )
    99.03 ( 3.05 )
        Treatment: 31 hour-32 hour (n=5,10)
    100.00 ( 0.00 )
    100.00 ( 0.00 )
        Treatment: 39 hour-40 hour (n=4,10)
    77.13 ( 45.73 )
    100.00 ( 0.00 )
        Treatment: 47 hour-48 hour (n=4,10)
    100.00 ( 0.00 )
    100.00 ( 0.00 )
    No statistical analyses for this end point

    Secondary: Categorized Percentage of Participants With Change in Seizure Burden in the Evaluation Video-EEG Compared With the Baseline Video-EEG

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    End point title
    		 Categorized Percentage of Participants With Change in Seizure Burden in the Evaluation Video-EEG Compared With the Baseline Video-EEG
    End point description
    Baseline seizure burden=total duration of seizures(in mins)between -2 and 0 hours before 1st dose of study medication divided by total duration of interpretable video-EEG(in hours)in same period.Seizure burden in Evaluation Period=total duration of seizures between 1 and 3 hours after 1st dose of study medication divided by duration of interpretable video-EEG available in same period.Percent(%) change in seizure burden for Evaluation period=seizure burden at Baseline minus seizure burden at time points,divided by seizure burden in Baseline Period, multiplied by 100.Participants classified in categories based on their %reduction from Baseline to Evaluation Period: <-25%(worsening),-25%- <25%(no change),25%-<50%,50%-<80%, >=80%.% change in seizure burden was analyzed and categorized as positive value=reduction in seizure burden from baseline.FAS was used, population based on randomized treatment."N"=participants evaluable for assessment.
    End point type
    Secondary
    End point timeframe
    During 2-hour Evaluation starting 1 hour after initial treatment (up to 2 hours), compared to Baseline
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    9
    11
    Units: Percentage of participants
    number (not applicable)
        Evaluation:1 hour-3 hour: <-25
    22.2
    0.0
        Evaluation: 1 hour-3 hour: -25% to <25%
    0.0
    9.1
        Evaluation: 1 hour-3 hour: 25% to <50%
    11.1
    9.1
        Evaluation: 1 hour-3 hour: 50% to <80%
    22.2
    0.0
        Evaluation: 1 hour-3 hour: >=80%
    44.4
    81.8
    No statistical analyses for this end point

    Secondary: Percentage of Responders at the end of the First 48-hours of the Treatment Period

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    End point title
    		 Percentage of Responders at the end of the First 48-hours of the Treatment Period
    End point description
    A responder is defined as a study participant who achieved the following reduction in seizure burden without need for rescue medication, compared with the seizure burden measured during the Baseline Period immediately prior to investigational medicinal product (IMP) administration, evaluated for a 2-hour period starting 1 hour after the start of initial treatment: At least 80% reduction of seizure burden in participants who were categorized as having nonsevere seizure burden during Baseline OR At least 50% reduction of seizure burden in participants who had at least one 30-minute period of severe seizure burden during Baseline. The denominator for the percentages was based on the number of participants with video- EEG data available at the 48 hour time point. FAS was used, and population was based on randomized treatment. Here, "N" included all participants who were evaluable for this assessment.
    End point type
    Secondary
    End point timeframe
    Across the first 48 hours of Treatment Period
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    6
    13
    Units: percentage of participants
        number (not applicable)
    66.7
    76.9
    No statistical analyses for this end point

    Secondary: Percentage of Study Participants who are Seizure-free (100% Reduction in Seizure Burden from Baseline) at 24 hours After Start of the Treatment Period, Categorized by Study Participants with Non severe or Severe Seizure Burden at Baseline

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    End point title
    		 Percentage of Study Participants who are Seizure-free (100% Reduction in Seizure Burden from Baseline) at 24 hours After Start of the Treatment Period, Categorized by Study Participants with Non severe or Severe Seizure Burden at Baseline
    End point description
    Seizure free was defined as 100% reduction in seizure burden or having no seizures in the assessment period (23 to 24 hours after first dose) from Baseline. For the study participants with severe seizure burden at Baseline (as determined by the Investigator), the numerator was defined as the number of participants with severe seizure burden at Baseline who had no seizures between 23 and 24 hours after the start of the Treatment Period. The denominator for the percentages was based on the number of participants with video-EEG data available at the 24 hour time point. FAS was used and population was based on randomized treatment. Here, "N" included all participants who were evaluable for this assessment and "n"= participants evaluable for specified seizure burden categories.
    End point type
    Secondary
    End point timeframe
    24 hours after the start of Treatment Period, compared to Baseline
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    8
    14
    Units: percentage of participants
    number (not applicable)
        Severe Seizure Burden (n=3,6)
    33.3
    66.7
        Non-severe Seizure Burden (n=5,8)
    100.0
    62.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-emergent Marked Abnormalities in 12-lead Electrocardiogram (ECG)

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    End point title
    		 Percentage of Participants with Treatment-emergent Marked Abnormalities in 12-lead Electrocardiogram (ECG)
    End point description
    The ECG treatment-emergent marked abnormalities values are based on grade 2 toxicity based on abnormal values or clinical experience based on investigator's discretion. Participants randomized to Lacosamide and enrolled under this version of the protocol have planned assessments at Screening, 1-6 hours, 48, and 96 hours only. For participants randomized to Active Comparator treatment, only the Screening assessment was applicable. The SS consisted of all enrolled study participants who took at least 1 dose of the randomized treatment. The safety population was based on actual treatment. Here, "N" included all participants with a non-missing interpretation for this assessment.
    End point type
    Secondary
    End point timeframe
    Active Comparator: Screening; Lacosamide: Screening, 1-6 hours, 48 and 96 hours
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    8
    7
    Units: percentage of participants
    number (not applicable)
        Screening:Abnormal Clinically significant(n=8,14)
    0.0
    0.0
        1-6 hours:Abnormal Clinically significant(n=0,9)
    0
    0.0
        48 hours:Abnormal Clinically significant(n=0,13)
    0
    0.0
        96 hours:Abnormal Clinically significant(n=0,12)
    0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) as Reported by the Investigator

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    End point title
    		 Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) as Reported by the Investigator
    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. TEAEs are defined as AEs which have onset on or after the start date and time of initial study medication administration. The SS consisted of all enrolled study participants who took at least 1 dose of the randomized treatment. The safety population was based on actual treatment.
    End point type
    Secondary
    End point timeframe
    From first administration of study treatment to the End of Safety Follow-up Period (up to Day 42)
    End point values
    		 Active Comparator Lacosamide
    Number of subjects analysed
    12
    14
    Units: percentage of participants
        number (not applicable)
    41.7
    64.3
    No statistical analyses for this end point

    Secondary: Serum Concentration of Lacosamide

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    End point title
    		 Serum Concentration of Lacosamide [6]
    End point description
    Serum concentrations of lacosamide were measured and concentration data were summarized. PK sparse sampling was performed. The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all study participants who provide at least 1 measurable serum sample (with recorded sampling time) on at least 1 post-Baseline visit with documented study drug intake times. Here, overall number of participants analyzed "N" included all participants who were evaluable for this assessment, number analyzed (n) signifies participants who were evaluable at specified timepoints and 99999 refers to Geometric mean and Geometric Coefficient of Variation could not be calculated due to less number of participants.
    End point type
    Secondary
    End point timeframe
    Day 1: 30-90 minutes and 6 - 8 hours after start of first infusion, 30 - 90 minutes and 6 - 8 hours after start of second or third infusion, Days 2, 3 and 4
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    		 Lacosamide
    Number of subjects analysed
    13
    Units: microgram per milliliter (mcg/mL)
    geometric mean (geometric coefficient of variation)
        Day 1:30-90 mins after 1st infusion(n=11)
    7.003 ( 37.6 )
        Day 1:6-8 hours after 1st infusion(n=12)
    5.949 ( 38.6 )
        Day 1: 30–90 min after 2nd/3rd infusion (n=11)
    13.27 ( 29.4 )
        Day 1:6-8 hours after 2nd/ 3rd infusion(n=13)
    9.607 ( 39.8 )
        Day 2 (n=1)
    99999 ( 99999 )
        Day 3 (n=2)
    99999 ( 99999 )
        Day 4 (n=2)
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Enrolment: Screening (-36 hours) up to 0 hours (pre-dose); Treatment: From first administration of study treatment to the End of Safety Follow-up (up to Day 42)
    Adverse event reporting additional description
    TEAEs are defined as AEs which had onset on or after the start date and time of initial study medication administration. SS was used. Eligible participants who did not undergo any treatment of lacosamide but experienced an AE, are presented in a separate group "No Treatment".
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    No Treatment
    Reporting group description
    		 Participant signed the informed consent form, successfully screened and randomized but never received any study medication during the study.

    Reporting group title
    Lacosamide
    Reporting group description
    		 Participants received lacosamide 10 milligram per milliliter (mg/mL) 3 times a day as an intravenous infusion over 30 minutes for up to 96 hours. The dose of LCM could be reduced based on clinical judgement of the investigator after the first dose.

    Reporting group title
    Active Comparator
    Reporting group description
    		 Study participants randomized to receive Active Comparator chosen based on standard of care (StOC) (per local practice and treatment guidelines) in the Clinical Practice in the Treatment Period.

    Serious adverse events
    		 No Treatment Lacosamide Active Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Congenital, familial and genetic disorders
    Congenital central nervous system anomaly
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 No Treatment Lacosamide Active Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    8 / 14 (57.14%)
    5 / 12 (41.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercapnia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Elevated Alanine Aminotransferase
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Right ventricular hypertrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Reflexes abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Poor sucking reflex
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Convulsion
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Depressed level of consciousness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Intracranial pressure increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Retinal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    1
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Cholestasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Diabetes insipidus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Adrenal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Adrenal insufficiency
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Neonatal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Feeding disorder neonatal
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2020
    Protocol Amendment 1 was dated 13 Oct 2022. The purpose of this substantial amendment was changes to the protocol have been made to simplify the study logistics, to update secondary objectives, to provide updated data from the pediatric PK model, and to improve consistency within the protocol. Minor grammatical, editorial, and formatting changes have also been made for clarification purposes only.
    11 Feb 2022
    Protocol Amendment 2 was dated 11 Feb 2022. The purpose of this substantial amendment was to change the protocol and made it align to the study more closely with the Neonatal Intensive Care Unit’s (NICU) standard of care and practice, clarify the age criterion, clarify the Schedule of Activities, align with the current Statistical Analysis Plan (SAP), and align with the current lacosamide (LCM) clinical development program. Minor grammatical, editorial, and formatting changes have also been made for clarification purposes only.

    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.
    The study ended prematurely after agreed PIP modification; termination was not linked to any safety issues/reasons.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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