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    Clinical Trial Results:
    A MULTI-CENTER, OPEN-LABEL, EXPLORATORY STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS >=1 MONTH TO <18 YEARS WITH EPILEPSY SYNDROMES ASSOCIATED WITH GENERALIZED SEIZURES

    Summary
    EudraCT number
    2012-001446-18
    Trial protocol
    DE   HU   PL   Outside EU/EEA   FR  
    Global end of trial date
    10 Apr 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Oct 2018
    First version publication date
    25 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0966
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01969851
    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)
    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
    25 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and tolerability of lacosamide (LCM) when added to 1 to 3 concomitant antiepileptic drugs (AEDs) in pediatric subjects with epilepsy syndromes associated with generalized seizures • To obtain preliminary efficacy data of LCM on seizure frequency in pediatric epilepsy syndromes associated with generalized seizures • An additional objective is to evaluate the pharmacokinetic (PK) of LCM in subjects >=1 month to <18 years of age
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    13 Feb 2014
    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
    France: 3
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    55
    EEA total number of subjects
    28
    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)
    3
    Children (2-11 years)
    31
    Adolescents (12-17 years)
    21
    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 February 2014 and concluded in April 2018.

    Pre-assignment
    Screening details
    The Participant Flow refers to the Safety Set which consisted of all enrolled subjects who took at least 1 dose of lacosamide (LCM).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Lacosamide 1 month - <4 years
    Arm description
    Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide oral solution
    Investigational medicinal product code
    LCM oral solution
    Other name
    Vimpat oral solution
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The formulation of LCM to be administered is based on the weight of the subject. Subjects weighing <50 kg or those >=50 kg who are unable or unwilling to swallow tablets were dispensed LCM oral solution. Treatment was initiated with LCM oral solution at 2 mg/kg/day for subjects weighing <50 kg, or 100 mg/day in subjects weighing >=50 kg. The dose was titrated in a stepwise fashion on a weekly basis to optimize tolerability and seizure control, not to exceed 12 mg/kg/day (oral solution) for subjects weighing <50 kg. At the end of the Titration Period (Visit 6), a 12 week Maintenance Period began. Subjects had to titrate to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg in order to enter the Maintenance Period. The LCM dose remained stable throughout the Maintenance Period. Subjects who required a change in dose during the Maintenance Period were withdrawn from the study.

    Arm title
    Lacosamide 4 years - <12 years
    Arm description
    Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide oral solution
    Investigational medicinal product code
    LCM oral solution
    Other name
    Vimpat oral solution
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The formulation of LCM to be administered is based on the weight of the subject. Subjects weighing <50 kg or those >=50 kg who are unable or unwilling to swallow tablets were dispensed LCM oral solution. Treatment was initiated with LCM oral solution at 2 mg/kg/day for subjects weighing <50 kg, or 100 mg/day in subjects weighing >=50 kg. The dose was titrated in a stepwise fashion on a weekly basis to optimize tolerability and seizure control, not to exceed 12 mg/kg/day (oral solution) for subjects weighing <50 kg. At the end of the Titration Period (Visit 6), a 12 week Maintenance Period began. Subjects had to titrate to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg in order to enter the Maintenance Period. The LCM dose remained stable throughout the Maintenance Period. Subjects who required a change in dose during the Maintenance Period were withdrawn from the study.

    Investigational medicinal product name
    Lacosamide tablet
    Investigational medicinal product code
    LCM tablet
    Other name
    Vimpat tablet
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The formulation of LCM to be administered is based on the weight of the subject. Only subjects weighing >=50 kg who are able and willing to swallow tablets were dispensed LCM tablets. Treatment was initiated with LCM tablets at 100 mg/day. The dose was titrated in a stepwise fashion on a weekly basis to optimize tolerability and seizure control, not to exceed 600 mg/day in subjects weighing >=50 kg. At the end of the Titration Period (Visit 6), a 12 week Maintenance Period began. Subjects had to titrate to at least 200 mg/day for subjects weighing >=50 kg in order to enter the Maintenance Period. The LCM dose remained stable throughout the Maintenance Period. Subjects who required a change in dose during the Maintenance Period were withdrawn from the study.

    Arm title
    Lacosamide 12 years - <18 years
    Arm description
    Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide oral solution
    Investigational medicinal product code
    LCM oral solution
    Other name
    Vimpat oral solution
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    The formulation of LCM to be administered is based on the weight of the subject. Subjects weighing <50 kg or those >=50 kg who are unable or unwilling to swallow tablets were dispensed LCM oral solution. Treatment was initiated with LCM oral solution at 2 mg/kg/day for subjects weighing <50 kg, or 100 mg/day in subjects weighing >=50 kg. The dose was titrated in a stepwise fashion on a weekly basis to optimize tolerability and seizure control, not to exceed 12 mg/kg/day (oral solution) for subjects weighing <50 kg. At the end of the Titration Period (Visit 6), a 12 week Maintenance Period began. Subjects had to titrate to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg in order to enter the Maintenance Period. The LCM dose remained stable throughout the Maintenance Period. Subjects who required a change in dose during the Maintenance Period were withdrawn from the study.

    Investigational medicinal product name
    Lacosamide tablet
    Investigational medicinal product code
    LCM tablet
    Other name
    Vimpat tablet
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The formulation of LCM to be administered is based on the weight of the subject. Only subjects weighing >=50 kg who are able and willing to swallow tablets were dispensed LCM tablets. Treatment was initiated with LCM tablets at 100 mg/day. The dose was titrated in a stepwise fashion on a weekly basis to optimize tolerability and seizure control, not to exceed 600 mg/day in subjects weighing >=50 kg. At the end of the Titration Period (Visit 6), a 12 week Maintenance Period began. Subjects had to titrate to at least 200 mg/day for subjects weighing >=50 kg in order to enter the Maintenance Period. The LCM dose remained stable throughout the Maintenance Period. Subjects who required a change in dose during the Maintenance Period were withdrawn from the study.

    Number of subjects in period 1
    Lacosamide 1 month - <4 years Lacosamide 4 years - <12 years Lacosamide 12 years - <18 years
    Started
    10
    24
    21
    Completed
    9
    21
    14
    Not completed
    1
    3
    7
         No effective dose in Titration period
    -
    -
    1
         Lack of efficacy
    -
    3
    1
         Adverse event, non-fatal
    -
    -
    3
         Consent withdrawn by subject
    1
    -
    1
         Sponsor decision
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide 1 month - <4 years
    Reporting group description
    Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 4 years - <12 years
    Reporting group description
    Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 12 years - <18 years
    Reporting group description
    Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group values
    Lacosamide 1 month - <4 years Lacosamide 4 years - <12 years Lacosamide 12 years - <18 years Total
    Number of subjects
    10 24 21 55
    Age categorical
    Units: Subjects
        <=18 years
    10 24 21 55
        Between 18 and 65 years
    0 0 0 0
        >=65 years
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    2.716 ± 0.765 6.969 ± 1.998 14.753 ± 1.766 -
    Gender categorical
    Units: Subjects
        Female
    0 9 15 24
        Male
    10 15 6 31

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide 1 month - <4 years
    Reporting group description
    Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 4 years - <12 years
    Reporting group description
    Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 12 years - <18 years
    Reporting group description
    Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Subject analysis set title
    Lacosamide 1 month - <4 years SS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Subject analysis set title
    Lacosamide 4 years - <2 years SS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Subject analysis set title
    Lacosamide 12 years - <18 years SS
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Primary: Mean changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 to Visit 6

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    End point title
    Mean changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 to Visit 6 [1]
    End point description
    The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
    End point type
    Primary
    End point timeframe
    From Baseline (Day 1) to Visit 6 (Week 6)
    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
    Lacosamide 1 month - <4 years SS Lacosamide 4 years - <2 years SS Lacosamide 12 years - <18 years SS
    Number of subjects analysed
    10
    24
    21
    Units: discharges
        arithmetic mean (standard deviation)
    -4.55 ± 257.32
    -166.22 ± 447.80
    -203.12 ± 432.42
    No statistical analyses for this end point

    Primary: Mean change in days with any generalized seizures (absence, myoclonic, clonic, tonic, tonic-clonic, atonic, partial evolving to secondarily generalized) per 28 days from the Baseline Period to the Maintenance Period (approximately 24 weeks)

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    End point title
    Mean change in days with any generalized seizures (absence, myoclonic, clonic, tonic, tonic-clonic, atonic, partial evolving to secondarily generalized) per 28 days from the Baseline Period to the Maintenance Period (approximately 24 weeks) [2]
    End point description
    The mean change in the count of days with generalized seizures was presented.
    End point type
    Primary
    End point timeframe
    Baseline Period to the Maintenance Period (approximately 24 weeks)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Lacosamide 1 month - <4 years SS Lacosamide 4 years - <2 years SS Lacosamide 12 years - <18 years SS
    Number of subjects analysed
    10
    23
    20
    Units: days
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.50 ± 6.63
    -1.90 ± 3.76
    -3.38 ± 6.42
    No statistical analyses for this end point

    Secondary: Mean changes in count of 3 Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 to Visit 6

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    End point title
    Mean changes in count of 3 Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 to Visit 6
    End point description
    The mean change in the count of 3 Hertz (Hz) spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) to Visit 6 (Week 6)
    End point values
    Lacosamide 1 month - <4 years SS Lacosamide 4 years - <2 years SS Lacosamide 12 years - <18 years SS
    Number of subjects analysed
    9
    22
    14
    Units: count of discharges
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -0.14 ± 0.42
    -1.60 ± 9.92
    0.00 ± 0.00
    No statistical analyses for this end point

    Secondary: Number of subject withdrawals due to Adverse Events from Baseline to End of Study (approximately 32 weeks)

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    End point title
    Number of subject withdrawals due to Adverse Events from Baseline to End of Study (approximately 32 weeks)
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline to End of Study (approximately 32 weeks)
    End point values
    Lacosamide 1 month - <4 years SS Lacosamide 4 years - <2 years SS Lacosamide 12 years - <18 years SS
    Number of subjects analysed
    10
    24
    21
    Units: participants
    0
    0
    3
    No statistical analyses for this end point

    Secondary: Number of subjects experiencing at least 1 Treatment-emergent Adverse event from Baseline to End of Study (approximately 32 weeks)

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    End point title
    Number of subjects experiencing at least 1 Treatment-emergent Adverse event from Baseline to End of Study (approximately 32 weeks)
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From Baseline to End of Study (approximately 32 weeks)
    End point values
    Lacosamide 1 month - <4 years SS Lacosamide 4 years - <2 years SS Lacosamide 12 years - <18 years SS
    Number of subjects analysed
    10
    24
    21
    Units: participants
    10
    21
    18
    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 throughout the study (up to week 26)
    Adverse event reporting additional description
    An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Lacosamide 1 month - <4 years
    Reporting group description
    Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 12 years - <18 years
    Reporting group description
    Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Reporting group title
    Lacosamide 4 years - <12 years
    Reporting group description
    Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.

    Serious adverse events
    Lacosamide 1 month - <4 years Lacosamide 12 years - <18 years Lacosamide 4 years - <12 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
    0 / 24 (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
    Lacosamide 1 month - <4 years Lacosamide 12 years - <18 years Lacosamide 4 years - <12 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    15 / 21 (71.43%)
    19 / 24 (79.17%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 21 (4.76%)
    4 / 24 (16.67%)
         occurrences all number
    1
    1
    4
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    4 / 10 (40.00%)
    2 / 21 (9.52%)
    2 / 24 (8.33%)
         occurrences all number
    4
    3
    2
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    4 / 21 (19.05%)
    0 / 24 (0.00%)
         occurrences all number
    6
    7
    0
    Tremor
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 21 (9.52%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    2
    Convulsion
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 21 (9.52%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    1
    Dizziness
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 21 (9.52%)
    1 / 24 (4.17%)
         occurrences all number
    0
    2
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 10 (40.00%)
    3 / 21 (14.29%)
    6 / 24 (25.00%)
         occurrences all number
    5
    3
    7
    Irritability
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 21 (4.76%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
    4 / 24 (16.67%)
         occurrences all number
    0
    1
    5
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 21 (9.52%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 21 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    2
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 21 (9.52%)
    0 / 24 (0.00%)
         occurrences all number
    2
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 10 (50.00%)
    3 / 21 (14.29%)
    1 / 24 (4.17%)
         occurrences all number
    7
    3
    1
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 21 (14.29%)
    1 / 24 (4.17%)
         occurrences all number
    2
    3
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 21 (9.52%)
    4 / 24 (16.67%)
         occurrences all number
    0
    2
    4
    Bronchitis
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 21 (9.52%)
    2 / 24 (8.33%)
         occurrences all number
    1
    3
    2
    Pharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 21 (4.76%)
    3 / 24 (12.50%)
         occurrences all number
    0
    1
    3
    Ear infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 21 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    3
    0
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2012
    This Amendment has been issued following a Special Protocol Assessment performed by the USA FDA on SP0969 (NCT01921205). Where applicable, the recommendations made by the FDA have been incorporated into the current protocol. Major changes: •Dosing was changed to match SP0969 (based on subject weight) •Inclusion criteria for concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS) were modified to match SP0969 •Subjects with primary generalized tonic-clonic seizures with a diagnosis of idiopathic generalized epilepsy were excluded. The effect of lacosamide (LCM) in this population is planned to be investigated in a confirmatory study •Exclusion criteria for felbamate and vigabatrin were modified •The Behavior Rating Inventory of Executive Function was added as an additional safety assessment •The Pediatric Quality of Life Inventory was added as an additional efficacy assessment •Health care resource use was added as an efficacy variable •The requirement to measure height was restricted to visits with a complete physical examination •Withdrawal criteria based on the use of rescue medication was added •An additional assessment at end of titration was added for the Achenbach Child Behavior Checklist. •Orthostatic blood pressure and pulse assessments were added •Concomitant, prohibited and rescue medications were modified to match SP0969 •The terminology “syrup” was replaced with oral solution •Assessment time points for scales and questionnaires were modified •Additional assessments for VNS assessments and urinalysis were added •The number of sites was increased to 40 •Additional text was added clarifying which version of the Columbia Suicide Severity Rating Scale (C-SSRS) should be used at study entry and for subjects turning 6 years of age. •Administrative changes •Typographical changes
    21 Jun 2013
    The present amendment has been issued following additional feedback from the USA FDA on both SP0969 and SP0966. Where applicable, the recommendations made by the FDA have been incorporated into the current protocol. In addition, updates were made for consistency with other lacosamide (LCM) protocols. The following major changes were made: •The titration and taper schedules were changed to include different weight categories, a 600 mg/day LCM dose, and an extended (slower) titration schedule. •The schedule of assessments was modified to include the changes to the titration schedule, additional visits, and changes to the assessments at each visit. •The schematic diagrams were updated to reflect the additional changes to the titration and taper schedules. •Inclusion criteria were modified to allow inclusion of subjects with West syndrome. •Measurements of head circumference were included. •The language regarding unscheduled visits was updated to make it clear that investigators can perform additional procedures based on their judgment and medical need. •The age allowed for initial enrollment was reduced from 4 to 2 years. •The duration of the safety follow-up was made consistent with other LCM studies (SP0969). •The definition of end of study for the subjects has been clarified to account for subjects who enter and do not enter the open-label study. •Additional language was added describing the procedures if the study is completed and the taper is not required at the end of the study. •The language regarding study medication storage has been updated according to the clinical label. •The language regarding some of the scales used in this study has been updated for clarification. •The number of sites and countries in the study were increased. •Administrative changes •Typographical changes
    25 Feb 2014
    The following key changes were made throughout the protocol: •Subjects with primary generalized tonic-clonic seizures (PGTCS) with a diagnosis of idiopathic generalized epilepsy (IGE) are not excluded from the study population. •Subjects >=1 month to <2 years of age can now be enrolled into SP0966. •Subjects with second- or third-degree heart block are excluded from SP0966, without the requirement of being at rest. •The atrioventricular (AV) block withdrawal criterion was modified to second or third degree AV block, without the requirement of being awake. •Head circumference is to be measured only in subjects <4 years of age. •Administrative changes: the name and details of the Clinical Project Manager and the Serious Adverse Event (SAE) Reporting Email address were updated.
    26 Feb 2015
    The following key changes were made throughout the protocol: •Subjects with primary generalized tonic-clonic seizures with a diagnosis of idiopathic generalized epilepsy were excluded from the study population. •Exclusion criterion for creatinine clearance rate has changed from <50 milliLiters/minute (mL/min) to <30 mL/min. •Exclusion criterion number 20 has been reworded to clarify that the excluded sodium channelopathies are cardiac. •Administrative changes: the name of the Study Physician and the name of the contract research organization (CRO) have been updated, and the Sponsor Declaration has been updated for electronic signature. •Russia has been removed as a participating country.

    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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