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    Clinical Trial Results:
    A MULTICENTER, OPEN-LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS WITH EPILEPSY WITH PARTIAL-ONSET SEIZURES

    Summary
    EudraCT number
    2012-005012-26
    Trial protocol
    BE   IT   CZ   SK   HU   ES   EE   PL   GB   LV   RO   BG   LT   Outside EU/EEA   SE   SI   HR   DE   FR   GR   PT   DK   FI  
    Global end of trial date
    13 Apr 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Oct 2022
    First version publication date
    16 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP0034
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01964560
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES Inc.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, NC 27617
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Apr 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of lacosamide in pediatric subjects
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    1 to 3 concomitant antiepileptic drugs (AEDs) as permitted in the protocol
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    13 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Brazil: 6
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    China: 14
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Croatia: 20
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Georgia: 47
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hungary: 51
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Mexico: 36
    Country: Number of subjects enrolled
    Montenegro: 2
    Country: Number of subjects enrolled
    Poland: 33
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 17
    Country: Number of subjects enrolled
    Moldova, Republic of: 2
    Country: Number of subjects enrolled
    Philippines: 2
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    Slovakia: 14
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    Thailand: 34
    Country: Number of subjects enrolled
    Ukraine: 74
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    540
    EEA total number of subjects
    199
    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)
    103
    Children (2-11 years)
    287
    Adolescents (12-17 years)
    150
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll participants in August 2014 and concluded in April 2022.

    Pre-assignment
    Screening details
    The Participant Flow refers to the Safety Set (SS). The SS included all enrolled study participants who took at least 1 dose of lacosamide (LCM) in this long-term extension study.

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

    Arms
    Arm title
    Lacosamide (All subjects)
    Arm description
    Participants who participated in primary study [SP0967 (NCT02477839) or SP0969 (NCT01921205)] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing <30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing >=30 kg to <50 kg, and LCM 300 mg/day as tablets for study participants weighing >=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    LCM
    Other name
    VIMPAT
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received LCM administered orally at pre-defined timepoints.

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    LCM
    Other name
    VIMPAT
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received LCM administered orally at pre-defined timepoints.

    Number of subjects in period 1
    Lacosamide (All subjects)
    Started
    540
    Completed
    395
    Not completed
    145
         Patient was prescribed CBD
    1
         Surgery
    1
         Lack of efficacy
    46
         Seizures appeared resolved with epilepsy surgery
    1
         Adverse event, non-fatal
    23
         Participant moved to another country
    1
         Surgery-hemispherotomy
    1
         Consent withdrawn by subject
    64
         Protocol deviation
    2
         Patient and Investigator choice
    1
         Lost to follow-up
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide (All subjects)
    Reporting group description
    Participants who participated in primary study [SP0967 (NCT02477839) or SP0969 (NCT01921205)] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing <30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing >=30 kg to <50 kg, and LCM 300 mg/day as tablets for study participants weighing >=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.

    Reporting group values
    Lacosamide (All subjects) Total
    Number of subjects
    540 540
    Age Categorical
    Units: participants
        >=28 days - <24 months
    103 103
        >=24 months - <12 years
    287 287
        >=12 - <18 years
    150 150
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    7.486 ± 5.415 -
    Sex: Female, Male
    Units: participants
        Female
    236 236
        Male
    304 304

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide (All subjects)
    Reporting group description
    Participants who participated in primary study [SP0967 (NCT02477839) or SP0969 (NCT01921205)] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing <30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing >=30 kg to <50 kg, and LCM 300 mg/day as tablets for study participants weighing >=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.

    Primary: Percentage of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    Percentage of participants with treatment-emergent adverse events (TEAEs) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. The Safety Set (SS) included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.
    End point type
    Primary
    End point timeframe
    From Week 0 to the End of Safety Follow-Up (up to Week 104)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide (All subjects)
    Number of subjects analysed
    540
    Units: percentage of participants
        number (not applicable)
    77.2
    No statistical analyses for this end point

    Primary: Percentage of participants with serious TEAEs

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    End point title
    Percentage of participants with serious TEAEs [2]
    End point description
    A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.
    End point type
    Primary
    End point timeframe
    From Week 0 to the End of Safety Follow-Up (up to Week 104)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide (All subjects)
    Number of subjects analysed
    540
    Units: percentage of participants
        number (not applicable)
    20.6
    No statistical analyses for this end point

    Primary: Percentage of participants with TEAEs leading to study discontinuation

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    End point title
    Percentage of participants with TEAEs leading to study discontinuation [3]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose. The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study. Here, only those participants who discontinued the study due to TEAEs starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose of LCM are reported.
    End point type
    Primary
    End point timeframe
    From Week 0 to the End of Safety Follow-Up (up to Week 104)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide (All subjects)
    Number of subjects analysed
    540
    Units: percentage of participants
        number (not applicable)
    4.1
    No statistical analyses for this end point

    Secondary: Percentage of seizure-free days during the study

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    End point title
    Percentage of seizure-free days during the study
    End point description
    The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only. The Full Analysis Set (FAS) was used for the analysis of seizure data and included all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Study participants whose efficacy data could not be source verified were excluded from the FAS. Here, Number of participants analyzed included those participants who were evaluable for the assessment.
    End point type
    Secondary
    End point timeframe
    From Week 0 to End of Treatment (up to Week 96)
    End point values
    Lacosamide (All subjects)
    Number of subjects analysed
    537
    Units: percentage of seizure free days
        arithmetic mean (standard deviation)
    66.96 ± 36.18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 0 to the End of Safety Follow-Up (up to Week 104)
    Adverse event reporting additional description
    TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Lacosamide (All subjects)
    Reporting group description
    Participants who participated in primary study [SP0967 (NCT02477839) or SP0969 (NCT01921205)] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing <30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing >=30 kg to <50 kg, and LCM 300 mg/day as tablets for study participants weighing >=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.

    Serious adverse events
    Lacosamide (All subjects)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    111 / 540 (20.56%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Brain operation
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Device malfunction
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Device breakage
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Emotional disorder of childhood
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lip injury
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth fracture
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood bicarbonate decreased
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urine output decreased
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Congenital, familial and genetic disorders
    Cerebral palsy
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Talipes
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Pneumonia aspiration
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Apnoea
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chylothorax
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoventilation
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    24 / 540 (4.44%)
         occurrences causally related to treatment / all
    1 / 30
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    9 / 540 (1.67%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    Epilepsy
         subjects affected / exposed
    7 / 540 (1.30%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    Partial seizures
         subjects affected / exposed
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Somnolence
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Motor dysfunction
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myoclonic epilepsy
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonic convulsion
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parophthalmia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    10 / 540 (1.85%)
         occurrences causally related to treatment / all
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Pyuria
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle haemorrhage
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acetonaemia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enteral feeding intolerance
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypophagia
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    11 / 540 (2.04%)
         occurrences causally related to treatment / all
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Dengue fever
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Corona virus infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lacosamide (All subjects)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    289 / 540 (53.52%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    38 / 540 (7.04%)
         occurrences all number
    49
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    30 / 540 (5.56%)
         occurrences all number
    42
    Headache
         subjects affected / exposed
    29 / 540 (5.37%)
         occurrences all number
    89
    Convulsion
         subjects affected / exposed
    27 / 540 (5.00%)
         occurrences all number
    33
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    86 / 540 (15.93%)
         occurrences all number
    149
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    56 / 540 (10.37%)
         occurrences all number
    113
    Diarrhoea
         subjects affected / exposed
    42 / 540 (7.78%)
         occurrences all number
    54
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    83 / 540 (15.37%)
         occurrences all number
    167
    Nasopharyngitis
         subjects affected / exposed
    57 / 540 (10.56%)
         occurrences all number
    92
    Pharyngitis
         subjects affected / exposed
    39 / 540 (7.22%)
         occurrences all number
    68
    Bronchitis
         subjects affected / exposed
    33 / 540 (6.11%)
         occurrences all number
    46
    Influenza
         subjects affected / exposed
    28 / 540 (5.19%)
         occurrences all number
    35

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2015
    Protocol Amendment 1, dated 30 Jun 2015, provided the following key changes. Based on the date of the amendment, 63 study participants were screened (enrolled into EP0034) prior to this amendment (Table 1.5). The primary purpose of this substantial amendment was to add further clarification regarding the addition of extra procedures electrocardiograms (ECGs) in case of LCM dose increases to ≥8 mg/kg/day and ≥400 mg/day or in case of addition of new concomitant antiepileptic drugs (AEDs), in accordance with the Food and Drug Administration (FDA) request and based on program specific guidelines. Furthermore, at the request of the Spanish Independent Ethics Committee (IEC), additional inclusion criteria (Inclusion Criterion #5 and #6) were added to clarify age and diagnosis requirements for enrollment. Additional changes were implemented for consistency with other protocols in the LCM pediatric program and administrative changes including the update of the study team and minor corrections, and update of the Sponsor Declaration for electronic signature, were made.
    24 Mar 2017
    Protocol Amendment 2, dated 24 Mar 2017, provided the following key changes. Based on the date of the amendment, 362 study participants were screened (enrolled into EP0034) prior to this amendment (Table 1.5). The primary purpose of this substantial amendment was to allow administration of the Pediatric Quality of Life Inventory (PedsQL) to study participants under 2 years of age and to implement language regarding potential drug-induced liver injury (PDILI) events, based on new standard language which was applied across all protocols at UCB. Addition of this language was to align with FDA guidance regarding monitoring of potential drug-induced liver injury (PDILI) events and did not reflect a change in the liver safety signal for LCM. Permitted and prohibited concomitant medications were also updated and language clarified; neuroleptics (except for clozapine) were allowed during the study and cannabidiols (not approved or indicated for epilepsy by local health authority) were prohibited during the study.

    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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