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    Clinical Trial Results:
    A multicenter, open-label study to investigate the pharmacokinetics of commercial lacosamide oral formulation as therapy in children (aged 1 month to 17 years) with epilepsy.

    Summary
    EudraCT number
    		 2014-002629-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    11 Feb 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP1047
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Biosciences Inc
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, 27617
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, 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-PIP02-11
    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
    24 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the Pharmacokinetics of lacosamide in children with epilepsy, aged 1 month to 17 years.
    Protection of trial subjects
    Informed consent were obtained from the subject’s parent/ legal guardian and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. When possible or as required by the local IRB/IEC, assent was obtained from the subject. Prior to obtaining informed consent, information was given in a language and at a level of complexity understandable to the subject and/ or the subject’s parent/legal guardian in both oral and written form by the investigator or designee. Each subject and/or subject’s parent/legal guardian had the opportunity to discuss the study and its alternatives with the investigator.
    Background therapy
    		 Subject had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening and had not been prescribed or maintained on LCM for the purposes of participating in this study. Lacosamide dose was stable for at least 7 days, and intake of the prescribed total daily dose confirmed for at least 3 days prior to participation. Subject was on a stable AED dosage regimen. The daily dosage regimen of concomitant AED(s) therapy must have been kept stable for a period of at least 1 week (7 days) prior to participation.
    Evidence for comparator
    		 Not Applicable
    Actual start date of recruitment
    11 Apr 2011
    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
    United States: 32
    Worldwide total number of subjects
    32
    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)
    0
    Infants and toddlers (28 days-23 months)
    2
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    9
    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
    		 Recruitment for the SP1047 study began in April 2011. The overall study concluded in July 2014. This was a multicenter study with subjects enrolled by 9 sites across the United States of America.

    Pre-assignment
    Screening details
    		 The SP1047 study screened 34 patients. Out of the 34 patients, 2 subjects failed screening. This led to 32 subjects entering the SP1047 study.

    Period 1
    Period 1 title
    Overall Study Population (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Arm title
    		 Lacosamide, Commercially Available
    Arm description
    		 Male or female subjects (1 month to 17 years of age) who had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening.
    Arm type
    		 Commercially available

    Investigational medicinal product name
    Commercially available, prescribed lacosamide
    Investigational medicinal product code
    SPM927
    Other name
    VIMPAT
    Pharmaceutical forms
    Oral solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Active substance: Lacosamide Pharmaceutical form: Tablet and oral solution Concentration: Tablets: 50 mg, 100 mg, 150 mg 200 mg, or Oral solution: 10 mg/ml Route of Administration: Oral

    Number of subjects in period 1
    		Lacosamide, Commercially Available
    Started
    32
    Completed
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study Population
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Population Total
    Number of subjects
    		 32 32
    Age categorical
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: Subjects
        28 days - <24 months
    		 2 2
        24 months - <12 years
    		 21 21
        12 years - <18 years
    		 9 9
    Age continuous
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: years
        arithmetic mean (standard deviation)
    		 8.93 ( 5.34 ) -
    Gender categorical
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: Subjects
        Female
    		 18 18
        Male
    		 14 14
    Racial Group
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: Subjects
        American Indian/ Alaskan Native
    		 0 0
        Asian
    		 0 0
        Black
    		 6 6
        Native Hawaiian or other Pacific Islander
    		 0 0
        White
    		 21 21
        Other/ mixed
    		 5 5
    Ethnicity
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: Subjects
        Hispanic or Latino
    		 5 5
        Not Hispanic or Latino
    		 27 27
    Weight
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 32 ( 19.44 ) -
    Time Since Diagnosis
    The demographics and baseline characteristics consist of subjects in the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel.
    Units: years
        arithmetic mean (standard deviation)
    		 5.22 ( 4.85 ) -

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide, Commercially Available
    Reporting group description
    		 Male or female subjects (1 month to 17 years of age) who had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening.

    Primary: The total number of subjects experiencing at least one Adverse Event (AE) during the study

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    End point title
    		 The total number of subjects experiencing at least one Adverse Event (AE) during the study [1]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which 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.
    End point type
    Primary
    End point timeframe
    AEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome.
    End point values
    		 Lacosamide, Commercially Available
    Number of subjects analysed
    32 [2]
    Units: participants
    1
    Notes
    [2] - Analysis group: Safety Set (SS).
    No statistical analyses for this end point

    Primary: The total number of subject withdrawal due to at least one Adverse Event (AE) during the study

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    End point title
    		 The total number of subject withdrawal due to at least one Adverse Event (AE) during the study [3]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which 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.
    End point type
    Primary
    End point timeframe
    AEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
    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: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome.
    End point values
    		 Lacosamide, Commercially Available
    Number of subjects analysed
    32 [4]
    Units: participants
    0
    Notes
    [4] - Analysis group: Safety Set (SS).
    No statistical analyses for this end point

    Primary: The total number of subjects experiencing at least one Serious Adverse Event (SAE) during the study

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    End point title
    		 The total number of subjects experiencing at least one Serious Adverse Event (SAE) during the study [5]
    End point description
    An SAE meets 1 or more of the following criteria: -Death -Life-threatening -Significant or persistent disability/ incapacity -Congenital anomaly/ birth defect -Important medical event based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the definition of serious -Initial inpatient hospitalization or prolonged hospitalization
    End point type
    Primary
    End point timeframe
    SAEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
    Notes
    [5] - 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: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome.
    End point values
    		 Lacosamide, Commercially Available
    Number of subjects analysed
    32 [6]
    Units: participant
    0
    Notes
    [6] - Analysis group: Safety Set (SS).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
    Adverse event reporting additional description
    Adverse event reporting consists of the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel. There were no Serious Adverse Events (SAEs) reported during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Adverse event reporting consists of the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel. There were no Serious Adverse Events (SAEs) reported during the study.

    Serious adverse events
    		 Overall Study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall Study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2011
    The primary purpose of this substantial amendment was to introduce the stratification of subjects by age category to ensure that an appropriate number of subjects were included in each age range. This stratification was based on recommendations received from the United States' Federal Drug Administration (FDA) at a Type C meeting held on 07 Mar 2011.

    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.
    Study SP1047 was terminated prematurely as sufficient pharmacokinetic data had been collected to determine the dosing scheme for subsequent studies.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23859801
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