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    Clinical Trial Results:
    A Multicenter, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Lacosamide (LCM) Oral Solution (Syrup) as Adjunctive Therapy in Children with Partial-Onset Seizures

    Summary
    EudraCT number
    2011-001558-27
    Trial protocol
    BE   Outside EU/EEA  
    Global end of trial date
    26 Aug 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    15 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP847
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00938431
    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-PIP02-02
    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
    02 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study were: To evaluate the safety, tolerability, and pharmacokinetics (PK) of Lacosamide (LCM) when added to 1 to 3 concomitant antiepileptic drugs (AEDs) in children aged 1 month to 17 years with a diagnosis of uncontrolled partial-onset seizures. To obtain preliminary efficacy data on seizure frequency.
    Protection of trial subjects
    Informed consent was 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 according to local IRB/IEC, assent was also obtained from the subject.
    Background therapy
    N/A
    Evidence for comparator
    N/A
    Actual start date of recruitment
    04 Nov 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    8 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Belgium: 1
    Worldwide total number of subjects
    47
    EEA total number of subjects
    1
    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)
    12
    Children (2-11 years)
    26
    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
    The SP847 study began recruitment in November 2009. The study ended in August 2014 with 47 subjects enrolled into the study.

    Pre-assignment
    Screening details
    N/A

    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
    Total Subjects (Safety Set)
    Arm description
    The Safety Set is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP847.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    VIMPAT
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Lacosamide oral solution (syrup) 8 mg/kg/day, 10 mg/kg/day, and/or 12 mg/kg/day. Depending on the target dose, treatment duration can last up to 42 days.

    Number of subjects in period 1
    Total Subjects (Safety Set)
    Started
    47
    Completed
    24
    Not completed
    23
         Non-Fatal, Serious AE
    2
         Reached Maximum Dose Early
    1
         Lack of efficacy
    1
         Non-Fatal, Non-Serious AE
    17
         Dosing Compliance Issue
    1
         Did Not Up Titrate to 12 mg kg/day
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Total Subjects (Safety Set)
    Reporting group description
    The Safety Set is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP847.

    Reporting group values
    Total Subjects (Safety Set) Total
    Number of subjects
    47 47
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        geometric mean (standard deviation)
    7.03 ± 5.12 -
    Gender Categorical
    Units: Subjects
        Male
    23 23
        Female
    24 24
    Racial Group
    Units: Subjects
        Asian
    2 2
        Black
    7 7
        White
    30 30
        Other/ Mixed
    8 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    21 21
        Not Hispanic or Latino
    26 26
    Weight
    Units: kilograms
        geometric mean (standard deviation)
    26.6 ± 17.64 -
    Height
    Units: centimeters
        geometric mean (standard deviation)
    115.46 ± 31.23 -
    BMI
    Units: kg/m^2
        geometric mean (standard deviation)
    17.48 ± 3.37 -

    End points

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    End points reporting groups
    Reporting group title
    Total Subjects (Safety Set)
    Reporting group description
    The Safety Set is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP847.

    Subject analysis set title
    Total Subjects (Full Analysis Set)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) is defined as all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP847 study.

    Primary: Number of subjects that report at least one Treatment-emergent Adverse Event during the study (approximately 13 weeks)

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    End point title
    Number of subjects that report at least one Treatment-emergent Adverse Event during the study (approximately 13 weeks) [1]
    End point description
    End point type
    Primary
    End point timeframe
    13 weeks
    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: The primary objective of study SP847 was to evaluate the safety, tolerability, and PK of lacosamide when added to 1 to 3 concomitant AEDs in children aged 1 month to 17 years with a diagnosis of uncontrolled partial-onset seizures. The safety profile of lacosamide was summarized descriptively across several safety variables. Therefore, no inferential statistics were performed in this safety study.
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    47
    Units: participants
        number
    42
    No statistical analyses for this end point

    Secondary: Percent change in seizure frequency from Baseline to End of Treatment

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    End point title
    Percent change in seizure frequency from Baseline to End of Treatment
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to End of Treatment
    End point values
    Total Subjects (Full Analysis Set)
    Number of subjects analysed
    46
    Units: percentage
    arithmetic mean (standard deviation)
        percentage
    21.72 ± 94.59
    No statistical analyses for this end point

    Secondary: Caregiver Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination

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    End point title
    Caregiver Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination
    End point description
    For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse Note: The category of Worsened represents the sum of Minimally Worse, Much Worse, and Very Much Worse. The category of Improved represents the sum of Very Much Improved, Much Improved, and Minimally Improved.
    End point type
    Secondary
    End point timeframe
    Visit 5 (Day 27/28) or Early Termination
    End point values
    Total Subjects (Full Analysis Set)
    Number of subjects analysed
    44
    Units: units on a scale
        Improved
    38
        No Change
    3
        Worsened
    3
    No statistical analyses for this end point

    Secondary: Clinical Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination

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    End point title
    Clinical Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination
    End point description
    For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: 1. Very much improved 2. Much improved 3. Minimally improved 4. No Change 5. Minimally worse 6. Much worse 7. Very much worse Note: The category of Worsened represents the sum of Minimally Worse, Much Worse, and Very Much Worse. The category of Improved represents the sum of Very Much Improved, Much Improved, and Minimally Improved.
    End point type
    Secondary
    End point timeframe
    Visit 5 (Day 27/28) or Early Termination
    End point values
    Total Subjects (Full Analysis Set)
    Number of subjects analysed
    45
    Units: units on a scale
        Improved
    38
        No Change
    3
        Worsened
    4
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for Lacosamide at Day 7

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    End point title
    Plasma Ctrough values for Lacosamide at Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    45
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    839.9 ± 64.1
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for Lacosamide at Day 28

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    End point title
    Plasma Ctrough values for Lacosamide at Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    3886 ± 70.2
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for Lacosamide at Day 35

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    End point title
    Plasma Ctrough values for Lacosamide at Day 35
    End point description
    End point type
    Secondary
    End point timeframe
    Day 35
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    5
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    4033.8 ± 52.5
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for Lacosamide at Day 42

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    End point title
    Plasma Ctrough values for Lacosamide at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    14
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    4169.5 ± 73.3
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for SPM 12809 at Day 7

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    End point title
    Plasma Ctrough values for SPM 12809 at Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    45
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    258.4 ± 44.6
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for SPM 12809 at Day 28

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    End point title
    Plasma Ctrough values for SPM 12809 at Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    6
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    754.9 ± 21.1
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for SPM 12809 at Day 35

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    End point title
    Plasma Ctrough values for SPM 12809 at Day 35
    End point description
    End point type
    Secondary
    End point timeframe
    Day 35
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    5
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    955.1 ± 24.7
    No statistical analyses for this end point

    Secondary: Plasma Ctrough values for SPM 12809 at Day 42

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    End point title
    Plasma Ctrough values for SPM 12809 at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    Total Subjects (Safety Set)
    Number of subjects analysed
    14
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        percentage
    1725.8 ± 39.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (October 2009 - August 2014). The analysis group for AEs and SAEs was the Safety Set.
    Adverse event reporting additional description
    The Safety Set is comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP847. Subjects had the ability to report more than one event. The Serious Adverse Events and Non-serious Adverse Events sections are reported in this manner.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Total Subjects (Safety Set)
    Reporting group description
    -

    Serious adverse events
    Total Subjects (Safety Set)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 47 (12.77%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Status epilepticus
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia viral
         subjects affected / exposed
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
         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
    Total Subjects (Safety Set)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 47 (72.34%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    6 / 47 (12.77%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    6
    Balance disorder
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    4
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    5 / 47 (10.64%)
         occurrences all number
    6
    Gait disturbance
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    10 / 47 (21.28%)
         occurrences all number
    12
    Diarrhoea
         subjects affected / exposed
    7 / 47 (14.89%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 47 (8.51%)
         occurrences all number
    4
    Infections and infestations
    Otitis media
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3
    Pharyngotonsillitis
         subjects affected / exposed
    3 / 47 (6.38%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2009
    A Single-dose Reduction and Early Termination Protocol Clarification document was attached as a supplement to the protocol. In general, this attachment clarified that if a subject had a dose reduction, he/she would have been terminated early from the study after sufficient PK data were collected. The AEs of special interest were revised to reflect the Sponsor’s current understanding of the potential risks of LCM based on a comprehensive review of the data from clinical studies and commitments to regulatory agencies. The liver function test (LFT) withdrawal criteria were revised to reflect the Sponsor’s current understanding of the safety profile of LCM based on a comprehensive review of the data from clinical studies.
    27 Sep 2010
    The study was expanded to include approximately 25 investigational sites in the USA and Mexico, with the possibility to extend to other countries if deemed necessary. The clinic visit at Day 6 (including the overnight hospitalization) was made optional for additional subjects in Cohort 1 and for all subjects in Cohorts 2, 3, and 4; subjects in these cohorts were permitted to have all Visit 3 procedures performed during a clinic visit on Day 7. The clinic visit (including the overnight hospitalization) at Day 27 (Visit 5, if the maximum recommended dose did not exceed LCM 8mg/kg/day), Day 34 (Visit 6, if the maximum recommended dose was LCM 10mg/kg/day), or Day 41 (Visit 7, if the maximum recommended dose was LCM 12mg/kg/day) was also optional for those subjects in Cohort 1 (additional subjects), Cohorts 2, 3, and 4 who were not expected to provide urine samples for pharmacokinetic (PK) analysis (eg, subjects aged <5 years); these subjects were permitted to have all Visit 5, Visit 6, or Visit 7 procedures performed during a clinic visit on the second day of each of these scheduled visits (ie, Day 28, Day 35, or Day 42). The analysis of PK data from Cohort 1 was clarified. Subjects in Cohort 1 who did not achieve a maximum dose of LCM 8mg/kg/day because of tolerability issues, but did complete the Treatment Period (ie, the collection of blood samples for PK analysis during Visit 3 and Visit 5 [or the Early Termination Visit]) contributed toward the 6 subjects needed for the determination of the maximum recommended dose for subsequent cohorts. Completion of the Treatment Period was defined as any subject who achieved steady-state at LCM ≥4mg/kg/day and completed the Early Termination Visit or Visit 5 procedures.
    13 Dec 2010
    The primary purposes of this protocol amendment were to include an additional cohort (now designated as Cohort 5) of subjects aged ≥1 month to <2 years, to define an absolute maximum dose of LCM 600 mg/day to be received by subjects in the study, to add an exclusion criterion for known sodium channelopathy, and to revise withdrawal criteria and follow-up recommendations for abnormal Liver Function Tests (LFTs). The rationales for these changes are described below. An additional cohort (now designated as Cohort 5) of 12 subjects aged ≥1 month to <2 years was included in the study. The addition of the younger subjects in Cohort 4 (previously planned for a separate clinical study of similar design) was to permit an earlier assessment of LCM PK and determination of dosing in pediatric subjects before initiating Phase 3 pediatric studies. Based on the analysis of SP847 Cohort 1 (subjects aged ≥5 to 11 years) safety and PK data, the maximum permitted LCM dose in SP847 Cohorts 2 to 5 was LCM 12 mg/kg/day (for subjects weighing up to 50 kg) or LCM 600 mg/day (for subjects weighing >50 kg). The decision to exclude subjects with known channelopathies, such as Brugada syndrome, from clinical studies with LCM was based on a Food and Drug Administration (FDA) recommendation (17 Aug 2010). The basis for this recommendation was a theoretical concern that enhanced slow inactivation of sodium channels by LCM may be proarrhythmic in subjects with sodium channelopathies.
    29 Jul 2011
    - Text was added or modified to make it clear that the maximum permitted dose in SP847 was LCM 12 mg/kg/day or LCM 600 mg/day, whichever was lower. - Columbia-Suicide Severity Rating Scale was added to evaluate and identify subjects at risk for suicide while participating in a clinical study of a drug with central nervous system activity. - Changed from LCM oral solution 15 mg/mL to LCM oral (syrup) solution 10 mg/mL due to a quality defect related to the formation of a flake-like precipitate of LCM in the 15 mg/mL syrup. - Beginning with Visit 5 (the visit at which subject had been on LCM 8 mg/kg/day for 6 to 7 days) and for subsequent visits, the remaining subjects enrolled into SP847 were required to arrive at the clinic prior to taking their morning dose of LCM. Subjects were administered their morning LCM dose by study personnel at the clinic so that an ECG could be performed 30 minutes to 1 hour after the administration of LCM. - A list of anticipated serious adverse events was included in this amendment in compliance with the USA FDA guidance on safety reporting requirements for studies conducted under an open Investigational New Drug Application. - The exclusion criterion limiting subjects who had a history of suicide attempt, had received professional counseling for suicidal ideation, or those who were currently experiencing suicidal ideation, was deleted.
    23 Jul 2012
    The primary purpose of this protocol amendment was to reduce from 2 to 1 the required minimum total number of AEDs (current or past) to have been taken by subjects in Cohort 5 (subjects 1 month to <2 years of age). This change may have increased the number of subjects in Cohort 5 who were eligible for the study. It is possible that subjects in this youngest age range may not have received AEDs for a period of time long enough for >1 AED to have been used. In addition, the exclusion criterion limiting eligible subjects to those who were able to swallow or take food by mouth was deleted (Exclusion criterion 21). A result of this change is that subjects who had a feeding tube may have been eligible for enrollment in the study and may have received LCM oral solution via a feeding tube. Previous tests have demonstrated that the LCM oral solution is compatible with administration via a feeding tube.
    05 Oct 2012
    In the FDA’s 06 Aug 2012 Request for Information regarding SP847 Protocol Amendment 5, the Agency recommended that UCB BIOSCIENCES revise inclusion criterion 6 to require the use of >1 AED as monotherapy before initiating adjunctive LCM therapy in SP847. In accordance with UCB BIOSCIENCES 29 Aug 2012 Response to Request for Information, the primary purpose of this protocol amendment was to modify inclusion criterion 6 to require for all subjects a minimum total of 2 antiepileptic drugs (AEDs) (current or past) before initiation of adjunctive treatment with LCM in SP847.
    31 Jul 2014
    The primary purposes of this protocol amendment were to update the use of the Safety Set (SS), Full Analysis Set (FAS), Evaluable Set (EVS), and Pharmacokinetic Per-Protocol Set (PK-PPS) analysis sets for evaluation of safety, efficacy, and PK variables such that they reflect the planned analyses included in the Statistical Analysis Plan (SAP). Additional changes were made to clarify study procedures and variables for consistency across the protocol, SAP, and Pediatric Investigational Plan Final Opinion. The changes included in this amendment were administrative in nature and did not impact the treatment of subjects during the course of 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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