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    Clinical Trial Results:
    A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age from 1 Month to Less Than 4 Years of Age

    Summary
    EudraCT number
    		 2004-000199-14
    Trial protocol
    		 CZ   GB   BE   HU   IT  
    Global end of trial date
    26 Jan 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N01009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00175890
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB, Inc.
    Sponsor organisation address
    1950 Lake Park Drive, Smyrna, United States, 30080
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, 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
    22 Mar 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of levetiracetam (LEV) used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with refractory partial onset seizures.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    15 Oct 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Ethical reason
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Brazil: 26
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    116
    EEA total number of subjects
    44
    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)
    61
    Children (2-11 years)
    55
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This double-blind, randomized, multicenter, placebo-controlled, in-Patient study started recruiting in October 2004.

    Pre-assignment
    Screening details
    		 The Intent-to-treat (ITT) Population consisted of all randomized subjects who took at least one dose of study drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

    Arm title
    		 Levetiracetam
    Arm description
    		 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levetiracetam (LEV)
    Investigational medicinal product code
    LEV
    Other name
    Keppra
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.

    Number of subjects in period 1
    		Placebo Levetiracetam
    Started
    56
    60
    Completed
    53
    58
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    -
         AE, non-serious non-fatal
    -
    2
         SAE, non-fatal
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Reporting group title
    Levetiracetam
    Reporting group description
    		 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Reporting group values
    		 Placebo Levetiracetam Total
    Number of subjects
    		 56 60 116
    Age categorical
    Units: Subjects
        0 - <=27 days
    		 0 0 0
        28 days - <24 months
    		 29 32 61
        24 months - <12 years
    		 27 28 55
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 23.46 ± 12.06 23.4 ± 13.43 -
    Gender Categorical
    Units: Subjects
        Male
    		 27 30 57
        Female
    		 29 30 59
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 39 54 93
        American Indian or Alaska Native
    		 2 4 6
        Other/ mixed race
    		 8 2 10
        Black
    		 6 0 6
        Asian
    		 1 0 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 16 22 38
        Not Hispanic or Latino
    		 40 38 78

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Reporting group title
    Levetiracetam
    Reporting group description
    		 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Subject analysis set title
    Modified Intent-to-Treat (LEV treated Subjects)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population consisted of all intent to treat (ITT) subjects who had at least 24 hours of usable Selection video-EEG time (as determined by a central reader). Furthermore, subjects were included if they met the following criteria: • At least 24 hours of usable Evaluation video-EEG time, or • If < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy. These subjects were deemed non-responders (for the primary endpoint).

    Subject analysis set title
    Modified Intent-to-Treat (Placebo treated Subjects)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population consisted of all intent to treat (ITT) subjects who had at least 24 hours of usable Selection video-EEG time (as determined by a central reader). Furthermore, subjects were included if they met the following criteria: • At least 24 hours of usable Evaluation video-EEG time, or • If < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy. These subjects were deemed non-responders (for the primary endpoint).

    Subject analysis set title
    Intent-to-Treat (LEV treated Subjects)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Population consisted of all the randomized subjects who took at least one dose of study drug.

    Subject analysis set title
    Subset of mITT (LEV treated Subjects)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects 1 Month to < 6 Months of Age from the mITT. The mITT population consisted of all intent to treat (ITT) subjects who had at least 24 hours of usable Selection video-EEG time (as determined by a central reader).

    Subject analysis set title
    Intent-to-Treat (Placebo treated Subjects)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Population consisted of all the randomized subjects who took at least one dose of study drug.

    Subject analysis set title
    Subset of mITT (Placebo treated Subjects)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects 1 Month to < 6 Months of Age from the mITT. The mITT population consisted of all intent to treat (ITT) subjects who had at least 24 hours of usable Selection video-EEG time (as determined by a central reader).

    Primary: Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)

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    End point title
    		 Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
    End point description
    Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for partial onset seizures divided by the total number of subjects. If a subject had < 24 hours of usable Evaluation video-EEG time (including zero time available) and withdrawal from the study with reasons linked to lack or loss of efficacy, the subject was counted as a non-responder.
    End point type
    Primary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    51
    58
    Units: percentage of participants
    number (not applicable)
        Responder (percentage)
    19.6
    43.1
        Non-Responder (percentage)
    80.4
    56.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Modified Intent-to-Treat (LEV treated Subjects) v Modified Intent-to-Treat (Placebo treated Subjects)
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 Fisher exact
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 8.26

    Secondary: Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)

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    End point title
    		 Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)
    End point description
    Responder Rate is defined as the number of subjects with a ≥ 50 % reduction from baseline in their Average Daily Frequency (ADF) for all seizure types divided by the total number of subjects. Subjects who withdrew or dropped out before the first 24 hours Evaluation video-EEG with reasons linked to lack of efficacy were considered as non-responders. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    51
    58
    Units: percentage of participants
    number (not applicable)
        Responder (percentage)
    19.6
    43.1
        Non-Responder (percentage)
    80.4
    56.9
    No statistical analyses for this end point

    Secondary: Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

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    End point title
    		 Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
    End point description
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement.
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    50
    55
    Units: Percent reduction
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    -20.93 ± 111.47
    24.98 ± 91.49
    No statistical analyses for this end point

    Secondary: Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

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    End point title
    		 Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
    End point description
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    50
    55
    Units: Percent reduction
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    -20.93 ± 111.47
    25.08 ± 91.56
    No statistical analyses for this end point

    Secondary: Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

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    End point title
    		 Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
    End point description
    A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement.
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    51
    58
    Units: Absolute reduction
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    -0.86 ± 13.81
    8.54 ± 25.67
    No statistical analyses for this end point

    Secondary: Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

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    End point title
    		 Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG
    End point description
    A positive value in Absolute reduction from Selection Period to Evaluation Period indicates an improvement. All (total) seizures were defined as the total of Type I (partial onset) + Type II (Primary generalized) + Type III (unclassified epileptic).
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Modified Intent-to-Treat (Placebo treated Subjects) Modified Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    51
    58
    Units: Absolute reduction
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    -0.86 ± 13.81
    9.12 ± 26.35
    No statistical analyses for this end point

    Secondary: Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old

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    End point title
    		 Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old
    End point description
    A positive value in Percent reduction from Selection Period to Evaluation Period indicates an improvement. For children 1 month to less than 6 months old, partial onset seizure counts were based on electro-clinical seizures plus electrographic seizures.
    End point type
    Secondary
    End point timeframe
    48-hours in Evaluation Period and 48-hours in Selection Period
    End point values
    		 Subset of mITT (Placebo treated Subjects) Subset of mITT (LEV treated Subjects)
    Number of subjects analysed
    4
    3
    Units: Percent reduction
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    28.46 ± 44.89
    63.72 ± 28.41
    No statistical analyses for this end point

    Secondary: Percentage of drop-outs for any reasons during the study

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    End point title
    		 Percentage of drop-outs for any reasons during the study
    End point description
    End point type
    Secondary
    End point timeframe
    During the study (up to 20 days)
    End point values
    		 Intent-to-Treat (Placebo treated Subjects) Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    56
    60
    Units: percentage of participants
    number (not applicable)
        Drop-outs (percentage)
    5.4
    3.3
    No statistical analyses for this end point

    Secondary: Percentage of drop-outs due to lack of efficacy during the study

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    End point title
    		 Percentage of drop-outs due to lack of efficacy during the study
    End point description
    End point type
    Secondary
    End point timeframe
    During the study (up to 20 days)
    End point values
    		 Intent-to-Treat (Placebo treated Subjects) Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    56
    60
    Units: percentage of participants
    number (not applicable)
        Drop-outs (percentage)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy

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    End point title
    		 Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy
    End point description
    End point type
    Secondary
    End point timeframe
    During the study (up to 20 days)
    End point values
    		 Intent-to-Treat (Placebo treated Subjects) Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    56
    60
    Units: percentage of participants
    number (not applicable)
        Drop-outs (percentage)
    3.6
    1.7
    No statistical analyses for this end point

    Secondary: Time to Exit (TTE) during the Evaluation Period

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    End point title
    		 Time to Exit (TTE) during the Evaluation Period
    End point description
    For early termination subjects in the Evaluation period the TTE is the time to discontinuing the study for any reason. TTE was defined as the day of study discontinuation – the day of randomization + 1. For completed subjects, the TTE was censored on Day 6.
    End point type
    Secondary
    End point timeframe
    During Evaluation Period (Day 1 to Day 6)
    End point values
    		 Intent-to-Treat (Placebo treated Subjects) Intent-to-Treat (LEV treated Subjects)
    Number of subjects analysed
    56 [1]
    60 [2]
    Units: Days
    median (confidence interval 95%)
        Median (95 % CI)
    9999 (999 to 99999)
    9999 (999 to 99999)
    Notes
    [1] - 999 / 9999 / 99999 = statistic not estimable
    [2] - 999 / 9999 / 99999 = statistic not estimable
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from Selection Period (Day -8 to Day 0) until Post Treatment Follow-up (Day 24 ± 1).
    Adverse event reporting additional description
    Adverse Events refer to the Intent-to-treat (ITT) Population, including all randomized subjects who took at least one dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 10 % oral solution Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Matching oral solution to Levetiracetam b.i.d. (twice a day) for a maximum treatment duration of 20 days.

    Serious adverse events
    		 Levetiracetam Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 56 (1.79%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Levetiracetam Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 60 (31.67%)
    14 / 56 (25.00%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    8 / 60 (13.33%)
    1 / 56 (1.79%)
         occurrences all number
    8
    1
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    7 / 60 (11.67%)
    0 / 56 (0.00%)
         occurrences all number
    7
    0
    Pyrexia
         subjects affected / exposed
    2 / 60 (3.33%)
    4 / 56 (7.14%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 56 (5.36%)
         occurrences all number
    2
    4
    Vomiting
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 56 (5.36%)
         occurrences all number
    3
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 56 (5.36%)
         occurrences all number
    2
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 56 (5.36%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2004
    Amendment 1 dated 01-Apr-2004 modified the study design to incorporate neuropsychological testing, lengthened the down-titration period to decrease the risk of withdrawal seizures, lengthened the enrollment period and clarified the dosing scheme.
    14 Feb 2005
    Amendment 2 dated 14-Feb-2005 defined the policy regarding the enrollment of infants Born pre-term (before 37 weeks gestational age), defined the minimum weight of 4.0 kg and clarified the requirement for pre-screening of subjects by the UCB Clinical Research Physician (CRP).
    14 Jun 2006
    Amendment 3 dated 14-Jun-2006 added Argentina, Hungary, Poland, Romania and Russia, updated the background information to reflect FDA and European Commission approval of Keppra® for partial onset seizures in children ages four and above, and studies N159 and N157, defined the distinctive difference between electro-clinical seizure and electrographic seizures, and provided clarity to the description of cluster seizures.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/19243423
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