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    Clinical Trial Results:
    HEAD-TO-HEAD evaluation of the antiepileptic drugs Levetiracetam (LEV) vs. Sulthiame (STM) in a German multi-centre, doubleblind controlled trial in children with benign epilepsy with centro-temporal spikes

    Summary
    EudraCT number
    		 2005-004468-22
    Trial protocol
    		 DE  
    Global end of trial date
    01 Oct 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Sep 2021
    First version publication date
    02 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HEAD-STUDIE
    Additional study identifiers
    ISRCTN number
    		 ISRCTN97864911
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. von Haunersches Kinderspital München
    Sponsor organisation address
    Lindwurmstr. 4, Munich, Germany, 80337
    Public contact
    Dr. von Haunersches Kinderspital München, Dr. von Haunersches Kinderspital München, 89 440052811,
    Scientific contact
    Dr. von Haunersches Kinderspital München, Dr. von Haunersches Kinderspital München, 49 89440052811,
    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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the HEAD-STUDIE is to evaluate the efficacy of levetiracetam in the treatment of children with BECTS compared to sulthiame
    Protection of trial subjects
    Routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2006
    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
    Germany: 44
    Worldwide total number of subjects
    44
    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)
    0
    Children (2-11 years)
    44
    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
    		 47 German study centers

    Pre-assignment
    Screening details
    		 Screening for 28 days

    Period 1
    Period 1 title
    Dosage adjustment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levetiracetam
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    Dosage increase to 30 mg/kg*d

    Arm title
    		 Sulthiame
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulthiame
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    6 mg/kg*d

    Number of subjects in period 1
    		Levetiracetam Sulthiame
    Started
    22
    22
    Completed
    22
    22
    Period 2
    Period 2 title
    Observation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levetiracetam
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    Dosage increase to 30 mg/kg*d

    Arm title
    		 Sulthiame
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sulthiame
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    6 mg/kg*d

    Number of subjects in period 2
    		Levetiracetam Sulthiame
    Started
    22
    22
    Completed
    13
    19
    Not completed
    9
    3
         Adverse event, non-fatal
    5
    1
         Lack of efficacy
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dosage adjustment
    Reporting group description
    		 -

    Reporting group values
    		 Dosage adjustment Total
    Number of subjects
    		 44 44
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 44 44
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 28 28

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 -

    Reporting group title
    Sulthiame
    Reporting group description
    		 -
    Reporting group title
    Levetiracetam
    Reporting group description
    		 -

    Reporting group title
    Sulthiame
    Reporting group description
    		 -

    Primary: Treatment failure

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    End point title
    		 Treatment failure
    End point description
    End point type
    Primary
    End point timeframe
    Observation period
    End point values
    		 Levetiracetam Sulthiame
    Number of subjects analysed
    22
    22
    Units: Patients
    4
    2
    Statistical analysis title
    		 Treatment failure
    Comparison groups
    Levetiracetam v Sulthiame
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.412
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Dropout due to adverse events

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    End point title
    		 Dropout due to adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Observation period
    End point values
    		 Levetiracetam Sulthiame
    Number of subjects analysed
    22
    22
    Units: Patients
    5
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Whole study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Custom
    Dictionary version
    x
    Reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 -

    Reporting group title
    Sulthiame
    Reporting group description
    		 -

    Serious adverse events
    		 Levetiracetam Sulthiame
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Psychiatric disorders
    Suicidal thoughts
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Levetiracetam Sulthiame
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    22 / 22 (100.00%)
    Cardiac disorders
    Cardiac
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    Nervous system disorders
    CNS
         subjects affected / exposed
    13 / 22 (59.09%)
    16 / 22 (72.73%)
         occurrences all number
    13
    16
    General disorders and administration site conditions
    General
         subjects affected / exposed
    15 / 22 (68.18%)
    17 / 22 (77.27%)
         occurrences all number
    15
    17
    Other
         subjects affected / exposed
    4 / 22 (18.18%)
    5 / 22 (22.73%)
         occurrences all number
    4
    5
    Gastrointestinal disorders
    Gastrointestinal
         subjects affected / exposed
    10 / 22 (45.45%)
    8 / 22 (36.36%)
         occurrences all number
    10
    8
    Respiratory, thoracic and mediastinal disorders
    Airways
         subjects affected / exposed
    5 / 22 (22.73%)
    14 / 22 (63.64%)
         occurrences all number
    5
    14
    Psychiatric disorders
    Behavior
         subjects affected / exposed
    13 / 22 (59.09%)
    13 / 22 (59.09%)
         occurrences all number
    22
    22
    Musculoskeletal and connective tissue disorders
    Bones and muscles
         subjects affected / exposed
    4 / 22 (18.18%)
    4 / 22 (18.18%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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