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    Clinical Trial Results:
    An open-label, multicenter, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV) (oral tablets of 166, 250 or 500 mg b.i.d.), at individualized doses up to a maximum of 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures

    Summary
    EudraCT number
    2004-001997-13
    Trial protocol
    AT   EE  
    Global end of trial date
    10 Jul 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N167
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00150748
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma SA
    Sponsor organisation address
    Chemin du Foriest, Braine l’Alleud, Belgium, B - 1420
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 4815 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
    14 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of N167 was to evaluate the safety and efficacy of LEV at individualized doses with a maximum dose of 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg), in reducing seizures in children, adolescents, and adults suffering from Primary generalized (type II) seizures.
    Protection of trial subjects
    Not applicable
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Nov 2001
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 38
    Country: Number of subjects enrolled
    Estonia: 5
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Mexico: 46
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Poland: 41
    Country: Number of subjects enrolled
    Russian Federation: 21
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    United States: 21
    Worldwide total number of subjects
    237
    EEA total number of subjects
    103
    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)
    10
    Adolescents (12-17 years)
    23
    Adults (18-64 years)
    204
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study started to enroll subjects in November 2001. 217 subjects were enrolled from studies N01057 and N166, which are defined as the ITT Population, and 20 subjects ere enrolled from studies N129 and N164.

    Pre-assignment
    Screening details
    Participant Flow shows all enrolled subjects.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Levetiracetam (subjects from N01057 and N166)
    Arm description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All subjects received open-label Levetiracetam during this study. Investigational product consisted of film-coated tablets of 166, 250, or 500 mg Levetiracetam to be taken orally with or without food.

    Arm title
    Levetiracetam (subjects from N129 and N164)
    Arm description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All subjects received open-label Levetiracetam during this study. Investigational product consisted of film-coated tablets of 166, 250, or 500 mg Levetiracetam to be taken orally with or without food.

    Number of subjects in period 1
    Levetiracetam (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164)
    Started
    217
    20
    Completed
    125
    3
    Not completed
    92
    17
         Other Reason
             20
             11
         Protocol deviation
             3
             1
         Loss of efficacy
             2
             -
         Lack of efficacy
             26
             -
         SAE, non-fatal
             10
             -
         AE, serious fatal
             1
             -
         AE, non-serious non-fatal
             9
             -
         Consent withdrawn by subject
             11
             3
         Lost to follow-up
             10
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam (subjects from N01057 and N166)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Reporting group title
    Levetiracetam (subjects from N129 and N164)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Reporting group values
    Levetiracetam (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164) Total
    Number of subjects
    217 20 237
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    7 3 10
        Adolescents (12-17 years)
    23 0 23
        Adults (18-64 years)
    187 17 204
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    27.99 ± 10.88 31.1 ± 12.28 -
    Gender Categorical
    Units: Subjects
        Male
    91 9 100
        Female
    126 11 137

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam (subjects from N01057 and N166)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Reporting group title
    Levetiracetam (subjects from N129 and N164)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Subject analysis set title
    Myoclonic subpopulation
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Any N166/N01057 ITT subject with Myoclonic seizure days per week >0 at N166 (prospective) or N01057 (combined) Baseline.

    Subject analysis set title
    All intent-to-treat (ITT) population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The All intent-to-treat (ITT) Population was defined as all subjects coming from study N01057 or N166 who had recorded intake of at least 1 dose of N167 study medication.

    Subject analysis set title
    Tonic-Clonic subpopulation
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Any N166/N01057 ITT subject with a Tonic-Clonic seizure frequency per week >0 at N166 (prospective) or N01057 (combined) Baseline.

    Subject analysis set title
    Absence subpopulation
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Any N166/N01057 ITT subject with a IIA seizure days per week >0 at N166 (prospective) or N01057 (combined) Baseline.

    Primary: Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

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    End point title
    Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [1]
    End point description
    End point type
    Primary
    End point timeframe
    Evaluation Period
    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
    Levetiracetam (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164)
    Number of subjects analysed
    217
    20
    Units: Subjects
        Number of subjects
    122
    12
    No statistical analyses for this end point

    Primary: Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

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    End point title
    Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [2]
    End point description
    End point type
    Primary
    End point timeframe
    Evaluation Period
    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
    Levetiracetam (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164)
    Number of subjects analysed
    217
    20
    Units: Percentage of subjects
    number (not applicable)
        percentage of subjects
    56.2
    60
    No statistical analyses for this end point

    Secondary: Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

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    End point title
    Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
    End point description
    End point type
    Secondary
    End point timeframe
    From Visit 1 to the end of the Evaluation Period
    End point values
    All intent-to-treat (ITT) population Tonic-Clonic subpopulation Myoclonic subpopulation Absence subpopulation
    Number of subjects analysed
    217
    152
    121
    70
    Units: Subjects
        Number of seizure-free subjects
    49
    42
    33
    24
    No statistical analyses for this end point

    Secondary: Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

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    End point title
    Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period
    End point description
    End point type
    Secondary
    End point timeframe
    From Visit 1 to the end of the Evaluation Period
    End point values
    All intent-to-treat (ITT) population Tonic-Clonic subpopulation Myoclonic subpopulation Absence subpopulation
    Number of subjects analysed
    217
    152
    121
    70
    Units: Percentage of subjects
    number (not applicable)
        Percentage of seizure-free subjects
    22.6
    27.6
    27.3
    34.3
    No statistical analyses for this end point

    Secondary: Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

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    End point title
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    End point description
    A positive value for Reduction of seizure frequency indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From N01057 or N166 Baseline to the Evaluation Period
    End point values
    Tonic-Clonic subpopulation
    Number of subjects analysed
    152
    Units: Reduction of Seizure Frequency
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    0.8 ± 1.51
    No statistical analyses for this end point

    Secondary: Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

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    End point title
    Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    End point description
    A positive value for Percentage reduction of seizure frequency indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From N01057 or N166 Baseline to the Evaluation Period
    End point values
    Tonic-Clonic subpopulation
    Number of subjects analysed
    152
    Units: Percentage of Seizure Frequency
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    66.84 ± 88.31
    No statistical analyses for this end point

    Secondary: Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

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    End point title
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    End point description
    A positive value for Reduction of seizure days per week indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From N01057 or N166 Baseline to the Evaluation Period
    End point values
    All intent-to-treat (ITT) population Myoclonic subpopulation Absence subpopulation
    Number of subjects analysed
    217
    121
    70
    Units: Reduction of Seizure Days
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    1.44 ± 1.69
    1.48 ± 1.69
    1.31 ± 2.24
    No statistical analyses for this end point

    Secondary: Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

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    End point title
    Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    End point description
    A positive value for Percentage reduction of seizure days per week indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From N01057 or N166 Baseline to the Evaluation Period
    End point values
    All intent-to-treat (ITT) population Myoclonic subpopulation Absence subpopulation
    Number of subjects analysed
    217
    121
    70
    Units: Percentage reduction of Seizure Days
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    73.06 ± 39.62
    71.67 ± 70.58
    60.13 ± 72.26
    No statistical analyses for this end point

    Secondary: Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

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    End point title
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluation Period
    End point values
    All intent-to-treat (ITT) population Myoclonic subpopulation Absence subpopulation
    Number of subjects analysed
    217
    121
    70
    Units: Subjects
        < -25 %
    8
    6
    8
        -25 % to < 25 %
    12
    6
    3
        25 % to < 50 %
    24
    7
    6
        50 % to < 75 %
    32
    13
    6
        75 % to < 100 %
    89
    51
    18
        100 %
    52
    38
    29
    No statistical analyses for this end point

    Secondary: Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

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    End point title
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    End point description
    End point type
    Secondary
    End point timeframe
    Evaluation Period
    End point values
    Tonic-Clonic subpopulation
    Number of subjects analysed
    152
    Units: Subjects
        < - 25 %
    4
        -25 % to < 25 %
    10
        25 % to < 50 %
    12
        50 % to < 75 %
    33
        75 % to < 100 %
    48
        100 %
    45
    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 Visit 1 (Week 0) until the end of study (up to 1764 days).
    Adverse event reporting additional description
    Adverse Events refer to the Intent-to-Treat (ITT) Population, including all subjects who had recorded intake of at least 1 dose of N167 study drug.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.0
    Reporting groups
    Reporting group title
    Levetiracetam (subjects from N01057 and N166)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Reporting group title
    Levetiracetam (subjects from N129 and N164)
    Reporting group description
    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Serious adverse events
    Levetiracetam (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 217 (14.29%)
    4 / 20 (20.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    7 / 217 (3.23%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    2 / 217 (0.92%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    2 / 217 (0.92%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    4 / 217 (1.84%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unintended pregnancy
         subjects affected / exposed
    2 / 217 (0.92%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-uterine death
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ failure
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash erythematous
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (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
    Appendicitis
         subjects affected / exposed
    1 / 217 (0.46%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 217 (0.00%)
    1 / 20 (5.00%)
         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 (subjects from N01057 and N166) Levetiracetam (subjects from N129 and N164)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 217 (48.85%)
    16 / 20 (80.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Investigations
    Weight increased
         subjects affected / exposed
    17 / 217 (7.83%)
    2 / 20 (10.00%)
         occurrences all number
    17
    2
    Respiratory, thoracic and mediastinal disorders
    Sinus pain
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 217 (0.00%)
    5 / 20 (25.00%)
         occurrences all number
    0
    5
    Headache
         subjects affected / exposed
    40 / 217 (18.43%)
    2 / 20 (10.00%)
         occurrences all number
    93
    5
    Tremor
         subjects affected / exposed
    15 / 217 (6.91%)
    0 / 20 (0.00%)
         occurrences all number
    17
    0
    Dizziness
         subjects affected / exposed
    18 / 217 (8.29%)
    2 / 20 (10.00%)
         occurrences all number
    25
    2
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    15 / 217 (6.91%)
    0 / 20 (0.00%)
         occurrences all number
    16
    0
    Stress symptoms
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    13 / 217 (5.99%)
    0 / 20 (0.00%)
         occurrences all number
    15
    0
    Diarrhoea
         subjects affected / exposed
    0 / 217 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    6
    Constipation
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    4
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    24 / 217 (11.06%)
    2 / 20 (10.00%)
         occurrences all number
    43
    2
    Influenza
         subjects affected / exposed
    20 / 217 (9.22%)
    2 / 20 (10.00%)
         occurrences all number
    30
    2
    Ear infection
         subjects affected / exposed
    0 / 217 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    13 / 217 (5.99%)
    2 / 20 (10.00%)
         occurrences all number
    16
    3
    Bronchitis
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 217 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    5
    Gastroenteritis
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 217 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Sep 2003
    The core protocol amendment was issued on 08 Sep 2003 and concerned the following: • The number of participating sites and countries was extended due to a delay in recruitment in the prior N166 and N01057 studies. • Adverse events reported in postmarketing experience were added to protocol Section 2.2.4, Adverse Events in Clinical Studies (Section 16.1.1). • Some administrative changes were made to the protocol that did not alter the conduct of the study (eg, emergency contacts were updated and various edits made to sentences for clarification only).

    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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