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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam used as add-on Therapy at doses of 0.5 to 3 g/day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)

    Summary
    EudraCT number
    2014-004333-57
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    07 Nov 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N01221
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00280696
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Japan Co., Ltd.
    Sponsor organisation address
    2-2 Kanda-Surugadai, Tokyo, Japan, 101-0062
    Public contact
    CTRRD, UCB Biosciences GmbH, +49 2173481515, clinicaltrials@ucb.com
    Scientific contact
    CTRRD, UCB Biosciences GmbH, +49 2173481515, 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 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the efficacy of levetiracetam (LEV) at doses of 1 and 3 g/day in reducing seizure frequency in patients with partial epilepsy not fully controlled despite treatment with 1 to 3 concomitant Anti-epileptic drugs (AED(s)), and to evaluate the efficacy of LEV at doses of 0.5 and 2 g/day compared to Placebo (PBO).
    Protection of trial subjects
    Not applicable
    Background therapy
    One to three anti-epileptic drug(s)
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    15 Nov 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    54 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 351
    Worldwide total number of subjects
    351
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    26
    Adults (18-64 years)
    325
    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 2005 in Japan.

    Pre-assignment
    Screening details
    Out of 401 screened subjects, 352 subjects were randomized and 351 subjects are included in the Full Analysis Set (FAS) and Safety Set. Subject Disposition refers to the FAS, defined as the set of randomized subjects excluding those who fall under specific pre-defined criteria, like GCP Violation, etc.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind [1]
    Roles blinded
    Carer, Assessor, Subject
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    PBO
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Placebo • Pharmaceutical Form: Film-coated tablet • Concentration: 250 mg and 500 mg • Route of Administration: Oral Use

    Arm title
    Lev 0.5 g
    Arm description
    Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam 250 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 250 mg • Route of Administration: Oral Use

    Arm title
    Lev 1 g
    Arm description
    Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam 250 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 250 mg • Route of Administration: Oral Use

    Investigational medicinal product name
    Levetiracetam 500 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 500 mg • Route of Administration: Oral Use

    Arm title
    Lev 2 g
    Arm description
    Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam 250 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 250 mg • Route of Administration: Oral Use

    Investigational medicinal product name
    Levetiracetam 500 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 500 mg • Route of Administration: Oral Use

    Arm title
    Lev 3 g
    Arm description
    Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).
    Arm type
    Experimental

    Investigational medicinal product name
    Levetiracetam 250 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 250 mg • Route of Administration: Oral Use

    Investigational medicinal product name
    Levetiracetam 500 mg
    Investigational medicinal product code
    Other name
    Keppra
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    • Active Substance: Levetiracetam • Pharmaceutical Form: Film-coated tablet • Concentration: 500 mg • Route of Administration: Oral Use

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Roles blinded: Subject, Caregiver and Outcomes Assessor.
    Number of subjects in period 1
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Started
    70
    71
    70
    70
    70
    Completed
    67
    62
    64
    63
    60
    Not completed
    3
    9
    6
    7
    10
         SAE, non-fatal + AE, non-serious non-fatal
    -
    -
    -
    1
    -
         Protocol deviation
    1
    5
    2
    1
    3
         Lack of efficacy
    -
    -
    2
    1
    1
         Other reason
    -
    1
    -
    -
    -
         SAE, non-fatal
    1
    1
    1
    -
    2
         AE, serious fatal
    -
    -
    -
    -
    1
         AE, non-serious non-fatal
    -
    1
    -
    3
    3
         Consent withdrawn by subject
    1
    1
    1
    -
    -
         Lost to follow-up
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 0.5 g
    Reporting group description
    Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 1 g
    Reporting group description
    Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 2 g
    Reporting group description
    Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 3 g
    Reporting group description
    Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g Total
    Number of subjects
    70 71 70 70 70 351
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    3 5 6 8 4 26
        Adults (18-64 years)
    67 66 64 62 66 325
        From 65-84 years
    0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.89 ± 12.56 33.21 ± 10.64 32.8 ± 10.9 30.44 ± 10.06 33.09 ± 11.72 -
    Gender categorical
    Units: Subjects
        Female
    35 36 41 35 33 180
        Male
    35 35 29 35 37 171
    Hospital Stay
    Units: Subjects
        Inpatient
    1 2 3 2 6 14
        Outpatient
    69 69 67 68 64 337

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 0.5 g
    Reporting group description
    Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 1 g
    Reporting group description
    Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 2 g
    Reporting group description
    Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 3 g
    Reporting group description
    Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Primary: Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period

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    End point title
    Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
    End point description
    The percentage reduction from Baseline in partial seizure frequency per week was calculated with the partial seizure frequency per week over the Evaluation Period (E) and the frequency over the Baseline Period (B) in the following equation: Reduction from Baseline in partial seizure frequency over the Evaluation Period as (%) = (B−E)/B×100
    End point type
    Primary
    End point timeframe
    From Baseline to the 12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    69
    68
    68
    68
    66
    Units: Percent Reduction
        median (inter-quartile range (Q1-Q3))
    12.5 (-5.81 to 31.25)
    12.92 (-13.56 to 41.89)
    18 (-12.25 to 39.91)
    11.11 (-19.64 to 39.09)
    31.67 (0 to 52.07)
    Statistical analysis title
    LEV 1 g vs LEV 3 g vs Placebo
    Statistical analysis description
    Primary analysis related to the confirmation of the efficacy of the LEV doses 1 g and 3 g (doses used in the previous study N165) used a closed-testing procedure. First step: Placebo, LEV 1 g and LEV 3 g were first compared using the Kruskal-Wallis test at 5 % 2-sided significance level. If the comparison was statistically significant, the second step was performed. If p-value was > 5 %, no further inferential Analysis was conducted.
    Comparison groups
    Lev 1 g v Lev 3 g v Placebo
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.067
    Method
    Kruskal-wallis
    Confidence interval
    Statistical analysis title
    LEV 1 g versus Placebo
    Statistical analysis description
    Primary analysis related to the confirmation of the efficacy of the LEV doses 1 g and 3 g (doses used in the previous study N165) used a closed-testing procedure. Second step: Placebo and Lev 1 g were compared using the Wilcoxon Rank-Sum Test at 5 % 2-sided significance level. If the comparison was statistically significant, the last step was performed. If p-value was > 5 %, no further inferential Analysis was conducted.
    Comparison groups
    Placebo v Lev 1 g
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7
    Method
    Wilcoxon Rank-Sum Test
    Parameter type
    Median difference (final values)
    Point estimate
    2.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.23
         upper limit
    14.44
    Statistical analysis title
    LEV 3 g versus Placebo
    Statistical analysis description
    Primary analysis related to the confirmation of the efficacy of the LEV doses 1 g and 3 g (doses used in the previous study N165) used a closed-testing procedure. Last step: Placebo and Lev 3 g were compared using the Wilcoxon Rank Sum Test at 5 % 2-sided significance level.
    Comparison groups
    Placebo v Lev 3 g
    Number of subjects included in analysis
    135
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.025
    Method
    Wilcoxon Rank-Sum Test
    Parameter type
    Median difference (final values)
    Point estimate
    14.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.98
         upper limit
    27.64

    Secondary: Partial (Type I) seizure frequency per week over the Evaluation Period

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    End point title
    Partial (Type I) seizure frequency per week over the Evaluation Period
    End point description
    Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures Complex partial seizures Partial seizures evolving to secondarily generalized seizures.
    End point type
    Secondary
    End point timeframe
    12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    69
    68
    68
    68
    66
    Units: Seizure frequency
        median (inter-quartile range (Q1-Q3))
    2.45 (1.17 to 5.25)
    2.13 (1.13 to 5.21)
    2.33 (1.04 to 4.04)
    2.6 (1.13 to 6.5)
    2 (0.92 to 4.67)
    No statistical analyses for this end point

    Secondary: Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period

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    End point title
    Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period
    End point description
    The percentage of subjects with 50 % or more reduction or with 75 % or more reduction from Baseline in the frequency of partial epileptic seizures during the Evaluation Period is presented below.
    End point type
    Secondary
    End point timeframe
    From Baseline to the 12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    69
    68
    68
    68
    66
    Units: Percentage of subjects
    number (not applicable)
        >= 50 % reduction
    11.6
    19.1
    17.6
    16.2
    33.3
        >= 75 % reduction
    4.3
    5.9
    5.9
    7.4
    10.6
    No statistical analyses for this end point

    Secondary: Seizure freedom over the Evaluation Period

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    End point title
    Seizure freedom over the Evaluation Period
    End point description
    End point type
    Secondary
    End point timeframe
    12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    69
    68
    68
    68
    66
    Units: subjects
    0
    0
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period

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    End point title
    Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period
    End point description
    Percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period was divided into 6 categories: <-25 % -25 % to <25 % 25 % to <50 % 50 % to <75 % 75 % to <100 % 100 %.
    End point type
    Secondary
    End point timeframe
    From Baseline to the 12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    69
    68
    68
    68
    66
    Units: subjects
        <-25 %
    4
    13
    11
    16
    10
        -25 % to <25 %
    43
    28
    30
    28
    20
        25 % to <50 %
    14
    14
    15
    13
    14
        50 % to <75 %
    5
    9
    8
    6
    15
        75 % to <100 %
    3
    4
    2
    3
    5
        100 %
    0
    0
    2
    2
    2
    No statistical analyses for this end point

    Secondary: Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period

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    End point title
    Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period
    End point description
    Percentage reduction from Baseline in seizure frequency per week over the Evaluation Period is presented by the following seizure subtypes: - simple partial seizures (Type IA) - complex partial seizures (Type IB) - secondarily generalized seizures (Type IC) - simple and complex partial seizures (Types IA + IB) - other seizures (all except partial seizures)
    End point type
    Secondary
    End point timeframe
    From Baseline to the 12-week Evaluation Period
    End point values
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Number of subjects analysed
    70 [1]
    71 [2]
    70 [3]
    70 [4]
    70 [5]
    Units: Percentage reduction
    median (inter-quartile range (Q1-Q3))
        simple partial seizures (Type IA)
    27.92 (-33.33 to 25)
    50 (-25 to 83.33)
    22.25 (-23.08 to 80.95)
    29.73 (-8.31 to 69.19)
    42.86 (-14 to 88.89)
        complex partial seizures (Type IB)
    13.77 (-8.9 to 73.86)
    10.1 (-13.55 to 42.65)
    19.38 (-8.78 to 41.52)
    0 (-32.14 to 45.45)
    30 (-13.07 to 63.33)
        secondarily generalized seizures (Type IC)
    37.13 (-9.88 to 38.37)
    42.11 (-27.27 to 81.25)
    85 (16.8 to 100)
    86.84 (45.45 to 100)
    82.35 (2.63 to 100)
        simple & complex partial seizures (Types IA + IB)
    5.97 (0 to 100)
    13.33 (-13.58 to 42.98)
    17.16 (-13.04 to 41.38)
    4.86 (-25.71 to 26.81)
    29.44 (-11.11 to 54.55)
        other seizures (all except partial seizures)
    1.16 (-9.88 to 30)
    0 (0 to 0)
    49.11 (-1.79 to 100)
    100 (100 to 100)
    100 (100 to 100)
    Notes
    [1] - Type IA: n=36, Type IB: n=63, Type IC: n=18, Type IA+IB: n=67, Other types: n=3
    [2] - Type IA: n=33, Type IB: n=62, Type IC: n=21, Type IA+IB: n=67, Other types: n=1
    [3] - Type IA: n=38, Type IB: n=60, Type IC: n=20, Type IA+IB: n=66, Other types: n=2
    [4] - Type IA: n=41, Type IB: n=63, Type IC: n=14, Type IA+IB: n=68, Other types: n=1
    [5] - Type IA: n=41, Type IB: n=61, Type IC: n=21, Type IA+IB: n=66, Other types: n=1
    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 over a 4-week Up-Titration, 12-week Evaluation (fixed dosage), and 4-week Down-Titration or Transition Period.
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set, which is identical to the Full Analysis Set in this study. Full Analysis Set is defined as the set of randomized subjects excluding those who fall under specific pre-defined criteria, like GCP Violation, etc.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 0.5 g
    Reporting group description
    Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 1 g
    Reporting group description
    Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 2 g
    Reporting group description
    Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Reporting group title
    Lev 3 g
    Reporting group description
    Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening).

    Serious adverse events
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 70 (4.29%)
    4 / 71 (5.63%)
    2 / 70 (2.86%)
    1 / 70 (1.43%)
    5 / 70 (7.14%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 70 (0.00%)
    2 / 71 (2.82%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pyoderma
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 71 (1.41%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Lev 0.5 g Lev 1 g Lev 2 g Lev 3 g
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 70 (67.14%)
    51 / 71 (71.83%)
    43 / 70 (61.43%)
    47 / 70 (67.14%)
    49 / 70 (70.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 71 (4.23%)
    3 / 70 (4.29%)
    7 / 70 (10.00%)
    6 / 70 (8.57%)
         occurrences all number
    4
    3
    5
    13
    7
    Excoriation
         subjects affected / exposed
    0 / 70 (0.00%)
    4 / 71 (5.63%)
    3 / 70 (4.29%)
    0 / 70 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    6
    3
    0
    3
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    3 / 70 (4.29%)
    6 / 71 (8.45%)
    3 / 70 (4.29%)
    1 / 70 (1.43%)
    6 / 70 (8.57%)
         occurrences all number
    3
    6
    3
    2
    7
    White blood cell count increased
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 71 (0.00%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    3 / 70 (4.29%)
         occurrences all number
    4
    0
    0
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    3 / 70 (4.29%)
    3 / 71 (4.23%)
    2 / 70 (2.86%)
    4 / 70 (5.71%)
    4 / 70 (5.71%)
         occurrences all number
    6
    3
    2
    4
    6
    Pharyngolaryngeal pain
         subjects affected / exposed
    2 / 70 (2.86%)
    4 / 71 (5.63%)
    4 / 70 (5.71%)
    3 / 70 (4.29%)
    0 / 70 (0.00%)
         occurrences all number
    2
    4
    5
    4
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    7 / 70 (10.00%)
    8 / 71 (11.27%)
    8 / 70 (11.43%)
    12 / 70 (17.14%)
    12 / 70 (17.14%)
         occurrences all number
    7
    8
    9
    14
    12
    Headache
         subjects affected / exposed
    9 / 70 (12.86%)
    6 / 71 (8.45%)
    3 / 70 (4.29%)
    4 / 70 (5.71%)
    7 / 70 (10.00%)
         occurrences all number
    11
    7
    4
    11
    7
    Dizziness
         subjects affected / exposed
    3 / 70 (4.29%)
    8 / 71 (11.27%)
    1 / 70 (1.43%)
    5 / 70 (7.14%)
    4 / 70 (5.71%)
         occurrences all number
    3
    8
    1
    9
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 70 (5.71%)
    8 / 71 (11.27%)
    4 / 70 (5.71%)
    2 / 70 (2.86%)
    1 / 70 (1.43%)
         occurrences all number
    6
    13
    6
    2
    1
    Constipation
         subjects affected / exposed
    1 / 70 (1.43%)
    2 / 71 (2.82%)
    2 / 70 (2.86%)
    1 / 70 (1.43%)
    4 / 70 (5.71%)
         occurrences all number
    1
    2
    2
    1
    4
    Abdominal pain
         subjects affected / exposed
    5 / 70 (7.14%)
    4 / 71 (5.63%)
    0 / 70 (0.00%)
    1 / 70 (1.43%)
    0 / 70 (0.00%)
         occurrences all number
    5
    10
    0
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    24 / 70 (34.29%)
    24 / 71 (33.80%)
    26 / 70 (37.14%)
    25 / 70 (35.71%)
    28 / 70 (40.00%)
         occurrences all number
    34
    36
    35
    46
    45
    Gastroenteritis
         subjects affected / exposed
    2 / 70 (2.86%)
    4 / 71 (5.63%)
    1 / 70 (1.43%)
    2 / 70 (2.86%)
    2 / 70 (2.86%)
         occurrences all number
    2
    4
    1
    2
    2
    Dental caries
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 71 (0.00%)
    4 / 70 (5.71%)
    1 / 70 (1.43%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    4
    1
    1

    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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