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    Clinical Trial Results:
    An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures

    Summary
    EudraCT number
    		 2014-004377-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N01375
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01506882
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Japan Co. Ltd.
    Sponsor organisation address
    8-17-1 Nishi-Shinjuku, Tokyo, Japan, 160-0023
    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
    21 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of LEV used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
    Protection of trial subjects
    N01375 was continued until the Ministry of Health, Labor and Welfare (Japan) approved the use of Levetiracetam (LEV) monotherapy for Partial Onset Seizures (POS) in adults and until all subjects who were taking LEV as investigational medicinal product (IMP) had a the option to switch to commercial LEV in Japan. Antidepressant use was allowed if the medication and dose were stable for at least 6 months prior to Visit 1 and the medication and dose were to be kept stable for the entire study duration. The following medications were used as rescue medications at the investigator’s discretion to maintain the subject’s safety: - Diazepam (suppository, injection) - Phenobarbital sodium (suppository, injection) - Chloral hydrate (enema preparation, suppository) - Phenytoin sodium (injection) - Fosphenytoin sodium hydrate (injection)
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Based on the controlled studies that evaluated Anti-Epileptic Drugs (AEDs) in the past, the magnitude of the clinical effects of conventional AEDs as the percentage of subjects who achieved 6-month seizure freedom was expected to be approximately 50 % in subjects with newly or recently diagnosed Partial Onset Seizures (POS).The ILAE Treatment Guidelines (Glauser, 2006) stated that non-inferiority outcomes with any relative difference >20 % in the efficacy evaluation had to be regarded as clinically important. According to this, a threshold level of 40 % (50 % − 0.2 × 50 %) in efficacy of Levetiracetam (LEV) monotherapy was defined for the percentage of the subjects who would achieve seizure freedom for 6 months by detecting the statistically significant difference between the defined threshold level and the study result to be obtained. The primary efficacy evaluation was to be performed on the LEV 1000 mg/day to 2000 mg/day groups.
    Actual start date of recruitment
    15 Dec 2011
    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
    Japan: 71
    Worldwide total number of subjects
    71
    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)
    6
    Adults (18-64 years)
    58
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter study started to enroll subjects in December 2011 in order to end up with 27 centers with enrolled subjects in Japan.

    Pre-assignment
    Screening details
    		 Participant Flow refers to the Randomized Set (RS). RS consists of all subjects who were randomized to the study groups.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levetiracetam 1000 mg/day to 2000 mg/day group
    Arm description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.- Frequency: Twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra, E 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 and 500 mg - Route of Administration: Oral use

    Arm title
    		 Levetiracetam 3000 mg/day group
    Arm description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. - Frequency: Twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levetiracetam
    Investigational medicinal product code
    ucb L059
    Other name
    Keppra, E 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 and 500 mg - Route of Administration: Oral use

    Number of subjects in period 1
    		Levetiracetam 1000 mg/day to 2000 mg/day group Levetiracetam 3000 mg/day group
    Started
    61
    10
    Completed
    39
    3
    Not completed
    22
    7
         Consent withdrawn by subject
    9
    3
         AE, non-serious non-fatal
    3
    1
         Other Reason
    2
    -
         Lost to follow-up
    1
    -
         SAE, non-fatal
    2
    -
         Lack of efficacy
    4
    3
         SAE, non-fatal + AE, non-serious non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam 1000 mg/day to 2000 mg/day group
    Reporting group description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.- Frequency: Twice daily

    Reporting group title
    Levetiracetam 3000 mg/day group
    Reporting group description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. - Frequency: Twice daily

    Reporting group values
    		 Levetiracetam 1000 mg/day to 2000 mg/day group Levetiracetam 3000 mg/day group Total
    Number of subjects
    		 61 10 71
    Age Categorical
    Units: Subjects
        <=18 years
    		 10 1 11
        Between 18 and 65 years
    		 45 8 53
        >=65 years
    		 6 1 7
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.5 ± 18 37 ± 18.6 -
    Gender Categorical
    Units: Subjects
        Female
    		 34 4 38
        Male
    		 27 6 33
    Region of Enrollment
    Units: Subjects
        Japan
    		 61 10 71
    Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    		 58.98 ± 12.3 62.58 ± 15.11 -
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    		 161.96 ± 8.77 166.07 ± 10.21 -

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam 1000 mg/day to 2000 mg/day group
    Reporting group description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.- Frequency: Twice daily

    Reporting group title
    Levetiracetam 3000 mg/day group
    Reporting group description
    		 - Formulation: Tablet- Strength: LEV 250 mg, LEV 500 mg- Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. - Frequency: Twice daily

    Subject analysis set title
    Full Analysis Set (LEV 1000 mg/day to 2000 mg/day group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. - Formulation: Tablet - Strength: LEV 250 mg, LEV 500 mg - Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. - Frequency: Twice daily

    Subject analysis set title
    Full Analysis Set (LEV 3000 mg/day group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose. - Formulation: Tablet - Strength: LEV 250 mg, LEV 500 mg - Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. - Frequency: Twice daily

    Primary: Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period

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    End point title
    		 Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period [1]
    End point description
    A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free: - A documented seizure during 6 consecutive months of the Evaluation Analysis Period - Subject discontinued the study prematurely during the Evaluation Analysis Period - Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
    End point type
    Primary
    End point timeframe
    From the end of the 1-week Stabilization Period over the 26-weeks 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: Values presented below are from the statistical analysis of this Primary Endpoint. The lower limit of the two-sided 95% CI for the estimate of Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period, 60.9%, was greater than the reference value 40%.
    End point values
    		 Levetiracetam 1000 mg/day to 2000 mg/day group Levetiracetam 3000 mg/day group
    Number of subjects analysed
    61
    0 [2]
    Units: percentage of participants
    number (confidence interval 95%)
        percentage of participants
    73.8 (60.9 to 84.2)
    ( to )
    Notes
    [2] - Primary Efficacy analysis was conducted for the 1000 mg/day - 2000 mg/day group only
    No statistical analyses for this end point

    Secondary: Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period

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    End point title
    		 Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period
    End point description
    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
    End point type
    Secondary
    End point timeframe
    From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
    End point values
    		 Full Analysis Set (LEV 1000 mg/day to 2000 mg/day group)
    Number of subjects analysed
    61
    Units: percentage of participants
    number (confidence interval 95%)
        percentage of participants
    59 (45.7 to 71.4)
    No statistical analyses for this end point

    Secondary: Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period

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    End point title
    		 Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period [3]
    End point description
    A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free: - A documented seizure during 6 consecutive months of the Evaluation Analysis Period - Subject discontinued the study prematurely during the Evaluation Analysis Period - Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
    End point type
    Secondary
    End point timeframe
    From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics for the 1000 mg/day to 2000 mg/day group are not reported here as this group was not part of this secondary Endpoint.
    End point values
    		 Levetiracetam 3000 mg/day group
    Number of subjects analysed
    9
    Units: percentage of participants
    number (confidence interval 95%)
        percentage of participants
    22.2 (2.8 to 60)
    No statistical analyses for this end point

    Secondary: Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period

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    End point title
    		 Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period
    End point description
    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
    End point type
    Secondary
    End point timeframe
    From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
    End point values
    		 Full Analysis Set (LEV 3000 mg/day group)
    Number of subjects analysed
    9
    Units: percentage of participants
    number (confidence interval 95%)
        percentage of participants
    11.1 (0.3 to 48.2)
    No statistical analyses for this end point

    Secondary: Time to first seizure at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group

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    End point title
    		 Time to first seizure at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group
    End point description
    Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve.
    End point type
    Secondary
    End point timeframe
    During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
    End point values
    		 Full Analysis Set (LEV 1000 mg/day to 2000 mg/day group)
    Number of subjects analysed
    61 [4]
    Units: days
    median (confidence interval 95%)
        Median Time to First Seizure (95 % CI)
    999 (359 to 9999)
    Notes
    [4] - 999/9999= Median Time and upper limit of the 95 % CI were not estimable.
    No statistical analyses for this end point

    Secondary: Time to withdrawal at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group

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    End point title
    		 Time to withdrawal at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group
    End point description
    Median time to withdrawal will be estimated from the Kaplan-Meier curve.
    End point type
    Secondary
    End point timeframe
    During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
    End point values
    		 Full Analysis Set (LEV 1000 mg/day to 2000 mg/day group)
    Number of subjects analysed
    61 [5]
    Units: days
    median (confidence interval 95%)
        Median Time to Withdrawal (95 % CI)
    999 (99 to 9999)
    Notes
    [5] - 99/999/9999= Median Time and upper and lower limit of the 95 % CI were not estimable.
    No statistical analyses for this end point

    Secondary: Time to first seizure in subjects in the Levetiracetam (LEV) 3000 mg/day group

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    End point title
    		 Time to first seizure in subjects in the Levetiracetam (LEV) 3000 mg/day group
    End point description
    Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered. The Median time to first seizure will be estimated from the Kaplan-Meier curve.
    End point type
    Secondary
    End point timeframe
    During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
    End point values
    		 Full Analysis Set (LEV 3000 mg/day group)
    Number of subjects analysed
    9 [6]
    Units: days
    median (confidence interval 95%)
        Median Time to First Seizure (95 % CI)
    106 (9 to 999)
    Notes
    [6] - 999= Upper limit of the 95 % CI was not estimable.
    No statistical analyses for this end point

    Secondary: Time to withdrawal in subjects in the Levetiracetam (LEV) 3000 mg/day group

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    End point title
    		 Time to withdrawal in subjects in the Levetiracetam (LEV) 3000 mg/day group [7]
    End point description
    Median time to withdrawal will be estimated from the Kaplan-Meier curve.
    End point type
    Secondary
    End point timeframe
    During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistics for the 1000 mg/day to 2000 mg/day group are not reported here as this group was not part of this secondary Endpoint.
    End point values
    		 Levetiracetam 3000 mg/day group
    Number of subjects analysed
    9
    Units: days
    median (confidence interval 95%)
        Median Time to Withdrawal (95 % CI)
    91 (21 to 197)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent Adverse Events were collected from Screening (Week 0) over the Evaluation and Maintenance Period (Week 4 to Week 53) until the last Follow-up Visit or Withdrawal Visit.
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set including all subjects in the Enrolled Set who received at least 1 dose of the Investigational Medicinal Product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Levetiracetam 1000 mg/day to 2000 mg/day group
    Reporting group description
    		 - Formulation: Tablet - Strength: LEV 250 mg, LEV 500 mg - Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day. - Frequency: Twice daily

    Reporting group title
    Levetiracetam 3000 mg/day group
    Reporting group description
    		 - Formulation: Tablet - Strength: LEV 250 mg, LEV 500 mg - Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial. - Frequency: Twice daily

    Serious adverse events
    		 Levetiracetam 1000 mg/day to 2000 mg/day group Levetiracetam 3000 mg/day group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 61 (13.11%)
    2 / 10 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Meniscus removal
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Status epilepticus
         subjects affected / exposed
    3 / 61 (4.92%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal state
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (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
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal psychosis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kaposi's varicelliform eruption
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Levetiracetam 1000 mg/day to 2000 mg/day group Levetiracetam 3000 mg/day group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 61 (95.08%)
    10 / 10 (100.00%)
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    12 / 61 (19.67%)
    0 / 10 (0.00%)
         occurrences all number
    13
    0
    Pyrexia
         subjects affected / exposed
    5 / 61 (8.20%)
    1 / 10 (10.00%)
         occurrences all number
    6
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    5 / 61 (8.20%)
    0 / 10 (0.00%)
         occurrences all number
    8
    0
    Acquired phimosis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 61 (8.20%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    3
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Investigations
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Weight increased
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 10 (20.00%)
         occurrences all number
    2
    2
    Urine ketone body present
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Blood urine present
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    5 / 61 (8.20%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Head injury
         subjects affected / exposed
    1 / 61 (1.64%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Ligament sprain
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Arthropod sting
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mouth injury
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    25 / 61 (40.98%)
    2 / 10 (20.00%)
         occurrences all number
    32
    2
    Dizziness
         subjects affected / exposed
    8 / 61 (13.11%)
    1 / 10 (10.00%)
         occurrences all number
    9
    1
    Headache
         subjects affected / exposed
    10 / 61 (16.39%)
    1 / 10 (10.00%)
         occurrences all number
    14
    1
    Dizziness postural
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Amnestic disorder
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 61 (13.11%)
    2 / 10 (20.00%)
         occurrences all number
    18
    2
    Nausea
         subjects affected / exposed
    6 / 61 (9.84%)
    1 / 10 (10.00%)
         occurrences all number
    14
    1
    Dental caries
         subjects affected / exposed
    6 / 61 (9.84%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Abdominal discomfort
         subjects affected / exposed
    4 / 61 (6.56%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Abdominal pain upper
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 10 (0.00%)
         occurrences all number
    17
    0
    Gastritis
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Lip ulceration
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    2
    Dry skin
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Ketonuria
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 61 (9.84%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    47 / 61 (77.05%)
    4 / 10 (40.00%)
         occurrences all number
    155
    7
    Influenza
         subjects affected / exposed
    7 / 61 (11.48%)
    0 / 10 (0.00%)
         occurrences all number
    8
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Cystitis
         subjects affected / exposed
    4 / 61 (6.56%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Gingivitis
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    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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    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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