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    Clinical Trial Results:
    A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study

    Summary
    EudraCT number
    		 2014-004334-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Dec 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    N01222
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00367432
    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, 0049 2173 4815 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 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
    03 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to continuously evaluate the safety of long-term administration at the dose range from LEV 500 mg/day to LEV 3000 mg/day in subjects who completed N01221 or N01020.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    12 Jul 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 398
    Worldwide total number of subjects
    398
    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)
    19
    Adults (18-64 years)
    379
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The Full Analysis Set (FAS) includes all subjects to whom the investigational products are assigned after registration, excluding those with serious Good Clinical Practice violations , subjects not administered the investigational products and subjects for whom no data is available after assignment of the investigational products.

    Pre-assignment
    Screening details
    		 Eligible subjects from preceding study N01221 [NCT00280696] entered the First Period of this study and those subjects from N01221 [NCT00280696] who completed the First Period and subjects from the study N01020 [NCT00160615] entered the Second Period. Participant Flow refers to the FAS.

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

    Arms
    Arm title
    		 Levetiracetam
    Arm description
    		 Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
    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
    Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

    Number of subjects in period 1
    		Levetiracetam
    Started
    398
    Completed
    257
    Not completed
    141
         AE, serious fatal
    3
         Consent withdrawn by subject
    19
         Other Reason
    10
         AE, non-serious non-fatal
    14
         Lost to follow-up
    1
         SAE, non-fatal
    6
         Lack of efficacy
    88

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

    Reporting group values
    		 Levetiracetam Total
    Number of subjects
    		 398 398
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 19 19
        Adults (18-64 years)
    		 379 379
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.68 ( 11.18 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 196 196
        Male
    		 202 202
    Race/Ethnicity, Customized
    Units: Subjects
        Japanese
    		 396 396
        Asian (other than Japanese)
    		 2 2
    Region of Enrollment
    Units: Subjects
        Japan
    		 398 398
    Weight
    Units: Kilogram (kg)
        arithmetic mean (standard deviation)
    		 60.39 ( 13.64 ) -

    End points

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    End points reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

    Primary: Occurrence of treatment-emergent adverse events during the study period (until the time of approval granted)

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    End point title
    		 Occurrence of treatment-emergent adverse events during the study period (until the time of approval granted) [1]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
    End point type
    Primary
    End point timeframe
    During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted
    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: There was no statistical analysis for this endpoint in this open-label study.
    End point values
    		 Levetiracetam
    Number of subjects analysed
    398
    Units: participants
        number
    381
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in partial (type 1) seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in partial (type 1) seizure frequency per week during the first 16-week period in this study
    End point description
    The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as: [ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. 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
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    313
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    22 (-11 to 46.71)
    No statistical analyses for this end point

    Secondary: Seizure frequency per week in partial seizures during the first 16-week period in this study

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    End point title
    		 Seizure frequency per week in partial seizures during the first 16-week period in this study
    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
    First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)
    End point values
    		 Levetiracetam
    Number of subjects analysed
    313
    Units: Seizures Per Week
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    2.13 (1.06 to 5.23)
    No statistical analyses for this end point

    Secondary: Response status (patients with a percent reduction in partial seizure frequency of at least 50% During the First 16-week Period in This Study From Baseline in N01221)

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    End point title
    		 Response status (patients with a percent reduction in partial seizure frequency of at least 50% During the First 16-week Period in This Study From Baseline in N01221)
    End point description
    The percent reduction from Baseline was computed as: [ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100. Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week. 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
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    313
    Units: Participants
        Responders
    74
        Non-responders
    239
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in simple partial seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in simple partial seizure frequency per week during the first 16-week period in this study
    End point description
    Change in simple partial seizure frequency is given as a percent reduction computed as: [ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. 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
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    173
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    39.84 (-17.19 to 94.96)
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in complex partial seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in complex partial seizure frequency per week during the first 16-week period in this study
    End point description
    Change in complex partial seizure frequency is given as a percent reduction computed as: [ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. 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
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    285
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    20.59 (-15.24 to 52.94)
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in secondary generalized seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in secondary generalized seizure frequency per week during the first 16-week period in this study
    End point description
    Change in secondary generalized seizure frequency is given as a percent reduction computed as: [ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. Secondary generalized seizures belong to one of the 3 groups: - Simple partial sz evolving to gen sz - Complex partial sz evolving to gen sz - Simple partial sz evolving to Complex partial sz evolving to gen sz
    End point type
    Secondary
    End point timeframe
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    87
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    76.56 (23.11 to 100)
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in simple and complex partial seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in simple and complex partial seizure frequency per week during the first 16-week period in this study
    End point description
    Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A): [ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. 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
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    308
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    20.71 (-13.17 to 47.42)
    No statistical analyses for this end point

    Secondary: Change from Baseline in N01221 [NCT00280696] in other types of seizure frequency per week during the first 16-week period in this study

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    End point title
    		 Change from Baseline in N01221 [NCT00280696] in other types of seizure frequency per week during the first 16-week period in this study
    End point description
    Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B): [ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Other types of Seizures are all seizures except Partial Seizures (Type 1).
    End point type
    Secondary
    End point timeframe
    Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
    End point values
    		 Levetiracetam
    Number of subjects analysed
    5
    Units: Percent Reduction
    median (inter-quartile range (Q1-Q3))
        median (inter-quartile-range)
    66.47 (7.48 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected up to 60 months from Visit 1 (Week 0) over the First and Second Period until Down-titration and Follow up.
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set (SS). SS includes all subjects from studies N01221 [NCT00280696] and N01020 [NCT00160615] administered the investigational products at least once.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Levetiracetam
    Reporting group description
    		 Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

    Serious adverse events
    		 Levetiracetam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    64 / 398 (16.08%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small Intestine Carcinoma
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Abortion Induced
         subjects affected / exposed
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Brain Operation
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Medical Diet
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wisdom Teeth Removal
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Complete
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sudden Unexplained Death in Epilepsy
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Lactation Disorder
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Choking
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pneumonia Aspiration
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Acute Psychosis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ideas of Reference
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental Disorder
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Morose
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Anticonvulsant Drug Level Increased
         subjects affected / exposed
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Electrocardiogram ST Segment Elevation
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Anticonvulsant Toxicity
         subjects affected / exposed
    3 / 398 (0.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Patella Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin Laceration
         subjects affected / exposed
    3 / 398 (0.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Skull Fracture
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral Infarction
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Complex Partial Seizures
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug Withdrawal Convulsions
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    5 / 398 (1.26%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Head Titubation
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postictal State
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    5 / 398 (1.26%)
         occurrences causally related to treatment / all
    5 / 9
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Eyelid Ptosis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colonic Polyp
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urethral Stenosis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaw Disorder
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis Escherichia Coli
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infected Epidermal Cyst
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injection Site Infection
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 398 (1.01%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Mycoplasmal
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Levetiracetam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    369 / 398 (92.71%)
    Investigations
    Weight Decreased
         subjects affected / exposed
    28 / 398 (7.04%)
         occurrences all number
    33
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    110 / 398 (27.64%)
         occurrences all number
    237
    Excoriation
         subjects affected / exposed
    52 / 398 (13.07%)
         occurrences all number
    85
    Injury
         subjects affected / exposed
    33 / 398 (8.29%)
         occurrences all number
    39
    Joint Sprain
         subjects affected / exposed
    27 / 398 (6.78%)
         occurrences all number
    37
    Laceration
         subjects affected / exposed
    20 / 398 (5.03%)
         occurrences all number
    23
    Skin Laceration
         subjects affected / exposed
    31 / 398 (7.79%)
         occurrences all number
    53
    Thermal Burn
         subjects affected / exposed
    36 / 398 (9.05%)
         occurrences all number
    43
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    63 / 398 (15.83%)
         occurrences all number
    92
    Epilepsy
         subjects affected / exposed
    31 / 398 (7.79%)
         occurrences all number
    37
    Headache
         subjects affected / exposed
    96 / 398 (24.12%)
         occurrences all number
    261
    Somnolence
         subjects affected / exposed
    159 / 398 (39.95%)
         occurrences all number
    226
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    52 / 398 (13.07%)
         occurrences all number
    95
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    29 / 398 (7.29%)
         occurrences all number
    43
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    38 / 398 (9.55%)
         occurrences all number
    67
    Abdominal Pain Upper
         subjects affected / exposed
    20 / 398 (5.03%)
         occurrences all number
    40
    Constipation
         subjects affected / exposed
    45 / 398 (11.31%)
         occurrences all number
    70
    Diarrhoea
         subjects affected / exposed
    69 / 398 (17.34%)
         occurrences all number
    128
    Nausea
         subjects affected / exposed
    44 / 398 (11.06%)
         occurrences all number
    53
    Stomatitis
         subjects affected / exposed
    42 / 398 (10.55%)
         occurrences all number
    75
    Toothache
         subjects affected / exposed
    21 / 398 (5.28%)
         occurrences all number
    32
    Vomiting
         subjects affected / exposed
    40 / 398 (10.05%)
         occurrences all number
    85
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 398 (5.28%)
         occurrences all number
    25
    Pharyngolaryngeal Pain
         subjects affected / exposed
    32 / 398 (8.04%)
         occurrences all number
    60
    Rhinitis Allergic
         subjects affected / exposed
    20 / 398 (5.03%)
         occurrences all number
    26
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    33 / 398 (8.29%)
         occurrences all number
    46
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    47 / 398 (11.81%)
         occurrences all number
    61
    Pruritus
         subjects affected / exposed
    21 / 398 (5.28%)
         occurrences all number
    25
    Rash
         subjects affected / exposed
    26 / 398 (6.53%)
         occurrences all number
    37
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    24 / 398 (6.03%)
         occurrences all number
    26
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    31 / 398 (7.79%)
         occurrences all number
    34
    Back Pain
         subjects affected / exposed
    45 / 398 (11.31%)
         occurrences all number
    70
    Myalgia
         subjects affected / exposed
    21 / 398 (5.28%)
         occurrences all number
    27
    Infections and infestations
    Dental Caries
         subjects affected / exposed
    42 / 398 (10.55%)
         occurrences all number
    49
    Gastroenteritis
         subjects affected / exposed
    27 / 398 (6.78%)
         occurrences all number
    34
    Influenza
         subjects affected / exposed
    32 / 398 (8.04%)
         occurrences all number
    32
    Nasopharyngitis
         subjects affected / exposed
    308 / 398 (77.39%)
         occurrences all number
    1360
    Pharyngitis
         subjects affected / exposed
    25 / 398 (6.28%)
         occurrences all number
    38
    Rhinitis
         subjects affected / exposed
    22 / 398 (5.53%)
         occurrences all number
    26

    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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