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    Clinical Trial Results:
    An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older with Epilepsy

    Summary
    EudraCT number
    2012-000827-42
    Trial protocol
    GB   DE   ES   IT  
    Global end of trial date
    09 Aug 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    18 Aug 2017
    First version publication date
    26 Jul 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    For consistency between registries

    Trial information

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    Trial identification
    Sponsor protocol code
    N01372
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01728077
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma SA
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of brivaracetam (BRV) at individualized doses up to a maximum of 200 mg/day as adjunctive treatment in adult subjects with epilepsy.
    Protection of trial subjects
    During the course of the study all subjects were closely monitored. The following safety parameters were assessed at 6 month intervals: • Vital signs • Physical Exam • Neurological Exam • Psychiatric and mental status • Electrocardiogram (ECG) • Seizure assessment • Laboratory assessment • Pregnancy • Review of Adverse Events(AEs)/Medical Procedures • Suicidality Assessment • Quality of Life (QOL) Assessment There are withdrawal criteria specified within the protocol: • Worsening of seizures • Lack/Loss of efficacy • Non-compliance • Prohibited Concomitant Medication • Pregnancy • Significant Liver Function Test (LFT) results • Illness (interfering with continued study participation) • Suicidal ideation • Withdrawal of consent • Lost to follow-up • Sponsor/agency request
    Background therapy
    Background antiepileptic drug (AED) therapy was permitted as described in the protocol.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    17 Oct 2012
    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
    Spain: 2
    Country: Number of subjects enrolled
    United States: 18
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 3
    Worldwide total number of subjects
    26
    EEA total number of subjects
    8
    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)
    0
    Adults (18-64 years)
    26
    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 October 2012 and concluded in August 2016.

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Brivaracetam Focal Epilepsy
    Arm description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
    Arm type
    Experimental

    Investigational medicinal product name
    Brivaracetam
    Investigational medicinal product code
    BRV
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg, 25 mg and 50 mg BRV tablets were used in this study. Subjects started with an individual dose that they had reached at the completion of study N01395 (feeder study). During the study the BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. The BRV 10mg dose (20mg/day) was used only for down-titration.

    Arm title
    Brivaracetam Generalized Epilepsy
    Arm description
    This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.
    Arm type
    Experimental

    Investigational medicinal product name
    Brivaracetam
    Investigational medicinal product code
    BRV
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg, 25 mg and 50 mg BRV tablets were used in this study. Subjects started with an individual dose that they had reached at the completion of study N01395 (feeder study). During the study the BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. The BRV 10mg dose (20mg/day) was used only for down-titration.

    Number of subjects in period 1
    Brivaracetam Focal Epilepsy Brivaracetam Generalized Epilepsy
    Started
    19
    7
    Completed
    11
    2
    Not completed
    8
    5
         Non compliance
    1
    -
         Lack of efficacy
    3
    1
         Adverse event, serious fatal
    -
    1
         Patient moving
    1
    -
         Subject choice
    2
    3
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brivaracetam Focal Epilepsy
    Reporting group description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.

    Reporting group title
    Brivaracetam Generalized Epilepsy
    Reporting group description
    This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.

    Reporting group values
    Brivaracetam Focal Epilepsy Brivaracetam Generalized Epilepsy Total
    Number of subjects
    19 7 26
    Age Categorical
    Units: Subjects
        <=18 years
    0 0 0
        Between 18 and 65 years
    19 7 26
        >=65 years
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    38.6 ± 10.9 30.7 ± 13.2 -
    Gender Categorical
    Units: Subjects
        Female
    7 5 12
        Male
    12 2 14

    End points

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    End points reporting groups
    Reporting group title
    Brivaracetam Focal Epilepsy
    Reporting group description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.

    Reporting group title
    Brivaracetam Generalized Epilepsy
    Reporting group description
    This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day.

    Subject analysis set title
    Brivaracetam Focal Epilepsy (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).

    Subject analysis set title
    Brivaracetam Generalized Epilepsy (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).

    Subject analysis set title
    Brivaracetam Focal Epilepsy (EAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).

    Primary: Incidence of Treatment Emergent Adverse Events (TEAEs) during Evaluation Period

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    End point title
    Incidence of Treatment Emergent Adverse Events (TEAEs) during Evaluation Period [1]
    End point description
    TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
    End point type
    Primary
    End point timeframe
    From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
    Number of subjects analysed
    19
    7
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    78.9
    71.4
    No statistical analyses for this end point

    Primary: Percentage of subjects withdrawn due to an Adverse Event (AE) during the Evaluation Period

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    End point title
    Percentage of subjects withdrawn due to an Adverse Event (AE) during the Evaluation Period [2]
    End point description
    An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE.
    End point type
    Primary
    End point timeframe
    From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
    Number of subjects analysed
    19
    7
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    0
    14.3
    No statistical analyses for this end point

    Primary: Occurrence of a Serious Adverse Event (SAE) during the Evaluation Period

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    End point title
    Occurrence of a Serious Adverse Event (SAE) during the Evaluation Period [3]
    End point description
    SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study.
    End point type
    Primary
    End point timeframe
    From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
    Number of subjects analysed
    19
    7
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    26.3
    28.6
    No statistical analyses for this end point

    Secondary: Frequency of Partial-Onset Seizure (POS) Type I per 28 days during the Evaluation Period for subjects with focal-onset Epilepsy

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    End point title
    Frequency of Partial-Onset Seizure (POS) Type I per 28 days during the Evaluation Period for subjects with focal-onset Epilepsy
    End point description
    The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days.
    End point type
    Secondary
    End point timeframe
    From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
    End point values
    Brivaracetam Focal Epilepsy (EAS)
    Number of subjects analysed
    17
    Units: Seizures per 28 days
    median (full range (min-max))
        median (min, max)
    0.4 (0 to 124)
    No statistical analyses for this end point

    Secondary: Percentage of change in Partial-Onset-Seizure (POS) Type I frequency per 28 days from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected

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    End point title
    Percentage of change in Partial-Onset-Seizure (POS) Type I frequency per 28 days from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected
    End point description
    The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
    End point values
    Brivaracetam Focal Epilepsy (EAS)
    Number of subjects analysed
    17
    Units: percentage of change
    median (full range (min-max))
        median (min, max)
    -56.3 (-97 to 717)
    No statistical analyses for this end point

    Secondary: 50 % responder rate in Partial-Onset-Seizure (POS) Type I frequency from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected

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    End point title
    50 % responder rate in Partial-Onset-Seizure (POS) Type I frequency from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected
    End point description
    The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency.
    End point type
    Secondary
    End point timeframe
    From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
    End point values
    Brivaracetam Focal Epilepsy (EAS)
    Number of subjects analysed
    17
    Units: percentage of subjects
    number (not applicable)
        percentage of subjects
    54.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events collection started at Day 0 and continued up to 30 days after last intake of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Brivaracetam Generalized Epilepsy (SS)
    Reporting group description
    This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).

    Reporting group title
    Brivaracetam Focal Epilepsy (SS)
    Reporting group description
    This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject’s seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).

    Serious adverse events
    Brivaracetam Generalized Epilepsy (SS) Brivaracetam Focal Epilepsy (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    5 / 19 (26.32%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Conversion disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Brivaracetam Generalized Epilepsy (SS) Brivaracetam Focal Epilepsy (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 7 (71.43%)
    13 / 19 (68.42%)
    Investigations
    Crystal urine present
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    White blood cell count increased
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Protein urine present
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Urinary casts
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    7 / 19 (36.84%)
         occurrences all number
    1
    68
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    29
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    3
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    1
    3
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 19 (5.26%)
         occurrences all number
    1
    20
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 19 (15.79%)
         occurrences all number
    2
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 19 (10.53%)
         occurrences all number
    3
    3
    Bronchitis
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 19 (10.53%)
         occurrences all number
    1
    2
    Upper respiratory tract
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 19 (5.26%)
         occurrences all number
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    4
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2013
    This Amendment was implemented after the date of first subject first visit (FSFV, 25 subjects had enrolled in the study as of the date of this amendment). The rationale for this amendment was to clarify that data for the following variables were to only be collected and analyzed for subjects with epilepsy that entered N01372 from a study in which a Baseline value for that variable was previously collected: - Percent reduction in Type I partial-onset seizures (POS) frequency per 28 days from Baseline of the previous study into the Evaluation Period - Responder rate in POS (Type I) frequency over the Evaluation Period - Percent reduction in generalized (Type II) seizure days per 28 days from Baseline of the previous study to the Evaluation Period - Responder rate for generalized (Type II) seizure days over the Evaluation Period - Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score - Hospital stays and healthcare provider consultations. Additionally, Inclusion Criterion 7 was added, which required subjects to be able to take the oral film-coated tablets of Brivaracetam (BRV). References to specific BRV studies were removed and a statement was added to clarify that the study was to enroll subjects who had completed the Treatment Period of an applicable BRV study. Administrative changes included an update to the Clinical Trial Biostatistician and Study Physician.

    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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