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    Clinical Trial Results:
    An open-label, multinational, multicenter, follow-up study to evaluate the long-term safety and efficacy of brivaracetam used at a flexible dose up to a maximum of 200 mg/day in subjects aged 16 years or older suffering from epilepsy.

    Summary
    EudraCT number
    2008-001433-98
    Trial protocol
    BE   CZ   SE   ES   FR   HU   FI   IT   DE  
    Global end of trial date
    20 Mar 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Apr 2018
    First version publication date
    05 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    N01315
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00761774
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biosciences, Inc
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, NC 27617
    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
    10 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Mar 2017
    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 with a maximum of 200 mg/day in subjects suffering from epilepsy.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Not applicable.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    19 Nov 2008
    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: 1
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    United States: 43
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Italy: 7
    Worldwide total number of subjects
    108
    EEA total number of subjects
    52
    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)
    103
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll patients in November 2008 and concluded in March 2017.

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set, 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
    Arm title
    Brivaracetam
    Arm description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
    Arm type
    Experimental

    Investigational medicinal product name
    Brivaracetam
    Investigational medicinal product code
    BRV
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Personalized daily doses of the investigational product (IP) Brivaracetam (BRV) were divided into 2 equal intakes (morning and evening). The suggested individual starting dose of each subject was 100 mg/day. Up- and down-titration could be made by increments of a maximum 50 mg/day on a weekly basis and up to a maximum dose of 200 mg/day.

    Number of subjects in period 1
    Brivaracetam
    Started
    108
    Completed
    29
    Not completed
    79
         Reclassification of seizures
    1
         Subject IP non-compliance
    1
         Patient moved out of study area
    1
         Coordinator leaving site
    1
         Lack of efficacy
    37
         Non-compliance
    4
         End of study
    2
         Consent withdrawn by subject
    9
         IP stopped by hospital physician
    1
         Investigator clinical judgement
    1
         Adverse event, non-fatal
    17
         Lost to follow-up
    2
         Medical decision to read SUSAR reports
    1
         Sponsor decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brivaracetam
    Reporting group description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.

    Reporting group values
    Brivaracetam Total
    Number of subjects
    108 108
    Age categorical
    Units: Subjects
        <=18 years
    0 0
        Between 18 and 65 years
    103 103
        >=65 years
    5 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.8 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    56 56
        Male
    52 52

    End points

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    End points reporting groups
    Reporting group title
    Brivaracetam
    Reporting group description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.

    Subject analysis set title
    Brivaracetam (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.

    Subject analysis set title
    Brivaracetam (ES)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.

    Primary: Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years)

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    End point title
    Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years) [1]
    End point description
    Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
    End point type
    Primary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    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 (SS)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    90.7
    No statistical analyses for this end point

    Primary: Percentage of subjects who withdrew due to Adverse Event (AE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years)

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    End point title
    Percentage of subjects who withdrew due to Adverse Event (AE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years) [2]
    End point description
    Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
    End point type
    Primary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    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 (SS)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    15.7
    No statistical analyses for this end point

    Primary: Percentage of subjects with a Serious Adverse Event (SAE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years)

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    End point title
    Percentage of subjects with a Serious Adverse Event (SAE) during the Evaluation Period from Entry Visit 1 through End of Treatment (up to 9 years) [3]
    End point description
    An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
    End point type
    Primary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    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 (SS)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    24.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects on continuous Brivaracetam monotherapy for at least 3 months of the Evaluation Period (up to 9 years)

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    End point title
    Percentage of subjects on continuous Brivaracetam monotherapy for at least 3 months of the Evaluation Period (up to 9 years)
    End point description
    BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
    End point type
    Secondary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    End point values
    Brivaracetam (ES)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    38.89
    No statistical analyses for this end point

    Secondary: Percentage of subjects on continuous Brivaracetam monotherapy for at least 6 months, of the Evaluation Period (up to 9 years)

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    End point title
    Percentage of subjects on continuous Brivaracetam monotherapy for at least 6 months, of the Evaluation Period (up to 9 years)
    End point description
    BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
    End point type
    Secondary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    End point values
    Brivaracetam (ES)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    32.41
    No statistical analyses for this end point

    Secondary: Percentage of subjects on continuous Brivaracetam monotherapy for at least 12 months of the Evaluation Period (up to 9 years)

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    End point title
    Percentage of subjects on continuous Brivaracetam monotherapy for at least 12 months of the Evaluation Period (up to 9 years)
    End point description
    BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
    End point type
    Secondary
    End point timeframe
    During the Evaluation Period (up to 9 years)
    End point values
    Brivaracetam (ES)
    Number of subjects analysed
    108
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected throughout the study (up to 9 years).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Brivaracetam (SS)
    Reporting group description
    This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.

    Serious adverse events
    Brivaracetam (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 108 (24.07%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Sudden unexplained death in epilepsy
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Factitious disorder
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Somnambulism
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Snake bite
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 108 (2.78%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    5 / 108 (4.63%)
         occurrences causally related to treatment / all
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Monoplegia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postictal state
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 108 (0.93%)
         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
    Brivaracetam (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 108 (75.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    8
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    15 / 108 (13.89%)
         occurrences all number
    19
    Contusion
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    11
    Investigations
    Weight increased
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    17 / 108 (15.74%)
         occurrences all number
    28
    Headache
         subjects affected / exposed
    15 / 108 (13.89%)
         occurrences all number
    20
    Dizziness
         subjects affected / exposed
    14 / 108 (12.96%)
         occurrences all number
    18
    Migraine
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    11
    Paraesthesia
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    6
    Tremor
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    7
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 108 (15.74%)
         occurrences all number
    19
    Chest pain
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    10
    Oedema peripheral
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    15 / 108 (13.89%)
         occurrences all number
    24
    Depression
         subjects affected / exposed
    18 / 108 (16.67%)
         occurrences all number
    21
    Suicidal ideation
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    7
    Insomnia
         subjects affected / exposed
    15 / 108 (13.89%)
         occurrences all number
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    12 / 108 (11.11%)
         occurrences all number
    16
    Abdominal pain
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    12
    Nausea
         subjects affected / exposed
    9 / 108 (8.33%)
         occurrences all number
    11
    Toothache
         subjects affected / exposed
    7 / 108 (6.48%)
         occurrences all number
    10
    Vomiting
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    13 / 108 (12.04%)
         occurrences all number
    16
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    12 / 108 (11.11%)
         occurrences all number
    12
    Arthralgia
         subjects affected / exposed
    10 / 108 (9.26%)
         occurrences all number
    16
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    8 / 108 (7.41%)
         occurrences all number
    13
    Nasopharyngitis
         subjects affected / exposed
    19 / 108 (17.59%)
         occurrences all number
    42
    Viral infection
         subjects affected / exposed
    6 / 108 (5.56%)
         occurrences all number
    8
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 108 (7.41%)
         occurrences all number
    11

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2010
    Updated the protocol with regard to 5 areas:  - Study personnel and contact details  - Duration of the study and duration of participation were amended due to termination of the N01276 and N01306 studies  - Typographical and spelling errors were corrected  - Details concerning the Phase 3 partial onset seizures (POS) and Unverricht-Lundborg Disease (ULD) studies as those studies had completed since the start of this study  - Further instruction was given with regard to visit windows
    02 Aug 2011
    - Increased maximum dose of BRV to 200 mg/day (instead of 150 mg/day) - Reduced the number of assessments for the subjects - Updated procedures for reporting serious adverse events (SAEs) to implement the Food and Drug Administration (FDA) Final Rule requirements - Added Columbia-Suicide Severity Rating Scale (C-SSRS) to address the requirement of the FDA that prospective assessments for suicidality should be included in clinical studies involving all drugs for neurological indications - Updated information on laboratory assessments, statistical analyses, and contact information - Further (minor) changes were made throughout the protocol for consistency between BRV studies
    25 Mar 2015
    - Study personnel and contact details were updated - The ability of the Sponsor to sign electronically was added - Outdated safety information was removed - Protocol language was updated to include the possibility of a named patient or compassionate use program (or similar) as a reason for ending the study duration - Language was revised regarding Investigator deviation from the protocol in the event of a medical emergency to align with the current UCB language

    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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