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    Clinical Trial Results:
    A 24 weeks prospective open label multicenter study to evaluate the effect on seizure frequency, safety and tolerability of Trileptal® (oxcarbazepine) monotherapy in children with partial seizures

    Summary
    EudraCT number
    		 2015-004465-87
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2016
    First version publication date
    31 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTRI476BRU02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00275912
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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?
    Yes
    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
    28 Sep 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Sep 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    A 24 weeks prospective open label multicenter study to evaluate the effect on seizure frequency, safety and tolerability of Trileptal® (oxcarbazepine) monotherapy in children with partial seizures
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 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
    Russian Federation: 60
    Worldwide total number of subjects
    60
    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)
    2
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    50
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 60 subjects were enrolled in the study.

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

    Arms
    Arm title
    		 Trileptal
    Arm description
    		 Trileptal daily doses received by 58 patients varied from 240 up 1800 mg daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxcarbazepine
    Investigational medicinal product code
    TRI476
    Other name
    Trileptal
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the 1st day, 200 mg of carbamazepine (1/2 tablet) was replaced by 300 mg of Trileptal® (1 tablet). Further each 2-3 days 200 mg of carbamazepine was replaced with 300 mg of Trileptal® until conversion to the monotherapy. Single-time conversion was made in the following way: patient was given carbamazepine dose, then, the next day Trileptal® dose calculated from the dose ratio 1:1.5. The method of conversion was chosen by investigator depending on the patient’s clinical state.

    Number of subjects in period 1
    		Trileptal
    Started
    60
    Completed
    53
    Not completed
    7
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    4
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 60 60
    Age categorical
    Age Breakdown for children is not exactly known. 60 patients were between the ages of 7 months and 17 years. We know for that 8 patients at 2 sites are in the 2-11 age group and that 2 patients at 2 sites are in the infants and toddlers group (28 days to 23 months). The rest of the total distribution is unknown so the other 50 patients are dispersed among the 28 days to 17 years group.
    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)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Children age 6 mos to 17 years
    		 60 60
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.46 ± 5.1 -
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 31 31

    End points

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    End points reporting groups
    Reporting group title
    Trileptal
    Reporting group description
    		 Trileptal daily doses received by 58 patients varied from 240 up 1800 mg daily

    Primary: Rate of response (level of response at least 30% seizure frequency reduction compared to baseline)

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    End point title
    		 Rate of response (level of response at least 30% seizure frequency reduction compared to baseline) [1]
    End point description
    Rate of seizures per week
    End point type
    Primary
    End point timeframe
    week 1-24
    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: Summary results for only one arm...no comparison between groups
    End point values
    		 Trileptal
    Number of subjects analysed
    60
    Units: Seizures
    arithmetic mean (standard deviation)
        Week 1
    10.6 ± 41.86
        Week 2
    8 ± 30.25
        Week 3
    8.24 ± 33.45
        Week 4
    3.1 ± 10.54
        Week 5
    2 ± 5.59
        Week 6
    1.81 ± 6.86
        Week 7
    3.6 ± 18.44
        Week 8
    3.2 ± 18.44
        Week 9
    0.6 ± 1.93
        Week 10
    0.38 ± 1.38
        Week 11
    0.33 ± 1.31
        Week 12
    0.35 ± 1.46
        Week 13
    0.26 ± 1.76
        Week 14
    0.44 ± 2.46
        Week 15
    0.67 ± 4.45
        Week 16
    1.1 ± 7.16
        Week 17
    1.43 ± 9.93
        Week 18
    1.46 ± 9.53
        Week 19
    0.04 ± 0.19
        Week 20
    0.09 ± 0.35
        Week 21
    0.17 ± 0.64
        Week 22
    0.09 ± 0.49
        Week 23
    0.09 ± 0.45
        Week 24
    0.08 ± 0.35
    No statistical analyses for this end point

    Secondary: Percent responders week 7

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    End point title
    		 Percent responders week 7
    End point description
    The patients in whom seizure frequency has not decreased or has increased compared to baseline
    End point type
    Secondary
    End point timeframe
    7 weeks
    End point values
    		 Trileptal
    Number of subjects analysed
    53
    Units: percent
        number (confidence interval 95%)
    90 (79 to 94)
    No statistical analyses for this end point

    Secondary: Percentage of “non-responders”

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    End point title
    		 Percentage of “non-responders”
    End point description
    percentage of “non-responders” (the patients in whom seizure frequency has not decreased or has increased compared to baseline);
    End point type
    Secondary
    End point timeframe
    24 weeeks
    End point values
    		 Trileptal
    Number of subjects analysed
    60
    Units: percent
        number (not applicable)
    2
    No statistical analyses for this end point

    Secondary: • percentage change in seizure frequency from baseline in all patients;

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    End point title
    		 • percentage change in seizure frequency from baseline in all patients;
    End point description
    % reduction in Seizures
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Trileptal
    Number of subjects analysed
    53
    Units: Pecent Change
        number (not applicable)
    -98.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until LSLV.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    oxcarbazepine
    Reporting group description
    		 -

    Serious adverse events
    		 oxcarbazepine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 oxcarbazepine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 60 (38.33%)
    Investigations
    AST rise
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    White cells rise
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    AP rise
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    6
    Eosinophils rise
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Hb reduction
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Platelets reduction
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Serum Na reduction
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Vascular disorders
    Conduction abnormalities (ECG)
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Nervous system disorders
    Craniocerebral trauma
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Ataxia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Slow response
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    Weakness of extremities
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Serial seizures
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Sleepiness
         subjects affected / exposed
    7 / 60 (11.67%)
         occurrences all number
    9
    Tremor of hands
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Astenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Eye disorders
    Redness of conjunctiva
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Swelling of eyelid
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Itching
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Edema
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    7 / 60 (11.67%)
         occurrences all number
    9
    Varicella
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Body weight rise
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Appetite rise
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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