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    Clinical Trial Results:
    Wirkung von Oxcarbazepin (Trileptal) auf den Kortikosteroid-Metabolismus - Pilotstudie

    Summary
    EudraCT number
    		 2007-003913-15
    Trial protocol
    		 AT  
    Global end of trial date
    31 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANTRAG01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Prof. Dr. med. Markus Rauchenzauner, MSc, Kinder-und Jugendmedizin/Neonatologie Klinikum Kaufbeuren, Dr.-Gutermann-Str. 2, 87600 Kaufbeuren, +49 8341 42-2206, Markus.Rauchenzauner@kliniken-oal-kf.de
    Scientific contact
    Prof. Dr. med. Markus Rauchenzauner, MSc, Kinder-und Jugendmedizin/Neonatologie Klinikum Kaufbeuren, Dr.-Gutermann-Str. 2, 87600 Kaufbeuren, +49 8341 42-2206, Markus.Rauchenzauner@kliniken-oal-kf.de
    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
    31 Dec 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Degradation products of endogenous cortisol (e.g. 6OH-Cortisol) in 24-h-urine in patients with temporal lobe epilepsy with oxcarbazepine monotherapy.
    Protection of trial subjects
    All subjects had a physical health check performed.
    Background therapy
    		 There was no background therapy.
    Evidence for comparator
    		 There was no evidence for comparators.
    Actual start date of recruitment
    13 Mar 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
    Austria: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited through epilepsy outpatient clinics.

    Pre-assignment
    Screening details
    		 Exclusion criteria included any other illness apart from epilepsy or being on any other medication apart from Oxcarbazepine.

    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
    		 Oxcarbazepin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxcarbazepin
    Investigational medicinal product code
    Other name
    Trileptal
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were routinely treated with Oxcarbazepin (Dose between 900 and 1500 mg/day or 16 and 21 mg/kg/day)

    Arm title
    		 Control
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Oxcarbazepin Control
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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

    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group values
    		 Oxcarbazepin Control Total
    Number of subjects
    		 6 6 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 6 0 6
        Adults (18-64 years)
    		 0 6 6
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.13 ( 0.44 ) 20.27 ( 4.21 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 6 6 12

    End points

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    End points reporting groups
    Reporting group title
    Oxcarbazepin
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Primary: 6-OHF/F

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    End point title
    		 6-OHF/F
    End point description
    GC-MS measured 24-h urinary excretion of C21 and C19 steroid metabolites. To assess the CYP3A4 elimination pathway, 6-OHF (6β-hydroxycortisol) was determined, as well as the quantified relation to the normal 17-hydroxysteroid elimination pathway using the ratio 6-OHF/F (F, cortisol).
    End point type
    Primary
    End point timeframe
    24-h urine collection
    End point values
    		 Oxcarbazepin Control
    Number of subjects analysed
    6
    6
    Units: µg/day
        arithmetic mean (standard deviation)
    4.67 ( 1.25 )
    2.32 ( 0.50 )
    Statistical analysis title
    		 6-OHF/F
    Comparison groups
    Oxcarbazepin v Control
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Unadjusted result; age-adjusted result (ANCOVA): p<0.05.

    Primary: 6-OHF/(THF+a-THF+THE)

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    End point title
    		 6-OHF/(THF+a-THF+THE)
    End point description
    GC-MS measured 24-h urinary excretion of C21 and C19 steroid metabolites. To assess the CYP3A4 elimination pathway, 6-OHF (6β-hydroxycortisol) was determined, as well as the quantified relation to the normal 17-hydroxysteroid elimination pathway using the ratio 6-OHF/(THF + a-THF + THE). (THF, tetrahydrocortisol; a-THF, allo(5α) THF; THE, tetrahydrocortisone).
    End point type
    Primary
    End point timeframe
    24-h urine collection
    End point values
    		 Oxcarbazepin Control
    Number of subjects analysed
    6
    6
    Units: μg/day
        arithmetic mean (standard deviation)
    0.07 ( 0.03 )
    0.03 ( 0.01 )
    Statistical analysis title
    		 6-OHF/(THF+a-THF+ THE)
    Comparison groups
    Oxcarbazepin v Control
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.02 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - Unadjusted result; age-adjusted result (ANCOVA): p<0.05.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    13.03.2008-31.12.2009
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Oxcarbazepin
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Oxcarbazepin Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oxcarbazepin Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: As only blood and urine were collected in this trial, no AEs and SAEs were observed.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/2051596
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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
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