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    Clinical Trial Results:
    Double-blind study in paediatric epileptic subjects aged from 5 to less than 8 years to compare the subject preference for ESL suspension formulation with alternative flavours

    Summary
    EudraCT number
    		 2012-003137-41
    Trial protocol
    		 SK  
    Global end of trial date
    31 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2016
    First version publication date
    16 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIA-2093-212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02021461
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BIAL - Portela & CA, S.A.
    Sponsor organisation address
    À Av. Siderurgia Nacional, Coronado, Portugal, 4745-457
    Public contact
    André Garrido, BIAL - Portela & Cª, S.A., 00351 229866100, andre.garrido@bial.com
    Scientific contact
    José Francisco Rocha, BIAL - Portela & Cª, S.A., 00351 229866100, jose.rocha@bial.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000696-PIP02-10
    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 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the taste preference in children for 3 different flavours of the ESL oral suspension.
    Protection of trial subjects
    The trial was conducted in accordance with the International Conference on Harmonisation (ICH), Good Clinical Practices (GCP), Good Manufacturing Practice (GMP), the ethical principles of the Declaration of Helsinki and with applicable local regulations. This trial was conducted by qualified persons who respected the rights and welfare of the subjects and after the review and approval of the protocol by an EC. Adverse events were collected during the trial and subject was followed by 4 days after the trial.
    Background therapy
    		 The investigational medicinal product (IMP) in this study is ESL as an oral suspension of 50 mg/mL with 3 different flavours to be tasted but not swallowed. Each of the 3 samples of IMP will consist of 2.5 mL and are to be administered using a spoon. The child is to swill the sample in their mouth for 15-30 seconds before spitting the sample out.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 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
    Romania: 23
    Country: Number of subjects enrolled
    Slovakia: 15
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    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)
    38
    Adolescents (12-17 years)
    0
    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
    		 Planned duration of study (from first subject first visit to last subject last visit): 3 months, with a recruitment period of about 2-3 months. Location of the trial is medical clinic.

    Pre-assignment
    Screening details
    		 Subjects who met all the inclusion criteria and none of the exclusion criteria were included in the clinical trial.

    Pre-assignment period milestones
    Number of subjects started
    		 38
    Number of subjects completed
    		 38

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    ESL will be provided in adequate container closure systems. Each container closure system label will bear at least the following information: name, address and phone number of sponsor, name of Principal Investigator, protocol code, randomisation number, packaging number, expiry date, storage conditions, pharmaceutical dosage form, route of administration, dosing instructions, and the following statements: “For clinical trial use only” and “Keep out of the sight and reach of children”.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ESL Banana taste
    Arm description
    		 Eslicarbazepine acetate (ESL) Banana taste oral suspension with Banana flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Eslicarbazepine acetate (ESL)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the Study Day, all children will be given 3 different flavoured samples of ESL oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. Hence, there should not be any treatment with ESL in this study. Should a subject swallow any of the 3 samples, no further samples are to be given, and appropriate follow-up measures will be taken

    Arm title
    		 ESL Grape taste
    Arm description
    		 Eslicarbazepine acetate (ESL) Grape taste oral suspension with Grape flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Eslicarbazepine acetate (ESL)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the Study Day, all children will be given 3 different flavoured samples of ESL oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. Hence, there should not be any treatment with ESL in this study. Should a subject swallow any of the 3 samples, no further samples are to be given, and appropriate follow-up measures will be taken

    Arm title
    		 ESL Tutti-Frutti taste
    Arm description
    		 Eslicarbazepine acetate (ESL) Tutti-Frutti taste oral suspension with Tutti-Frutti flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eslicarbazepine acetate
    Investigational medicinal product code
    BIA 2-093
    Other name
    Eslicarbazepine acetate (ESL)
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    On the Study Day, all children will be given 3 different flavoured samples of ESL oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. Hence, there should not be any treatment with ESL in this study. Should a subject swallow any of the 3 samples, no further samples are to be given, and appropriate follow-up measures will be taken

    Number of subjects in period 1
    		ESL Banana taste ESL Grape taste ESL Tutti-Frutti taste
    Started
    38
    38
    38
    Completed
    38
    38
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ESL Banana taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Banana taste oral suspension with Banana flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Reporting group title
    ESL Grape taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Grape taste oral suspension with Grape flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Reporting group title
    ESL Tutti-Frutti taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Tutti-Frutti taste oral suspension with Tutti-Frutti flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Reporting group values
    		 ESL Banana taste ESL Grape taste ESL Tutti-Frutti taste Total
    Number of subjects
    		 38 38 38 38
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0 0
        Newborns (0-27days)
    		 0 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0 0
        Children (2-11 years)
    		 38 38 38 38
        Adolescents (12-17 year)
    		 0 0 0 0
        From 18 - 64 years
    		 0 0 0 0
        From 65 – 84 years
    		 0 0 0 0
        Over 85 years
    		 0 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 6.1 ± 0.8 6.1 ± 0.8 6.1 ± 0.8 -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 17 17 17 17
        Male
    		 21 21 21 21

    End points

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    End points reporting groups
    Reporting group title
    ESL Banana taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Banana taste oral suspension with Banana flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Reporting group title
    ESL Grape taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Grape taste oral suspension with Grape flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Reporting group title
    ESL Tutti-Frutti taste
    Reporting group description
    		 Eslicarbazepine acetate (ESL) Tutti-Frutti taste oral suspension with Tutti-Frutti flavour at a concentration of 50 mg/mL and was administered in 2.5 mL doses

    Subject analysis set title
    Eslicarbazepine Acetate
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who received at least 1 sample of IMP and made at least 1 taste assessment

    Primary: Overall taste assessment using Visual Analogue Scale (VAS)

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    End point title
    		 Overall taste assessment using Visual Analogue Scale (VAS) [1]
    End point description
    Subject preference of 3 flavours of the ESL oral suspension assessed using 10 cm VAS.
    End point type
    Primary
    End point timeframe
    1 day
    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: Statistical analysis for end point of overall taste assessment using Visual Analogue Scale (VAS) has not been provided as no confidence intervals were applicable. The overall taste assessment using Visual Analogue Scale (VAS) score was analyzed using a 1-way analysis of variance for repeated measures with the Tukey multiple comparison procedure: Least square mean=21.8, standard error=11.82, p-value=0.1633.
    End point values
    		 ESL Banana taste ESL Grape taste ESL Tutti-Frutti taste
    Number of subjects analysed
    38
    38
    38
    Units: Visual Analogue Scale (VAS)
    arithmetic mean (standard error)
        Visual Analogue Scale (VAS)
    5.8 ± 3.5
    5.8 ± 3.5
    7.1 ± 3.2
    No statistical analyses for this end point

    Primary: Overall taste best/worst assessment

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    End point title
    		 Overall taste best/worst assessment [2]
    End point description
    The subject’s assessment of the overall taste (best, worst)
    End point type
    Primary
    End point timeframe
    1 day
    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: Statistical analysis for end point of overall taste best/worse assessment has not been provided as no confidence intervals were applicable. A Chi-square test was performed on the preference data to test for uniform distribution of scores: p-value=0.1267.
    End point values
    		 ESL Banana taste ESL Grape taste ESL Tutti-Frutti taste
    Number of subjects analysed
    38
    38
    38
    Units: Percentage of Subjects
    number (confidence interval)
        Best: Percentage (CI)
    29 (15 to 43)
    32 (17 to 46)
    40 (24 to 55)
        Worst: Percentage (CI)
    37 (22 to 52)
    45 (29 to 61)
    18 (6 to 31)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    5 days
    Adverse event reporting additional description
    After the first tasting of study treatment until 1-4 days after tasting the IMP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Eslicarbazepine Acetate
    Reporting group description
    		 All treated subjects

    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: None of non-serious adverse events were reported during the trial.
    Serious adverse events
    		 Eslicarbazepine Acetate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 38 (2.63%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Eslicarbazepine Acetate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 38 (0.00%)

    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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