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    Clinical Trial Results:
    An open-label study evaluating the Pharmacokinetics and Tolerability of vortioxetine in connection with multiple oral dosing of vortioxetine in child and adolescent patients with a DSM-IV-TRTM diagnosis of Depressive or Anxiety Disorder

    Summary
    EudraCT number
    		 2010-020170-42
    Trial protocol
    		 DE  
    Global end of trial date
    08 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    01 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    12708A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01491035
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark,
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S , +45 36301311, lundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S , +45 36301311, lundbeckClinicalTrials@lundbeck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000455-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
    10 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the pharmacokinetics of vortioxetine, and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TRTM diagnosis of a Depressive or Anxiety Disorder • To assess safety and tolerability of vortioxetine • Provide supportive information for dose regimen in paediatric efficacy and safety studies with vortioxetine
    Protection of trial subjects
    This study was designed and conducted in accordance with the principles of the Declaration of Helsinki. E.g. assent was documented by each patient and consent by his or her legal representative and the corresponding principal investigator or designee, all of whom signed and dated the Informed Consent/Assent Form. A copy of the signed Informed consent/Assent Form was given to the patient and his or her legal representative
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Apr 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    United States: 43
    Worldwide total number of subjects
    48
    EEA total number of subjects
    5
    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)
    24
    Adolescents (12-17 years)
    24
    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
    		 Adolescents (12-17yr) and children (7-11yr) (boys and girls) for whom treatment with antidepressant therapy was warranted, as judged by the investigator, and who had a diagnosis of depressive or anxiety disorder according to DSM-IV-TR (TM) criteria

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adolescents, 5 mg cohort
    Arm description
    		 6 adolescents (12-17 yr). 5 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg tablets for 14 days; orally; once daily

    Arm title
    		 Adolescents, 10 mg cohort
    Arm description
    		 6 adolescents (12-17 yr). 10 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg tablets for 14 days (initial up-titration 5 mg/day for 2 days); orally; once daily

    Arm title
    		 Adolescents, 15 mg cohort
    Arm description
    		 6 adolescents (12-17 yr). 15 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets for 14 days (initial up-titration 5 mg/day for 2 days followed by 10 mg/day for 2 days); orally; once daily

    Arm title
    		 Adolescents, 20 mg cohort
    Arm description
    		 6 adolescents (12-17 yr). 20 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg tablets for 14 days (initial up-titration 5 mg/day for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days); orally; once daily

    Arm title
    		 Children, 5 mg cohort
    Arm description
    		 6 children (7-11 yr). 5 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg tablets for 14 days; orally; once daily

    Arm title
    		 Children, 10 mg cohort
    Arm description
    		 6 children (7-11 yr). 10 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg tablets for 14 days (initial up-titration 5mg/day for two days); orally; once daily

    Arm title
    		 Children, 15 mg cohort
    Arm description
    		 6 children (7-11 yr). 15 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    15 mg tablets for 14 days (initial up-titration 5 mg/day for 2 days followed by 10 mg/day for 2 days); orally; once daily

    Arm title
    		 Children, 20 mg cohort
    Arm description
    		 6 children (7-11 yr). 20 mg tablets for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Lu AA21004, Brintellix®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg tablets for 14 days (initial up-titration 5 mg/day for 2 days followed by 10 mg/day for 2 days and 15 mg/day for 2 days); orally; once daily

    Number of subjects in period 1
    		Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Started
    6
    6
    6
    6
    6
    6
    6
    6
    Completed
    5
    6
    6
    6
    6
    6
    6
    6
    Not completed
    1
    0
    0
    0
    0
    0
    0
    0
         Lost to follow-up
    1
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adolescents, 5 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 5 mg tablets for 14 days.

    Reporting group title
    Adolescents, 10 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 10 mg tablets for 14 days.

    Reporting group title
    Adolescents, 15 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 15 mg tablets for 14 days.

    Reporting group title
    Adolescents, 20 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 20 mg tablets for 14 days.

    Reporting group title
    Children, 5 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 5 mg tablets for 14 days.

    Reporting group title
    Children, 10 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 10 mg tablets for 14 days.

    Reporting group title
    Children, 15 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 15 mg tablets for 14 days.

    Reporting group title
    Children, 20 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 20 mg tablets for 14 days.

    Reporting group values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort Total
    Number of subjects
    		 6 6 6 6 6 6 6 6 48
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.7 ( 1.9 ) 15.3 ( 1.9 ) 15.2 ( 1.2 ) 14.8 ( 1.9 ) 10.3 ( 1.2 ) 9.7 ( 1.2 ) 10.5 ( 0.8 ) 9.8 ( 1.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 5 4 3 3 2 2 25
        Male
    		 3 3 1 2 3 3 4 4 23

    End points

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    End points reporting groups
    Reporting group title
    Adolescents, 5 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 5 mg tablets for 14 days.

    Reporting group title
    Adolescents, 10 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 10 mg tablets for 14 days.

    Reporting group title
    Adolescents, 15 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 15 mg tablets for 14 days.

    Reporting group title
    Adolescents, 20 mg cohort
    Reporting group description
    		 6 adolescents (12-17 yr). 20 mg tablets for 14 days.

    Reporting group title
    Children, 5 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 5 mg tablets for 14 days.

    Reporting group title
    Children, 10 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 10 mg tablets for 14 days.

    Reporting group title
    Children, 15 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 15 mg tablets for 14 days.

    Reporting group title
    Children, 20 mg cohort
    Reporting group description
    		 6 children (7-11 yr). 20 mg tablets for 14 days.

    Primary: Cmax of vortioxetine

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    End point title
    		 Cmax of vortioxetine [1]
    End point description
    Maximum plasma concentration of vortioxetine
    End point type
    Primary
    End point timeframe
    Day 14-20, depending on assigned dose level
    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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: ng/mL
        median (standard deviation)
    4.3 ( 3.7 )
    7.8 ( 2.8 )
    15 ( 6.2 )
    16 ( 8.1 )
    5 ( 3.3 )
    14 ( 8.2 )
    26 ( 21 )
    31 ( 20 )
    No statistical analyses for this end point

    Primary: AUC(0-24h) of vortioxetine

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    End point title
    		 AUC(0-24h) of vortioxetine [2]
    End point description
    Area under the vortioxetine plasma concentration
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: ng*h/mL
        median (standard deviation)
    82 ( 71 )
    144 ( 60 )
    283 ( 115 )
    304 ( 143 )
    89 ( 66 )
    261 ( 137 )
    492 ( 373 )
    562 ( 374 )
    No statistical analyses for this end point

    Primary: t1/2 of vortioxetine

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    End point title
    		 t1/2 of vortioxetine [3]
    End point description
    Half-life of vortioxetine in plasma
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: hour
        median (standard deviation)
    46 ( 33 )
    56 ( 19 )
    50 ( 16 )
    40 ( 10 )
    45 ( 27 )
    52 ( 18 )
    71 ( 52 )
    62 ( 23 )
    No statistical analyses for this end point

    Primary: Cmax of Lu AA34443

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    End point title
    		 Cmax of Lu AA34443 [4]
    End point description
    Maximum plasma concentration of Lu AA34443 (the major inactive metabolite)
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    Notes
    [4] - 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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: ng/mL
        median (standard deviation)
    3.5 ( 2.2 )
    14 ( 7.1 )
    16 ( 5.3 )
    38 ( 12 )
    7.8 ( 3.4 )
    15 ( 5.4 )
    20 ( 13 )
    47 ( 17 )
    No statistical analyses for this end point

    Primary: AUC(0-24h) of Lu AA34443

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    End point title
    		 AUC(0-24h) of Lu AA34443 [5]
    End point description
    Area under the Lu AA34443 (the major inactive metabolite) plasma concentration curve
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    Notes
    [5] - 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 comparison between parameter was performed. Only descriptive statistics are presented here.
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: ng*h/mL
        median (standard deviation)
    56 ( 29 )
    223 ( 98 )
    266 ( 100 )
    544 ( 192 )
    115 ( 47 )
    241 ( 93 )
    429 ( 232 )
    646 ( 251 )
    No statistical analyses for this end point

    Primary: t1/2 of Lu AA34443

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    End point title
    		 t1/2 of Lu AA34443 [6]
    End point description
    Half-life of Lu AA34443 (the major inactive metabolite) in plasma
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    Notes
    [6] - 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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: hour
        median (standard deviation)
    26 ( 9.3 )
    33 ( 13 )
    24 ( 11 )
    24 ( 5.1 )
    20 ( 24 )
    19 ( 9.6 )
    29 ( 6.1 )
    27 ( 8.8 )
    No statistical analyses for this end point

    Primary: Oral clearance (CL/F) of vortioxetine

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    End point title
    		 Oral clearance (CL/F) of vortioxetine [7]
    End point description
    oral clearance expressed as a function of bioavailability
    End point type
    Primary
    End point timeframe
    Day 14, 16, 18 or 20, depending on assigned dose level
    Notes
    [7] - 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 comparison between parameter was performed. Only descriptive statistics are presented here
    End point values
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Number of subjects analysed
    5
    6
    6
    6
    6
    6
    6
    6
    Units: L/h
        median (standard deviation)
    60 ( 55 )
    50 ( 16 )
    50 ( 23 )
    61 ( 20 )
    50 ( 16 )
    42 ( 25 )
    29 ( 33 )
    34 ( 17 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose to follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Adolescents, 5 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Adolescents, 10 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Adolescents, 15 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Adolescents, 20 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Children, 5 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Children, 10 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Children, 15 mg cohort
    Reporting group description
    		 -

    Reporting group title
    Children, 20 mg cohort
    Reporting group description
    		 -

    Serious adverse events
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adolescents, 5 mg cohort Adolescents, 10 mg cohort Adolescents, 15 mg cohort Adolescents, 20 mg cohort Children, 5 mg cohort Children, 10 mg cohort Children, 15 mg cohort Children, 20 mg cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    4 / 6 (66.67%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    5 / 6 (83.33%)
    4 / 6 (66.67%)
    Vascular disorders
    Hot flush
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    1
    0
    Infusion site pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    6
    0
    0
    0
    0
    0
    0
    1
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    Psychiatric disorders
    Frustration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hostility
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Initial insomnia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Restlessness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Investigations
    White blood cells urine positive
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ligament sprain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Sunburn
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Akathisia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    1
    0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    2
    1
    2
    0
    3
    1
    Psychomotor hyperactivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    Sedation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    3 / 6 (50.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    3
    2
    3
    0
    1
    0
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    5
    2
    4
    0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 6 (16.67%)
    3 / 6 (50.00%)
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    6
    5
    2
    0
    1
    0
    Toothache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    3 / 6 (50.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Rash generalised
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Rash macular
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Urticaria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Pollakiuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Pharyngotonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Streptococcal infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    Increased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Pica
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2013
    Visits 6 and 8: phone calls were replaced by visits to the clinic. Visit 9: new visit to the clinic added. PAERS, C-SSRS and vital signs assessments were added to Visits 6, 8, and 9. Confirmatory screening (re-screening for a different cohort) added. Comments/exceptions for Stimulants and other ADHD medications in the list of disallowed recent and concomitant medication was amended.

    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
    For support, Contact us.
    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
    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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