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    Clinical Trial Results:
    Efficacy and learning skill after OROS Methylphenidate treatment in adolescents with Attention-Deficit/Hyperactivity Disorder: A 12-week, multi-center, open-label study

    Summary
    EudraCT number
    2015-001084-39
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    23 Apr 2010

    Results information
    Results version number
    v2(current)
    This version publication date
    01 Jul 2016
    First version publication date
    13 Aug 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CONCERTAATT4082
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01060150
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to identify efficacy of 12-week treatment of open-Labeled Osmotic Release Oral System (OROS) methylphenidate by changes of K-ADHD Rating Scale (K-ARS) and Clinical Global Impression – Severity (CGI) scores in Korean Attention Deficit Hyperactivity Disorder (ADHD) adolescents and to evaluate by changes of Learning Skill Test (LST) scores whether there was a change in learning skill in adolescents affected by drug treatment.
    Protection of trial subjects
    Safety evaluations for this study included the monitoring of adverse events, clinical laboratory tests (hematology, serum chemistry and urinalysis), vital sign measurements, physical examination and electrocardiogram (EKG).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Jun 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
    Korea, Republic of: 113
    Worldwide total number of subjects
    113
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    104
    Adults (18-64 years)
    9
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 115 subjects were enrolled in this study, of which 23 subjects were terminated early and a total of 92 subjects completed the study.

    Pre-assignment
    Screening details
    Participants received OROS methylphenidate once daily between 6:30 am and 9:00 am regardless of meals for 12 weeks during the study period. In case of participants who were taking a drug for Attention Deficit Hyperactivity Disorder (ADHD) treatment other than OROS methylphenidate, a washout period was given for one week or more.

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

    Arms
    Arm title
    OROS methylphenidate
    Arm description
    OROS methylphenidate (or methylphenidate hydrochloride) once daily between 6:30 am and 9:00 am regardless of meals for 12 weeks during the study period.
    Arm type
    Experimental

    Investigational medicinal product name
    METHYLPHENIDATE HYDROCHLORIDE
    Investigational medicinal product code
    Other name
    CONCERTA
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CONCERTA capsule 72 mg orally.

    Number of subjects in period 1
    OROS methylphenidate
    Started
    113
    Completed
    92
    Not completed
    21
         Protocol deviation
    6
         Adverse event, non-fatal
    6
         Consent withdrawn by subject
    8
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OROS methylphenidate
    Reporting group description
    OROS methylphenidate (or methylphenidate hydrochloride) once daily between 6:30 am and 9:00 am regardless of meals for 12 weeks during the study period.

    Reporting group values
    OROS methylphenidate Total
    Number of subjects
    113 113
    Age categorical
    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)
    104 104
        Adults (18-64 years)
    9 9
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15.2 ± 1.43 -
    Gender categorical
    Units: Subjects
        Female
    27 27
        Male
    86 86

    End points

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    End points reporting groups
    Reporting group title
    OROS methylphenidate
    Reporting group description
    OROS methylphenidate (or methylphenidate hydrochloride) once daily between 6:30 am and 9:00 am regardless of meals for 12 weeks during the study period.

    Primary: Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score

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    End point title
    Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score [1]
    End point description
    The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition. Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    OROS methylphenidate
    Number of subjects analysed
    113
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    27.58 ± 8.92
        Week 12
    11.78 ± 7.64
    No statistical analyses for this end point

    Primary: Clinical Global Impression - Severity (CGI-S) Score

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    End point title
    Clinical Global Impression - Severity (CGI-S) Score [2]
    End point description
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    OROS methylphenidate
    Number of subjects analysed
    113
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.88 ± 0.79
        Week 12
    2.81 ± 1.12
    No statistical analyses for this end point

    Primary: Clinical Global Impression - Improvement (CGI-I) Score

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    End point title
    Clinical Global Impression - Improvement (CGI-I) Score [3]
    End point description
    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 12
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    OROS methylphenidate
    Number of subjects analysed
    103
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.14 ± 0.75
    No statistical analyses for this end point

    Secondary: Learning Skill Test (LST) Total Score

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    End point title
    Learning Skill Test (LST) Total Score
    End point description
    The LST measures learning ability of student. This scale is composed of 7 sections: self-control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    98 [4]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    40.97 ± 11.07
        Week 12
    49.61 ± 11.57
    Notes
    [4] - Here 'N' signifies number of subjects analysed for this endpoint.
    No statistical analyses for this end point

    Secondary: Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors

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    End point title
    Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors
    End point description
    The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    101
    Units: units on a scale
    arithmetic mean (standard deviation)
        Omission errors: Baseline
    58.88 ± 27.35
        Omission errors: Week 12
    57.4 ± 48.79
        Commission errors: Baseline
    62.39 ± 32.32
        Commission errors: Week 12
    51.7 ± 21.19
    No statistical analyses for this end point

    Secondary: Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability

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    End point title
    Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability
    End point description
    The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor’s score is over 65 point, the participant is resulted in having attention deficit. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    101
    Units: units on a scale
    arithmetic mean (standard deviation)
        Reaction time average: Baseline
    54.32 ± 15.45
        Reaction time average: Week 12
    49.73 ± 26.33
        Response variability: Baseline
    85.77 ± 60.21
        Response variability: Week 12
    59.42 ± 64.77
    No statistical analyses for this end point

    Secondary: Digit Span Test Score

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    End point title
    Digit Span Test Score
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: units on a scale
    arithmetic mean (standard deviation)
        Forward: Baseline
    11.19 ± 2.92
        Forward: Week 12
    11.56 ± 2.9
        Backward: Baseline
    7.09 ± 2.39
        Backward: Week 12
    7.32 ± 2.41
    No statistical analyses for this end point

    Secondary: Finger Window (FW) Test Score

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    End point title
    Finger Window (FW) Test Score
    End point description
    In Finger Window (FW) test, a participant shows memory of a demonstrated visual pattern using an 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: units on a scale
    arithmetic mean (standard deviation)
        Forward FW: Baseline
    18.42 ± 4.6
        Forward FW: Week 12
    19.09 ± 4.49
        Backward FW: Baseline
    15.59 ± 4.97
        Backward FW: Week 12
    17.36 ± 3.84
    No statistical analyses for this end point

    Secondary: Controlled Oral Words Association Test (COWAT) Score

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    End point title
    Controlled Oral Words Association Test (COWAT) Score
    End point description
    This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: words
    arithmetic mean (standard deviation)
        Category/semantic: Baseline
    29.71 ± 5.86
        Category/semantic: Week 12
    30.62 ± 6.16
        Letter/phenomic: Baseline
    28.71 ± 10.82
        Letter/phenomic: Week 12
    33.78 ± 11.18
    No statistical analyses for this end point

    Secondary: Stroop Test Result for Reaction Time

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    End point title
    Stroop Test Result for Reaction Time
    End point description
    This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: seconds
    arithmetic mean (standard deviation)
        Simple execution false reaction: Baseline
    14.78 ± 3.8
        Simple execution false reaction: Week 12
    13.64 ± 3.27
        Middle execution false reaction: Baseline
    15.88 ± 3.56
        Middle execution false reaction: Week 12
    15.04 ± 4.57
        Interfering execution false reaction: Baseline
    22.12 ± 6.18
        Interfering execution time: Week 12
    19.72 ± 5.63
    No statistical analyses for this end point

    Secondary: Stroop Test Result for False Reaction

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    End point title
    Stroop Test Result for False Reaction
    End point description
    This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: errors
    arithmetic mean (standard deviation)
        Simple execution false reaction: Baseline
    0.4 ± 0.77
        Simple execution false reaction: Week 12
    0.16 ± 0.39
        Middle execution false reaction: Baseline
    0.3 ± 0.67
        Middle execution false reaction: Week 12
    0.2 ± 0.47
        Interfering execution false reaction: Baseline
    1.04 ± 1.29
        Interfering execution false reaction: Week 12
    0.84 ± 1
    No statistical analyses for this end point

    Secondary: Stroop Test Score for Ratio Interference

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    End point title
    Stroop Test Score for Ratio Interference
    End point description
    Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation. ITT population included all participants who received the study drug at least once, satisfied the inclusion/exclusion criteria and had efficacy assessment data at the Baseline. Here 'N' signifies number of participants analyzed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    OROS methylphenidate
    Number of subjects analysed
    100
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    0.7 ± 0.19
        Week 12
    0.72 ± 0.19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    OROS methylphenidate
    Reporting group description
    OROS methylphenidate (or methylphenidate hydrochloride) once daily between 6:30 am and 9:00 am regardless of meals for 12 weeks during the study period.

    Serious adverse events
    OROS methylphenidate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 113 (1.77%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    OROS methylphenidate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 113 (86.73%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    12
    Headache
         subjects affected / exposed
    31 / 113 (27.43%)
         occurrences all number
    34
    Somnolence
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    13 / 113 (11.50%)
         occurrences all number
    14
    Irritability
         subjects affected / exposed
    16 / 113 (14.16%)
         occurrences all number
    18
    Psychiatric disorders
    Anger
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    6
    Anxiety
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    9
    Depression
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    9
    Insomnia
         subjects affected / exposed
    37 / 113 (32.74%)
         occurrences all number
    40
    Nervousness
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    7
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    19 / 113 (16.81%)
         occurrences all number
    19
    Diarrhoea
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    32 / 113 (28.32%)
         occurrences all number
    38
    Stomach discomfort
         subjects affected / exposed
    15 / 113 (13.27%)
         occurrences all number
    15
    Vomiting
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    66 / 113 (58.41%)
         occurrences all number
    75
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 113 (16.81%)
         occurrences all number
    22

    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.
    Subject or investigator bias due to placebo effect could not be excluded because this study was conducted in an open-label, single-arm design and learning skill of subjects could not be evaluated by parents and teachers but only depended on subjects.
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