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    Clinical Trial Results:
    A prospective, open-labeled, multicenter study of optimal dosages of Osmotic Release Oral System (OROS)-methylphenidate in treating children and adolescents with Attention-Deficit Hyperactivity Disorder

    Summary
    EudraCT number
    2015-001218-92
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    17 Sep 2007

    Results information
    Results version number
    v2(current)
    This version publication date
    01 Jul 2016
    First version publication date
    31 Jul 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
    CON-KOR-012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Korea Ltd
    Sponsor organisation address
    25th Floor LS Yongsan Tower, 191, Hangangno 2-GA Yongsan-Gu Seoul, Korea, Republic of, 140702
    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
    17 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the optimal dosages of Osmotic Release Oral System (OROS) methylphenidate in Subjects with Attention Deficit Hyperactivity Disorder (ADHD).
    Protection of trial subjects
    Safety were evaluated throughout the study by monitoring of adverse events (AEs), by rating symptom scale, performing laboratory tests, measurement of vital signs, and performing physical examinations.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Aug 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 144
    Worldwide total number of subjects
    144
    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)
    121
    Adolescents (12-17 years)
    23
    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
    This study was conducted in 7 hospitals from August 21, 2006 to September 17, 2007.

    Pre-assignment
    Screening details
    A total of 145 subjects were enrolled in the study and 144 subjects started the study out of these 116 subjects completed the study and 29 subject’s withdrawal the study.

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

    Arms
    Arm title
    Concerta
    Arm description
    Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms.
    Arm type
    Experimental

    Investigational medicinal product name
    Methylphenidate HCl
    Investigational medicinal product code
    Other name
    Concerta
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subject was administered the once daily dose of oral capsule of Methylphenidate hydrochloride in morning.

    Number of subjects in period 1
    Concerta
    Started
    144
    Completed
    116
    Not completed
    28
         Other
    14
         Adverse event, non-fatal
    8
         Lost to follow-up
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Concerta
    Reporting group description
    Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms.

    Reporting group values
    Concerta Total
    Number of subjects
    144 144
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    121 121
        Adolescents (12-17 years)
    23 23
        Adults (18-64 years)
    0 0
        From 65 to 84 years
    0 0
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    8.9 ± 2.44 -
    Title for Gender
    Units: subjects
        Female
    22 22
        Male
    122 122

    End points

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    End points reporting groups
    Reporting group title
    Concerta
    Reporting group description
    Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT population included subjects who were administered with the study drug more than once and provided data for primary efficacy variables.

    Primary: Percentage of Subjects with Remission at Week 12

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    End point title
    Percentage of Subjects with Remission at Week 12 [1]
    End point description
    Remission is defined as the total score of [Korean Version of Adult Attention Deficit Hyperactivity Disorders (ADHD) Rating Scale] (K-ARS) below 18 points and a CGI below 2 (very much improved, much improved). Last observation carried forward (LOCF) was used to impute missing data.
    End point type
    Primary
    End point timeframe
    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
    Concerta
    Number of subjects analysed
    136 [2]
    Units: Units on a scale
        number (not applicable)
    67.86
    Notes
    [2] - ITT Population
    No statistical analyses for this end point

    Secondary: Change in ADHD Diagnostic System (ADS) Score

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    End point title
    Change in ADHD Diagnostic System (ADS) Score
    End point description
    ADS is an objective and standardized Continuous Performance Test (CPT) to evaluate attention. Date for simple selective visual (ssv) and simple selective aural (SSA) were reported. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    Concerta
    Number of subjects analysed
    136 [3]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): SSV: Missing
    69.06 ± 36.86
        Change at Week (Wk) 12: SSV: Missing
    -12.71 ± 43.4
        BL: SSV: False alarm
    72.41 ± 33.59
        Change at Wk 12: SSV: False alarm
    -13.68 ± 25.51
        BL: SSV: Mean reaction time
    53.35 ± 14.72
        Change at Wk 12: SSV: Mean reaction time
    -3.06 ± 11.98
        BL: SSV: SD reaction time
    76.22 ± 34.43
        Change at Wk 12: SSV: SD reaction time
    -10.22 ± 31.45
        Baseline (BL): SSA: Missing
    59.76 ± 21.24
        Change at Wk 12: SSA: Missing
    -9.4 ± 20.24
        BL: SSA: False alarm
    58.23 ± 22.3
        Change at Wk 12: SSA: False alarm
    -8.46 ± 13.91
        BL: SSA: Mean reaction time
    57.03 ± 16.95
        Change at Wk 12: SSA: Mean reaction time
    -1.83 ± 13.56
        BL: SSA: SD reaction time
    62.34 ± 13.99
        Change at Wk 12: SSA: SD reaction time
    -7.76 ± 12.28
    Notes
    [3] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Inattention/Over Activity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 12

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    End point title
    Change From Baseline in Inattention/Over Activity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 12
    End point description
    IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Over activity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    134 [4]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): Total score
    12.66 ± 5.62
        Change at Wk12: Total score
    -6.08 ± 5.88
        BL: Carelessness/ Hyperactivity
    7.12 ± 2.94
        Change at Wk 12: Carelessness/ Hyperactivity
    -3.58 ± 3.15
        BL: Hostile /Rebellious
    5.5 ± 3.47
        Change at Wk 12: Hostile /Rebellious
    -2.43 ± 3.43
    Notes
    [4] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Children's Depression Inventory (CDI) Score at week 12

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    End point title
    Change From Baseline in Children's Depression Inventory (CDI) Score at week 12
    End point description
    The CDI contains 27 items, and measures symptoms of depression in children and adolescents. The CDI ranges in score from 0-54, where higher scores are indicative of a greater number of symptoms. Changes in scores from Baseline to Week 12 were examined. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    109 [5]
    Units: Units on a scale
    median (standard deviation)
        Baseline
    14.11 ± 7.06
        Change at Wk 12
    -3.51 ± 5.86
    Notes
    [5] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in State-Trait Anxiety Inventory for Children (STAI-C) score at Week 12

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    End point title
    Change From Baseline in State-Trait Anxiety Inventory for Children (STAI-C) score at Week 12
    End point description
    State anxiety is the temporary emotional state that can be induced by tension, worry and fear under special circumstances and tends to be changeable in the degree, and Trait anxiety reflects a stable tendency throughout life, and is a measurement used to determine personal differences in response to external threats. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Intent-to-treat (ITT) population
    Number of subjects analysed
    117
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): State anxiety
    34.04 ± 7.67
        Change at Wk 12: State anxiety
    -3.26 ± 8.37
        Baseline (BL): Trait anxiety
    33.25 ± 7.4
        Change at Wk 12: Trait anxiety
    -3.78 ± 5.82
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Yale Global Tic Severity Scale (YGTSS) Score at Week 12

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    End point title
    Change from Baseline in Total Yale Global Tic Severity Scale (YGTSS) Score at Week 12
    End point description
    The Yale Global Tic Severity Scale (YGTSS) is a semi structured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. LOCF was used to impute missing data. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    117 [6]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): Muscle tic
    0.62 ± 2.44
        Change at Wk 12: Muscle tic
    0.36 ± 3.05
        Baseline : Vocal tic
    0.44 ± 2.21
        Change at Wk 12: Vocal tic
    -0.24 ± 1.95
    Notes
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Life Participation Scale-Child (LPS-C) Score at Week 12

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    End point title
    Change from Baseline in Life Participation Scale-Child (LPS-C) Score at Week 12
    End point description
    LPS-C is a short parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affinitive (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social sub scores range from 0-18, and self-control sub scores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    105 [7]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    33.84 ± 9.91
        Change at Wk 12
    7.91 ± 9.63
    Notes
    [7] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12

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    End point title
    Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12
    End point description
    APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    111 [8]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    54.38 ± 11.32
        Change at Wk 12
    9.04 ± 8.11
    Notes
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Parenting Questionnaire Form at Week 12

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    End point title
    Change From Baseline in Parenting Questionnaire Form at Week 12
    End point description
    It consists of 13 questions to evaluate the parental sense of competency (cognitive dimensions) and parental frustration and anxiety (emotional dimensions). It is rated from 1 to 5 points, and it is reversely rated for 5,6th questions. The questionnaire consists of two subcategories of ‘Sense of competency (Questions 1~9)’ and ‘Sense of anxiety (Questions 10~13)’, and the total score of each subcategory is 0 to 45 points and 20 points. A higher score in the ‘Sense of competency” subcategories indicates a high parental sense of competency, and a higher score in the ‘Sense of anxiety’ subcategories indicates high parental frustration and anxiety. LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    117 [9]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (BL): Parental sense of competency
    27.45 ± 5.67
        Change at Wk 12: Parental sense of competency
    0.58 ± 3.6
        BL: Parental frustration stress and anxiety
    13.81 ± 3.39
        Change at Wk 12:frustration stress, anxiety
    -1.25 ± 3.03
    Notes
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 12

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    End point title
    Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 12
    End point description
    The Clinical Global Impression Severity (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 . LOCF was used to impute missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    Concerta
    Number of subjects analysed
    135 [10]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline
    4.9 ± 0.93
        Change at Wk12
    -2.31 ± 1.18
    Notes
    [10] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 7 up to Day 84
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Concerta
    Reporting group description
    Methylphenidate HCl initially either 18 milligram (mg) or 27 mg for weight less than 25 kilogram (kg) and more than 30 kg, respectively, once daily orally. Initial dose was adjusted by the investigator based on the maintenance dose of a previous drug or clinical symptoms.

    Serious adverse events
    Concerta
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 144 (0.69%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 144 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Concerta
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    113 / 144 (78.47%)
    Investigations
    Weight Decreased
         subjects affected / exposed
    4 / 144 (2.78%)
         occurrences all number
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    16 / 144 (11.11%)
         occurrences all number
    0
    Somnolence
         subjects affected / exposed
    8 / 144 (5.56%)
         occurrences all number
    0
    Headache
         subjects affected / exposed
    27 / 144 (18.75%)
         occurrences all number
    0
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    7 / 144 (4.86%)
         occurrences all number
    0
    Fatigue
         subjects affected / exposed
    2 / 144 (1.39%)
         occurrences all number
    0
    Psychiatric disorders
    Anger
         subjects affected / exposed
    9 / 144 (6.25%)
         occurrences all number
    0
    Decreased Interest
         subjects affected / exposed
    5 / 144 (3.47%)
         occurrences all number
    0
    Daydreaming
         subjects affected / exposed
    2 / 144 (1.39%)
         occurrences all number
    0
    Anxiety
         subjects affected / exposed
    11 / 144 (7.64%)
         occurrences all number
    0
    Depression
         subjects affected / exposed
    4 / 144 (2.78%)
         occurrences all number
    0
    Depressed Mood
         subjects affected / exposed
    2 / 144 (1.39%)
         occurrences all number
    0
    Hostility
         subjects affected / exposed
    3 / 144 (2.08%)
         occurrences all number
    0
    Insomnia
         subjects affected / exposed
    42 / 144 (29.17%)
         occurrences all number
    0
    Euphoric Mood
         subjects affected / exposed
    5 / 144 (3.47%)
         occurrences all number
    0
    Nervousness
         subjects affected / exposed
    9 / 144 (6.25%)
         occurrences all number
    0
    Social Avoidant Behaviour
         subjects affected / exposed
    6 / 144 (4.17%)
         occurrences all number
    0
    Nightmare
         subjects affected / exposed
    9 / 144 (6.25%)
         occurrences all number
    0
    Tic
         subjects affected / exposed
    7 / 144 (4.86%)
         occurrences all number
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    18 / 144 (12.50%)
         occurrences all number
    0
    Nausea
         subjects affected / exposed
    13 / 144 (9.03%)
         occurrences all number
    0
    Abdominal Pain Upper
         subjects affected / exposed
    8 / 144 (5.56%)
         occurrences all number
    0
    Vomiting
         subjects affected / exposed
    3 / 144 (2.08%)
         occurrences all number
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    93 / 144 (64.58%)
         occurrences all number
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 144 (4.86%)
         occurrences all number
    0

    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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