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    Clinical Trial Results:
    A randomized, rater-blinded cross-over multicenter study comparing the clinical efficacy of Ritalin® LA (methylphenidate) treatment (20 or 40 mg orally o.d.) in children with ADHD under different breakfast conditions over two weeks Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    		 2006-006441-14
    Trial protocol
    		 DE  
    Global end of trial date
    18 Dec 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRIT124DDE04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00428792
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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
    18 Dec 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the clinical efficacy of a modified-release oral dosage of methylphenidate under nearly fasted conditions and standard breakfast conditions in children with Attention deficit hyperactivity disorder (ADHD) after treatment for one week assessed by weekly teacher-based ratings Fremdbeobachtungsbogen Aufmerksamkeitsdefizit-Hyperaktivitätssyndrom (FBB-ADHS) scale.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2007
    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
    Germany: 150
    Worldwide total number of subjects
    150
    EEA total number of subjects
    150
    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)
    131
    Adolescents (12-17 years)
    19
    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
    		 The study was conducted at 13 centres in Germany.

    Pre-assignment
    Screening details
    		 A total of 159 subjects were screened, of which 150 were randomized to this cross-over study.Remaining 9 subjects were screen failures.

    Period 1
    Period 1 title
    First Intervention Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    The study was considered rater-blinded i.e. teachers and treating physicians. Primary evaluations were carried out by teachers who were blinded to the treatment arms. Individual sets of code-breaker scratch cards containing the actual treatment assignment were prepared for each container of medication and distributed to each investigator. The scratch cards were not to be opened unless an actual emergency occurred, and were returned to sponsor at end of study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Methylphenidate+VLB then Methylphenidate+SB
    Arm description
    		 All subjects who were randomized to treatment sequence 1, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with very light breakfast (VLB) of 150 -180 calories once daily for a week in treatment period 1. In treatment period 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with standard breakfast (SB) of 450 -600 calories once daily for a week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylphenidate
    Investigational medicinal product code
    RIT124
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methylphenidate (20 mg or 40 mg) was administered with VLB or SB once daily for a week.

    Arm title
    		 Methylphenidate+SB then Methylphenidate+VLB
    Arm description
    		 All subjects who were randomized to treatment sequence 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week in treatment period 1. In treatment period 2, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Methylphenidate
    Investigational medicinal product code
    RIT124
    Other name
    Ritalin LA
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methylphenidate (20 mg or 40 mg) was administered with SB or VLB once daily for a week.

    Number of subjects in period 1
    		Methylphenidate+VLB then Methylphenidate+SB Methylphenidate+SB then Methylphenidate+VLB
    Started
    80
    70
    Completed
    79
    68
    Not completed
    1
    2
         Lack of efficacy
    1
    2
    Period 2
    Period 2 title
    Second Intervention Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Assessor, Subject
    Blinding implementation details
    The study was rater-blinded i.e. teachers and treating physicians. Primary evaluations were carried out by teachers who were blinded to the treatment arms. Individual sets of code-breaker scratch cards containing the actual treatment assignment were prepared for each container of medication and distributed to each investigator. The scratch cards were not to be opened unless an actual emergency occurred, and were returned to sponsor at end of study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Methylphenidate+VLB then Methylphenidate+SB
    Arm description
    		 All subjects who were randomized to treatment sequence 1, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week in treatment period 1. In treatment period 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylphenidate
    Investigational medicinal product code
    RIT124
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methylphenidate (20 mg or 40 mg) was administered with VLB or SB once daily for a week.

    Arm title
    		 Methylphenidate+SB then Methylphenidate+VLB
    Arm description
    		 All subjects who were randomized to treatment sequence 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week in treatment period 1. In treatment period 2, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Methylphenidate
    Investigational medicinal product code
    RIT124
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methylphenidate (20 mg or 40 mg) was administered with SB or VLB once daily for a week.

    Number of subjects in period 2
    		Methylphenidate+VLB then Methylphenidate+SB Methylphenidate+SB then Methylphenidate+VLB
    Started
    79
    68
    Completed
    79
    66
    Not completed
    0
    2
         Lost to follow-up
    -
    1
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Methylphenidate+VLB then Methylphenidate+SB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 1, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with very light breakfast (VLB) of 150 -180 calories once daily for a week in treatment period 1. In treatment period 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with standard breakfast (SB) of 450 -600 calories once daily for a week.

    Reporting group title
    Methylphenidate+SB then Methylphenidate+VLB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week in treatment period 1. In treatment period 2, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week.

    Reporting group values
    		 Methylphenidate+VLB then Methylphenidate+SB Methylphenidate+SB then Methylphenidate+VLB Total
    Number of subjects
    		 80 70 150
    Age categorical
    Units: Subjects
        Children (6-12 years)
    		 80 70 150
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.6 ( 1.6 ) 9.7 ( 1.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 13 38
        Male
    		 55 57 112

    End points

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    End points reporting groups
    Reporting group title
    Methylphenidate+VLB then Methylphenidate+SB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 1, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with very light breakfast (VLB) of 150 -180 calories once daily for a week in treatment period 1. In treatment period 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with standard breakfast (SB) of 450 -600 calories once daily for a week.

    Reporting group title
    Methylphenidate+SB then Methylphenidate+VLB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week in treatment period 1. In treatment period 2, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week.
    Reporting group title
    Methylphenidate+VLB then Methylphenidate+SB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 1, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week in treatment period 1. In treatment period 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week.

    Reporting group title
    Methylphenidate+SB then Methylphenidate+VLB
    Reporting group description
    		 All subjects who were randomized to treatment sequence 2, subjects received methylphenidate (20 mg or 40 mg depending on their previous treatment) with SB of 450 -600 calories once daily for a week in treatment period 1. In treatment period 2, received methylphenidate (20 mg or 40 mg depending on their previous treatment) along with VLB of 150 -180 calories once daily for a week.

    Subject analysis set title
    Methylphenidate + SB
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who received methylphenidate along with SB of 450-600 calories once daily for two weeks in this cross-over study.

    Subject analysis set title
    Methylphenidate + VLB
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who received methylphenidate (20 mg or 40 mg) with VLB of 150-180 calories once daily for two weeks in this cross-over study.

    Primary: Fremdbeurteilungsbogen for attention deficit/hyperactivity disorder (FBB-ADHS) rating total score in Intent to Treat population

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    End point title
    		 Fremdbeurteilungsbogen for attention deficit/hyperactivity disorder (FBB-ADHS) rating total score in Intent to Treat population
    End point description
    The FBB-ADHS was a 20-item rating scale, where each item described a typical ADHD symptoms. The 20 items were divided into 3 subscales: attention deficit (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item was rated on a scale of 0 up to 3 (0: not at all, 3: very much). A total score was calculated by averaging out the scores of 20 items and ranged from 0 to 3. A higher score signifies more severe symptoms of ADHD. The analysis was performed in Intention to treat population, defined as all randomized subjects with at least one post-baseline measurement of the primary endpoint in both study periods.
    End point type
    Primary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    144 [1]
    144 [2]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.97 ( 0.63 )
    1.01 ( 0.63 )
    Notes
    [1] - Intent to treat population
    [2] - Intent to treat population
    Statistical analysis title
    		 Test for non-inferiority
    Comparison groups
    Methylphenidate + VLB v Methylphenidate + SB
    Number of subjects included in analysis
    288
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.02
    Notes
    [3] - [4] - 1-sided p-value of the test for non-inferiority (Δ=0.3 points)

    Secondary: FBB-ADHS teacher-rated attention deficit subscale score

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    End point title
    		 FBB-ADHS teacher-rated attention deficit subscale score
    End point description
    The FBB-ADHS was a 20-item rating scale, where each item described a typical ADHD symptom. Teacher rated 9 items of the attention deficit subscale of FBB-ADHS on a scale of 0 up to3 (0: not at all to 3: very much). A total score was calculated by averaging out the scores of 9 items and ranged from 0 to 3. A higher score signifies more severe symptoms of ADHD. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    144
    144
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.19 ( 0.68 )
    1.23 ( 0.69 )
    No statistical analyses for this end point

    Secondary: FBB-ADHS teacher-rated hyperactivity subscale score

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    End point title
    		 FBB-ADHS teacher-rated hyperactivity subscale score
    End point description
    The FBB-ADHS was a 20-item rating scale, where each item described a typical ADHD symptom. Teacher rated 7 items of the hyperactivity subscale of FBB-ADHS on a scale of 0 up to 3 (0: not at all to 3: very much). A total score was calculated by averaging out the scores of 7 items and ranged from 0 to 3. A higher score signifies more severe symptoms of ADHD. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    144
    144
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.72 ( 0.7 )
    0.75 ( 0.69 )
    No statistical analyses for this end point

    Secondary: FBB-ADHS teacher-rated impulsiveness subscale score

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    End point title
    		 FBB-ADHS teacher-rated impulsiveness subscale score
    End point description
    The FBB-ADHS was a 20-item rating scale, where each item described a typical ADHD symptom. Teacher rated 4 items of the impulsiveness subscale of FBB-ADHS on a scale of 0 up to 3 (0: not at all to 3: very much). A total score was calculated by averaging out the scores of 4 items and ranged from 0 to 3. A higher score signifies more severe symptoms of ADHD. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    144
    144
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.93 ( 0.92 )
    0.99 ( 0.9 )
    No statistical analyses for this end point

    Secondary: FBB-ADHS parent-rated total score

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    End point title
    		 FBB-ADHS parent-rated total score
    End point description
    The FBB-ADHS was a 20-item rating scale, where each item described a typical ADHD symptom. The 20 items were divided into 3 subscales: attention deficit (9 items), hyperactivity (7 items), and impulsiveness (4 items). Each item was rated on a scale of 0 up to 3 (0: not at all, 3: very much). A total score was calculated by averaging out the scores of 20 items and ranged from 0 to 3. A higher score signifies more severe symptoms of ADHD. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    143
    144
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.15 ( 0.6 )
    1.11 ( 0.55 )
    No statistical analyses for this end point

    Secondary: Math test objective rating score

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    End point title
    		 Math test objective rating score
    End point description
    A standardized 10-Minute Math Test, consisting of math problems presented in ascending order of difficulty (requiring addition, subtraction, multiplication and division calculations respectively) was provided to the subjects. Test difficulty was altered for subjects at different skill levels and ages. The number of problems attempted and the number of problems correctly answered were generated as objective measures related to academic productivity. The test was carried out under supervision of a trained teacher. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    142
    142
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Problems attempted
    116.3 ( 56.14 )
    118.1 ( 57.74 )
        Problems solved
    106.7 ( 58.34 )
    108.6 ( 60.67 )
    No statistical analyses for this end point

    Secondary: Clinical global impression severity (CGI-S) physician-rated score

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    End point title
    		 Clinical global impression severity (CGI-S) physician-rated score
    End point description
    The CGI scale was utilized to assess the global severity of illness (CGI-S). The physician provided rating based on one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Ratings were on a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill subjects. The rating was based upon the average observed and reported symptoms, behavior, and function in the past 7 days. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    142
    143
    Units: Units on a scale
        arithmetic mean (standard deviation)
    2.75 ( 1.45 )
    2.74 ( 1.48 )
    No statistical analyses for this end point

    Secondary: Clinical global impression improvement (CGI-I) physician-rated score

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    End point title
    		 Clinical global impression improvement (CGI-I) physician-rated score
    End point description
    The CGI-I scale was utilized to assess improvement (change in state) of illness. The rating was based on the investigator answering one question: “Compared to the patient’s condition prior to medication, this patient’s condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.” The investigator compared the patient’s overall clinical condition to week just prior to the initiation of medication. The analysis was performed in ITT population.
    End point type
    Secondary
    End point timeframe
    Day 8, Day 15
    End point values
    		 Methylphenidate + VLB Methylphenidate + SB
    Number of subjects analysed
    142
    142
    Units: Units on a scale
        arithmetic mean (standard deviation)
    3.49 ( 1.08 )
    3.56 ( 1.18 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Total
    Reporting group description
    		 All subjects who received methylphenidate along with breakfast once daily for two weeks in this cross-over study.

    Reporting group title
    Methylphenidate + SB
    Reporting group description
    		 All subjects who received methylphenidate along with SB of 450-600 calories once daily for two weeks in this cross-over study.

    Reporting group title
    Methylphenidate + VLB
    Reporting group description
    		 All subjects who received methylphenidate (20 mg or 40 mg) with VLB of 150-180 calories once daily for two weeks in this cross-over study.

    Serious adverse events
    		 Total Methylphenidate + SB Methylphenidate + VLB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 150 (0.00%)
    0 / 149 (0.00%)
    0 / 148 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total Methylphenidate + SB Methylphenidate + VLB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 150 (12.67%)
    9 / 149 (6.04%)
    11 / 148 (7.43%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    8 / 150 (5.33%)
    3 / 149 (2.01%)
    6 / 148 (4.05%)
         occurrences all number
    9
    3
    6
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    9 / 150 (6.00%)
    4 / 149 (2.68%)
    5 / 148 (3.38%)
         occurrences all number
    9
    4
    5
    NAUSEA
         subjects affected / exposed
    8 / 150 (5.33%)
    4 / 149 (2.68%)
    4 / 148 (2.70%)
         occurrences all number
    8
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2007
    1. The study completion visits for the different extension phases were harmonized. 2. The definition of the per-protocol population was modified by adding the breakfast compliance for inclusion in the per-protocol analysis.

    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.
    Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.
    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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