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    Clinical Trial Results:
    OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH SPECIAL EDUCATIONAL NEEDS

    Summary
    EudraCT number
    2008-004827-44
    Trial protocol
    GB  
    Global end of trial date
    22 Mar 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Aug 2019
    First version publication date
    24 Aug 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ATOM
    Additional study identifiers
    ISRCTN number
    ISRCTN25691213
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor Emily Simonoff, King's College London, +44 02078485312, emily.simonoff@kcl.ac.uk
    Scientific contact
    Professor Emily Simonoff, King's College London, +44 02078485312, emily.simonoff@kcl.ac.uk
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    What is the efficacy of atomoxetine in reducing the symptoms of ADHD among children with moderate and severe learning disabilities and ADHD?
    Protection of trial subjects
    Following determination of eligibility, informed consent will be obtained from at least one parent with parental responsibility or legal guardian. Children and young people will be given developmentally appropriate information about the disorder, its treatment and the trial. Only exceptionally will children be enrolled where there is disagreement among the parents regarding consent to participate.
    Background therapy
    None
    Evidence for comparator
    not applicable
    Actual start date of recruitment
    11 Nov 2009
    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
    United Kingdom: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    6
    Adolescents (12-17 years)
    5
    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
    Participants were recruited at one site in the UK between 2009 and 2013

    Pre-assignment
    Screening details
    1 Aged 7 - 15 years, 2 Diagnosis of ADHD 3 Full-scale intelligence quotient (IQ) 30 - 69 or age equivalent estimate 4 Did not respond to methylphenidate either at high dose or because dose limited by unacceptable adverse effects 5 Child in stable care situation 6 Child regularly attending school (more than 75% of last school term)

    Pre-assignment period milestones
    Number of subjects started
    11
    Number of subjects completed
    11

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Participants will be randomized immediate start atomoxetine or delayed start by 8 weeks.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Immediate
    Arm description
    Immediate
    Arm type
    Experimental

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Active treatment: Participants randomised to immediate treatment . All participants dosing regime as below:- Week 1 - Strattera 0.5 mg/kg/day (starting dose) during the first week, Week 2 – Strattera 0.8 mg/kg/day (low dose) Week 3 to 16 - 1.2 mg/kg/day (standard dose) or Week 8 to 16 - Subjects showing less than “much improvement” on the CGI—Improvement (CGI-I) scale at the end of week 8, AND experiencing mild or no adverse effects, may have a further dose increase to 1.4 mg/kg/day (high dose).

    Arm title
    Delayed Treatment
    Arm description
    Active treatment: Participants randomised to delayed (8 weeks treatment).
    Arm type
    Active comparator

    Investigational medicinal product name
    Atomoxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Active treatment: Participants randomised to treatment delayed for 8 weeks . All participants dosing regime as below:- Week 1 - Strattera 0.5 mg/kg/day (starting dose) during the first week, Week 2 – Strattera 0.8 mg/kg/day (low dose) Week 3 to 16 - 1.2 mg/kg/day (standard dose) or Week 8 to 16 - Subjects showing less than “much improvement” on the CGI—Improvement (CGI-I) scale at the end of week 8, AND experiencing mild or no adverse effects, may have a further dose increase to 1.4 mg/kg/day (high dose).

    Number of subjects in period 1
    Immediate Delayed Treatment
    Started
    5
    6
    Completed
    5
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    11 11
    Age categorical
    Units: Subjects
        Children (2-12 years)
    6 6
        Adolescents (13-16 years)
    4 4
        Adolescents (17-18 years)
    1 1
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    8 8

    End points

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    End points reporting groups
    Reporting group title
    Immediate
    Reporting group description
    Immediate

    Reporting group title
    Delayed Treatment
    Reporting group description
    Active treatment: Participants randomised to delayed (8 weeks treatment).

    Primary: Primary Efficacy Endpoint

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    End point title
    Primary Efficacy Endpoint [1]
    End point description
    The primary efficacy criteria are reduction in symptoms of hyperactive behaviour (overactivity, poor concentration and impulsivity) as rated by parents and teachers on the ADHD index of the short version of the Conners scale (CRS-S; Conners, 1989). Average baseline ratings taken prior to treatment will be compared to average ratings taken during Week 16
    End point type
    Primary
    End point timeframe
    0-16 weeks
    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: Due to insufficient recruitment, it was not possible to analyse the data obtained. However no safety concerns were raised.
    End point values
    Immediate Delayed Treatment
    Number of subjects analysed
    5
    6
    Units: whole
    5
    6
    No statistical analyses for this end point

    Secondary: Secondary Efficacy Parameters

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    End point title
    Secondary Efficacy Parameters
    End point description
    Secondary efficacy outcome variables: 1.Conners’ hyperactivity scale (parent and teacher) 2.Clinical Global Impressions Scale (improvement) 3.Parent Aberrant Behaviour Scale 4.Teacher Aberrant Behaviour Scale
    End point type
    Secondary
    End point timeframe
    0-16 weeks
    End point values
    Immediate Delayed Treatment
    Number of subjects analysed
    5
    6
    Units: whole
    5
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duraton of Trial
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Immediate Treatment
    Reporting group description
    Participants introduced to atomoxetine straight after the reassessment.

    Reporting group title
    Delayed Treatment
    Reporting group description
    introduced to atomoxetine 8 weeks after reassessment.

    Serious adverse events
    Immediate Treatment Delayed Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Immediate Treatment Delayed Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    6 / 6 (100.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Immune system disorders
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Mumps
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nervous system disorders
    Drowsiness
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Appetite Loss
         subjects affected / exposed
    3 / 5 (60.00%)
    2 / 6 (33.33%)
         occurrences all number
    3
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Upset Stomach
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Being tearful, on and off not related to bad mood
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Irritability
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Sleep problems
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Redness of face
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Leg trauma
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Sore Throat
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2010
    Children and adolescents of both genders aged 7-18 years inclusive at the beginning of trial. Children over 16 should be in full-time education and not expected to leave school within 6 months. Additionally children over 16 will be assessed for their capacity to give consent to participate in the trial using the Mental Capacity Tool (Children over 16 appendix). This tool was designed for use with young adults with intellectual disability, neurodevelopmental or other disorders that might impair their ability to give informed consent. Evidence of potential impairment in capacity includes the diagnosis of learning disability, IQ <70, significant deficity in adaptive functioning, or other signs or symptoms of mental disorder that might compromise capacity to give informed consent. The assessment establishes understanding, retention of information, use of information to make the decision and communication of the decision. These reflect the limbs of the 'capacity test' as defined in the Mental Capacity Act 2005. We expect that the majority of the over 16 children would have difficulties in showing the necessary understanding in order to consent due to their special needs; in these cases a consultee will be appointed following the procedure described in the Children over 16 appendix.
    31 Jan 2011
    1) To change the period off-psychotropic medication from 3 months to 1 month in order for the children to have quicker access to the trial. 2) To clarify that children who ·use to be stimulants should be off them for at least a week.

    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.
    This trial was terminated early due to inability to recruit eligible participants, therefore insufficient data was obtained to perform robust analyses or meet the prirmary endpoints. No safety concerns were raised.
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