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    Clinical Trial Results:
    A pilot study of Concerta XL in adult offenders with ADHD

    Summary
    EudraCT number
    2012-000517-37
    Trial protocol
    GB  
    Global end of trial date
    23 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Nov 2018
    First version publication date
    08 Nov 2018
    Other versions
    Summary report(s)
    FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    CIAO
    Additional study identifiers
    ISRCTN number
    -
    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 Philip Asherson, King's College London, 44 02078480078, philip.asherson@kcl.ac.uk
    Scientific contact
    Professor Philip Asherson, King's College London, 44 02078480078, philip.asherson@kcl.ac.uk
    Sponsor organisation name
    South London & Maudsley NHS Foundation Trust
    Sponsor organisation address
    Bethlem Royal Hospital, Monks Orchard Road, Beckenham, United Kingdom, BR3 3BX
    Public contact
    Professor Philip Asherson, King's College London, 44 0207848 0078, philip.asherson@kcl.ac.uk
    Scientific contact
    Professor Philip Asherson, King's College London, 44 0207848 0078, philip.asherson@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
    23 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main question is to evaluate the effectiveness of a standard treatment for ADHD on behavioural problems, that are associated with ADHD in young male prisoners. The primary question is whether there is a decrease in aggressive behaviour following treatment of ADHD in a prison setting. Aggression is one of the main problem behaviours within the prison and previous research has shown the strong link between ADHD and aggression within adult prison populations.
    Protection of trial subjects
    Safety remained the responsibility of the prison mental healthcare team. Adverse events of any medical or non-medical intervention identified or recorded by the research team will immediately be informed to 1) the clinical team, and 2) the clinical lead for the project. Participants were aware that should they wish to withdraw from the study they may do so. Participants who become upset or distressed by the questions in the research (this is unlikely as the questions are similar to those asked regularly in the context of their clinical care) will be offered support by the researchers and by the prison mental health team.
    Background therapy
    none
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Feb 2013
    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: 121
    Worldwide total number of subjects
    121
    EEA total number of subjects
    121
    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)
    0
    Adults (18-64 years)
    121
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial took place at HMP YOI Isis, relatively new prison which opened in 2010 &holds sentenced young male adults and category C offenders. There are two house blocks with mixed single and double cells and the operational capacity was measured at 480 in August 2010.

    Pre-assignment
    Screening details
    Screening questionnaire data collected by the prison mental health team will be used to identify those who screen positive for ADHD. Patients who screen positive will be invited to take part in the clinical trial if they meet diagnostic criteria for ADHD following a research diagnostic interview and clinical review by the prison mental health team

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    A 12-week open label pilot study of Concerta XL with dose-escalation to a maximum of 90 mg. Following the initial 12-week trial there will be an open label extension with further titration to an optimal dose for each individual participant, for a period of 6-months.

    Arms
    Arm title
    Full study
    Arm description
    All participants up to 12 week endpoint
    Arm type
    Experimental

    Investigational medicinal product name
    Concerta XL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A 12-week open label pilot study of Concerta XL with dose-escalation to a maximum of 90 mg.

    Number of subjects in period 1
    Full study
    Started
    121
    Completed
    72
    Not completed
    49
         Moved to another prison or released early.
    18
         Physician decision
    4
         Adverse event, non-fatal
    18
         Consent withdrawn by subject
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    Until 12 weeks post dose.

    Reporting group values
    Overall Trial Total
    Number of subjects
    121 121
    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)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
        Aged 18 to 30 years
    121 121
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    121 121

    End points

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    End points reporting groups
    Reporting group title
    Full study
    Reporting group description
    All participants up to 12 week endpoint

    Primary: Primary Outcome

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    End point title
    Primary Outcome [1]
    End point description
    The primary outcome was the total number of adjudications reported by prison officers in the electronic prison records.
    End point type
    Primary
    End point timeframe
    0 to 12 weeks dosing.
    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: Please see attached report for full results and trial outcomes, including full list of adverse events
    End point values
    Full study
    Number of subjects analysed
    72
    Units: whole
    72
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Until 36 weeks post initial dose.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    -

    Serious adverse events
    Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 121 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 121 (64.46%)
    Surgical and medical procedures
    Inguinal hernia
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lump in left testicle
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Lump on genitals
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Lumps on throat getting bigger
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Cyst in mouth
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    cut lip from play fighting
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Social circumstances
    Fighting
         subjects affected / exposed
    5 / 121 (4.13%)
         occurrences all number
    6
    Verbally abusive
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    58 / 121 (47.93%)
         occurrences all number
    58
    Sore Throat
         subjects affected / exposed
    7 / 121 (5.79%)
         occurrences all number
    7
    Sore Lips
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Mouth Ulcer
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Moles and Dry Skin
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Muscle pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    neck pain post exercise
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Nose bleed
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pain in mouth due to small spot
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Scratches on arm
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    6 / 121 (4.96%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Dry and cracked lips
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Feeling unwell
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Gum pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Psychiatric disorders
    Risk of self harm
         subjects affected / exposed
    3 / 121 (2.48%)
         occurrences all number
    5
    Self harmed
         subjects affected / exposed
    5 / 121 (4.13%)
         occurrences all number
    10
    Agitation
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    3
    Appetite loss
         subjects affected / exposed
    4 / 121 (3.31%)
         occurrences all number
    4
    Insomnia
         subjects affected / exposed
    4 / 121 (3.31%)
         occurrences all number
    8
    Low mood
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Hearing voices
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    3
    Twitching hands
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Paranoia
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Segregation
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Twitching
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Diagnosed HSV in sexual health clinic
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pain in testicles
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Genital warts
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Pain in jaw after falling out of bed
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Difficulty breathing & pain in nostril
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Right side of face intermittent swelling
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    2
    Eye disorders
    Unspecified eye problem
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Renal and urinary disorders
    Constipation
         subjects affected / exposed
    3 / 121 (2.48%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    6 / 121 (4.96%)
         occurrences all number
    8
    Eczema
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Fungal infection
         subjects affected / exposed
    3 / 121 (2.48%)
         occurrences all number
    3
    Spots on back
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    visible scars from acne
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pityriasis simplex
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Swollen Upper lip
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Poor appetite
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    3 / 121 (2.48%)
         occurrences all number
    3
    Chest pain
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Leg pain
         subjects affected / exposed
    5 / 121 (4.13%)
         occurrences all number
    5
    Foot pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Knee Pain
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Finger pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pain in Shoulder
         subjects affected / exposed
    3 / 121 (2.48%)
         occurrences all number
    3
    Pain in sternum from fighting
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Pain and swelling from fighting
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Rib pain
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Sore thumb
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Sore knuckle
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Swollen ankle
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Infections and infestations
    Chest Infection
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Cold symptoms
         subjects affected / exposed
    20 / 121 (16.53%)
         occurrences all number
    20
    Cold sore
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1
    Flu symptoms
         subjects affected / exposed
    2 / 121 (1.65%)
         occurrences all number
    2
    Tonsillitis
         subjects affected / exposed
    1 / 121 (0.83%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2013
    The change relates to the secondary outcome that includes an additional brief report from Education and prison staff on participants’ behaviour in class and social time in the prison.
    19 Feb 2014
    The changes relate to the screening process that will enable the team to have a control group to compare the data already collected. There will be changes in the inclusion and exclusion criteria for the study as well to include the control group in the trial.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30180832
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