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    Clinical Trial Results:
    Randomised controlled trial of the short term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention deficit hyperactivity disorder

    Summary
    EudraCT number
    2015-004271-78
    Trial protocol
    GB  
    Global end of trial date
    06 Jun 2019

    Results information
    Results version number
    v2(current)
    This version publication date
    28 May 2021
    First version publication date
    24 Sep 2020
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    errors in the tables
    Summary report(s)
    Clinical Study report

    Trial information

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    Trial identification
    Sponsor protocol code
    CIAOII
    Additional study identifiers
    ISRCTN number
    ISRCTN16827947
    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
    Prof. Philip Asherson, King's College London, +44 2078480078, philip.asherson@kcl.ac.uk
    Scientific contact
    Prof. Philip Asherson, King's College London, +44 2078480078, 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
    27 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is an 8-week randomised placebo controlled trial of OROS-MPH, in young adult prisoners meeting diagnostic criteria for ADHD. OROS-MPH is a long acting stimulant medication used to treat ADHD. The primary objective is to establish the efficacy of OROS-MPH in reducing ADHD symptoms (inattention and hyperactivity-impulsivity) in young male offenders aged 16-25, meeting diagnostic criteria for DSM-5 ADHD.
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. Healthcare staff has the right to withdraw patients from the trial if they consider the trial is having an adverse effect on the participants. However, where the problem is restricted to taking trial medication we will invite participants to remain in the study to complete trial assessments, thereby minimising loss of data. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible. Anyone withdrawn from the clinical trial will be reviewed by the prison healthcare team to ensure their safety. All participants will be informed that they have the right to withdraw from the study at any time. If the trial medication is stopped, the participant will remain in the study and will be asked to complete trial assessments. A clinical assessment will be made on a case by case basis as to the safety of restarting the trial medication after 48 hours from the time of stopping the trial medication. The role of the trial steering committee and data monitoring committee for this trial was to provide independent oversight of ethical and safety aspects of the trial.
    Background therapy
    -
    Evidence for comparator
    It is established that a high proportion of prisoners meet diagnostic criteria for ADHD, with prevalence among prisoners estimated to be between 20 to 30%. It is also established that stimulants such as methylphenidate can reduce the symptoms of ADHD and this is a recommended first line treatment in the UK. However, it is not clear whether prisoners with ADHD will show the same beneficial effects of methylphenidate. Differences may arise because problems with poor attention span, forgetfulness, being overactive and restless or impatient might be better explained by other conditions such as anxiety and depression, personality disorder, post-traumatic stress disorder and drug abuse. This trial follows an open label study investigating the effects of OROS-methylphenidate, an extended release preparation of methylphenidate, showing significant reductions in ADHD symptoms. The trial looks at young male offenders who have undiagnosed or untreated ADHD and investigates the effects of OROS-MPH in this group using a randomised placebo-controlled study design.
    Actual start date of recruitment
    17 Oct 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    10
    Adults (18-64 years)
    190
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was between 17Oct16 and 02Apr19. Participants were recruited from HMP YOI Isis (London) and HM YOI Polmont (Falkirk).

    Pre-assignment
    Screening details
    1183 prisoners consented to be screened. 585 screened negative on the Barkley ADHD self-rating scale and a further 52 excluded. Of the 546 who were then assessed more fully, 153 did not have ADHD , 86 failed to attend, a further 28 were likely to leave the prison during the prison during the course of the trial, and 6 failed eligibility checks.

    Pre-assignment period milestones
    Number of subjects started
    1183 [1]
    Number of subjects completed
    200

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screen fail: 983
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period includes screen fails who were not enrolled into the study.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Over-encapsulated matched placebo

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OROS-MPH
    Arm description
    Concerta XL 18mg (OROS-MPH) prolonged release capsules, taken orally, one to twice daily. Dosing was initiated at 18 mg and increased by 18 mg a week to a maximum dose of 72mg.
    Arm type
    Experimental

    Investigational medicinal product name
    Concerta XL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment will start at an initial dose of 18 mg (1 capsule) for 1 week, and be increased weekly in 18 mg increments to a maximum of 72 mg (4 capsules) (i.e. 18 mg (1 capsule), 36 mg (2 capsule), 54 mg (3 capsules) and 72 mg (4 capsules). Medication will be reduced by 18 mg (1 capsule) if there is a limiting adverse event, in which case there will be no further increase in medication for the duration of the trial. Medication may be provided either once or twice daily up to the maximum daily dose.

    Arm title
    Placebo
    Arm description
    Placebo capsules. The titration protocol is followed in the same way for both active medication (IMP) and placebo.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All trial medication was titrated in the same. Treatment started at an initial dose of 1 capsule of trial medication at the start of week 1. The number of capsules was then increased weekly over the following 4 weeks, in increments of 1 capsule, to a maximum of 4 capsules. This reflected a dose range for the active medication of 18, 36, 54 and 72 mg.

    Number of subjects in period 1
    OROS-MPH Placebo
    Started
    101
    99
    Completed
    90
    94
    Not completed
    11
    5
         Consent withdrawn by subject
    5
    2
         released, deported or moved
    6
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OROS-MPH
    Reporting group description
    Concerta XL 18mg (OROS-MPH) prolonged release capsules, taken orally, one to twice daily. Dosing was initiated at 18 mg and increased by 18 mg a week to a maximum dose of 72mg.

    Reporting group title
    Placebo
    Reporting group description
    Placebo capsules. The titration protocol is followed in the same way for both active medication (IMP) and placebo.

    Reporting group values
    OROS-MPH Placebo Total
    Number of subjects
    101 99 200
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    7 3 10
        Adults (18-64 years)
    94 96 190
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    20.6 ± 1.9 20.8 ± 1.9 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0
        Male
    101 99 200
    Site
    Units: Subjects
        ISIS
    58 57 115
        Polomont
    43 42 85
    Ethnicity
    Units: Subjects
        White
    64 61 125
        Other
    19 10 29
        Black
    18 28 46
    Education
    Units: Subjects
        No qualifications
    42 37 79
        Any qulaifications
    59 62 121
    Age of leaving school
    Units: Subjects
        14 or less
    26 25 51
        15
    32 22 54
        16 or more
    35 43 78
        unknown
    8 9 17
    Employed (including in education)
    Units: Subjects
        Unemployed
    67 66 133
        Employed
    34 33 67
    Offence category
    Units: Subjects
        Serious violence or sexual
    15 14 29
        Assault
    25 26 51
        Drug related
    27 30 57
        Burglary or theft
    27 20 47
        Other
    7 9 16
    Previous ADHD treatment
    Units: Subjects
        Yes
    27 20 47
        No or unknown
    74 79 153
    Age when ADHD meds last taken
    Units: Subjects
        13 or less
    9 3 12
        14 or more
    18 12 30
        Unknown
    74 84 158
    Antisocial Personality Disorder (ASPD)
    baseline co-existing disorders and symptoms from the MINI interview assessment
    Units: Subjects
        Antisocial Personality Disorder (ASPD)
    72 77 149
        No ASPD
    29 22 51
    Mood disorder (major depression, suicidality, manic, hypomanic)
    baseline co-existing disorders and symptoms from the MINI interview assessment
    Units: Subjects
        Mood disorder
    19 19 38
        None
    82 80 162
    Anxiety disorder (panic, agoraphobia, social anxiety, obsessive-compulsive disorder, PTSD)
    baseline co-existing disorders and symptoms from the MINI interview assessment
    Units: Subjects
        Anxiety disorder
    19 19 38
        None
    82 80 162
    Potential problematic alcohol use
    Baseline co-existing disorders and symptoms from the MINI interview assessment. Alcohol use is defined using the AUDIT-C definition of problematic alcohol use, i.e. a score of 5 or more.
    Units: Subjects
        None
    23 28 51
        Potential problematic alcohol use
    78 71 149
    Illicit drug use
    Baseline co-existing disorders and symptoms from the MINI interview assessment. Illicit drug use is defined as any reported use (problematic or not) within the year prior to incarceration of cannabis, cocaine, methamphetamine, inhalants, sedatives, sleeping pills, hallucinogens, street or prescription opioids, spice or other misuse.
    Units: Subjects
        Illicit drug use
    99 95 194
        None
    2 4 6
    WASI-II (IQ)
    Units: Score
        arithmetic mean (standard deviation)
    89.9 ± 13.5 88.9 ± 12.4 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    176.4 ± 7.2 177.2 ± 6.6 -
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    23.7 ± 3.4 23.7 ± 3.7 -
    CAARS-O [range 0-54]
    CAARS-O reported for 100 cases in OROS-MPH arm because there were more than 20% missing items (2 out of 9) in the hyperactivity subscale for one individual
    Units: Score
        arithmetic mean (standard deviation)
    36.4 ± 9.8 37.2 ± 8.7 -
    CAARS-O Inattention [range 0-27]
    Units: Score
        arithmetic mean (standard deviation)
    17.9 ± 5.1 18.5 ± 4.7 -
    CAARS-O Hyperactivity [range 0-27]
    CAARS-O reported for 100 cases in OROS-MPH arm because there were more than 20% missing items (2 out of 9) in the hyperactivity subscale for one individual
    Units: Score
        arithmetic mean (standard deviation)
    18.6 ± 5.7 18.7 ± 5.1 -
    WRAADDS [range 0-30]
    Units: Score
        arithmetic mean (standard deviation)
    17.5 ± 5.7 18.1 ± 5.6 -
    WRAADDS - Temper subscale [range 0-9]
    Units: Score
        arithmetic mean (standard deviation)
    4.7 ± 2.5 5.2 ± 2.3 -
    WRAADDS - Lability subscale [range 0-12]
    Units: Score
        arithmetic mean (standard deviation)
    8.0 ± 2.3 8.1 ± 2.2 -
    WRAADDS - Over-reactivity subscale [range 0-9]
    Units: Score
        arithmetic mean (standard deviation)
    4.8 ± 2.2 4.8 ± 2.3 -
    ARI-S [range 0-14]
    Units: Score
        arithmetic mean (standard deviation)
    9.3 ± 3.5 9.3 ± 3.7 -
    MEWS [range 0-36]
    Units: Score
        arithmetic mean (standard deviation)
    25.7 ± 6.7 26.8 ± 6.2 -
    CGI-severity score [range 1-7]
    Units: Score
        arithmetic mean (standard deviation)
    4.0 ± 1.0 3.9 ± 1.1 -
    CORE-M [range 0-136]
    Units: Score
        arithmetic mean (standard deviation)
    43.5 ± 13.9 44.8 ± 15.3 -
    MVQ [range 0-75]
    MVQ subscale scores were not included in the statistical analysis plan
    Units: Score
        arithmetic mean (standard deviation)
    33.2 ± 9.4 34.6 ± 9.9 -
    Weiss CD [range 0-45]
    Units: Score
        arithmetic mean (standard deviation)
    17.9 ± 7.7 18.7 ± 7.8 -
    Blood pressure systolic
    Units: mmHg
        arithmetic mean (standard deviation)
    123.6 ± 11.2 124.1 ± 11.9 -
    Blood pressure diastolic
    Units: mmHg
        arithmetic mean (standard deviation)
    68.2 ± 9.9 68.1 ± 9.5 -
    Heart rate
    Units: beats per minute
        arithmetic mean (standard deviation)
    70.9 ± 10.7 70.0 ± 11.8 -
    RPAQ_P [range 0-24]
    RPAQ reported for 57 cases in the placebo arm but there were more than 20% missing items for one participant
    Units: Score
        arithmetic mean (standard deviation)
    6.8 ± 5.2 7.6 ± 5.6 -
    RPAQ_R [range 0-22]
    RPAQ reported for 57 cases in the placebo arm but there were more than 20% missing items for one participant
    Units: Score
        arithmetic mean (standard deviation)
    14.1 ± 4.8 14.6 ± 5.0 -
    RPAQ total [range 0-46]
    RPAQ reported for 57 cases in the placebo arm but there were more than 20% missing items for one participant
    Units: Score
        arithmetic mean (standard deviation)
    20.9 ± 9.2 22.2 ± 9.7 -
    CTQ [range 28-140]
    CTQ subscale scores not included in the statistical analysis plan
    Units: Score
        arithmetic mean (standard deviation)
    48.8 ± 18.8 48.9 ± 20.7 -
    ZAN-BPD [range 0-36]
    Units: Score
        arithmetic mean (standard deviation)
    6.9 ± 5.1 6.3 ± 4.2 -
    BSI [range 0-212]
    Units: Score
        arithmetic mean (standard deviation)
    52.5 ± 32.5 52.9 ± 35.9 -
    Depression
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Scores
        median (full range (min-max))
    1 (0 to 7) 1 (0 to 8) -
    Anger
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    4 (0 to 9) 5 (0 to 9) -
    Mania
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 6) 0 (0 to 3) -
    Anxiety
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    1 (0 to 8) 1 (0 to 8) -
    Physical symptoms
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 6) 0 (0 to 5) -
    Suicidal thoughts
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 3) 0 (0 to 3) -
    Psychosis
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 1) 0 (0 to 3) -
    Sleep problems
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    4 (0 to 9) 4 (0 to 10) -
    Memory problems
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    3 (0 to 7) 3 (0 to 7) -
    Repetitive thoughts/behaviours
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 7) 0 (0 to 7) -
    Dissociation
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    0 (0 to 0) 0 (0 to 5) -
    Personality function
    MINI checklist symptom scores [range 0-10 for each item]
    Units: Score
        median (full range (min-max))
    2 (0 to 9) 2 (0 to 8) -

    End points

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    End points reporting groups
    Reporting group title
    OROS-MPH
    Reporting group description
    Concerta XL 18mg (OROS-MPH) prolonged release capsules, taken orally, one to twice daily. Dosing was initiated at 18 mg and increased by 18 mg a week to a maximum dose of 72mg.

    Reporting group title
    Placebo
    Reporting group description
    Placebo capsules. The titration protocol is followed in the same way for both active medication (IMP) and placebo.

    Primary: Reduction in CAARS-O

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    End point title
    Reduction in CAARS-O
    End point description
    The primary outcome measure is the level of ADHD symptoms measured at 8 weeks on the investigator rated Connors Adult ADHD rating scale (CAARS-O). This addressed the question of efficacy of OROS-MPH on ADHD symptoms in young prisoners meeting DSM-5 diagnostic criteria for ADHD.
    End point type
    Primary
    End point timeframe
    Score difference between baseline and 8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    89
    94
    Units: Percentage
    arithmetic mean (standard deviation)
        CAARS-O: total scale
    21.24 ± 33.8
    20.12 ± 29.7
        CAARS-O: inattention subscale
    26.40 ± 36.9
    22.12 ± 35.6
        CAARS-O: hyperactivity/ impulsivity subscale
    11.67 ± 59.3
    16.33 ± 36.4
    Statistical analysis title
    CAARS-O estimated trial arm differences
    Statistical analysis description
    CAARS-O Estimated trial arm differences for the continuous primary and secondary outcomes at week-8 (positive differences indicate an improvement in the OROS-MPH compared to placebo arm)
    Comparison groups
    OROS-MPH v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.71
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.41
         upper limit
    3.56
    Variability estimate
    Standard deviation

    Secondary: The mind excessively wandering scale (MEWS)

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    End point title
    The mind excessively wandering scale (MEWS)
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    90
    94
    Units: Score
        arithmetic mean (standard deviation)
    19.8 ± 10.0
    21.9 ± 9.2
    No statistical analyses for this end point

    Secondary: Cormorbid Symptoms (BSI)

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    End point title
    Cormorbid Symptoms (BSI)
    End point description
    Brief symptom inventory (BSI) - self-rating scale for comorbid symptoms (baseline and outcome rating scale)
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    88
    93
    Units: Scale
        arithmetic mean (standard deviation)
    35.0 ± 25.1
    39.0 ± 34.1
    No statistical analyses for this end point

    Secondary: WRAADDS emotional dysregulation

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    End point title
    WRAADDS emotional dysregulation
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    90
    94
    Units: score
        arithmetic mean (standard deviation)
    13.4 ± 6.1
    14.5 ± 7.0
    No statistical analyses for this end point

    Secondary: ARI-S

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    End point title
    ARI-S
    End point description
    Symptoms of Emotional Dysregulation (ARI)
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    90
    94
    Units: score
        arithmetic mean (standard deviation)
    8.2 ± 4.1
    8.0 ± 4.5
    No statistical analyses for this end point

    Secondary: Core-M

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    End point title
    Core-M
    End point description
    CORE Outcome Measure (CORE-M), a self-rated scale of subjective well-being, problems/symptoms, life functioning and risk/harm, designed to measure psychological distress before and after treatment.
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    89
    94
    Units: Score
        arithmetic mean (standard deviation)
    38.0 ± 12.3
    39.0 ± 13.4
    No statistical analyses for this end point

    Secondary: CGI severity of illness

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    End point title
    CGI severity of illness
    End point description
    clinical global impression
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    OROS-MPH Placebo
    Number of subjects analysed
    89
    94
    Units: Score
        arithmetic mean (standard deviation)
    3.5 ± 1.1
    3.6 ± 1.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to 8 weeks after start of medication
    Adverse event reporting additional description
    Patients are monitored daily. Safety checks will be conducted in line with NICE Guidelines (2009). Other safety checks will include monitoring of AEs during assessments. In addition, participants will be monitored daily by prison staff and any potential adverse events will be reported to the prison healthcare team.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    OROS-MPH
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    OROS-MPH Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 101 (0.00%)
    0 / 99 (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
    OROS-MPH Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 101 (81.19%)
    78 / 99 (78.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm
         subjects affected / exposed
    1 / 101 (0.99%)
    2 / 99 (2.02%)
         occurrences all number
    1
    2
    Immune system disorders
    Hayfever
         subjects affected / exposed
    5 / 101 (4.95%)
    9 / 99 (9.09%)
         occurrences all number
    5
    13
    General disorders and administration site conditions
    General disorders NOS
         subjects affected / exposed
    12 / 101 (11.88%)
    7 / 99 (7.07%)
         occurrences all number
    13
    7
    Psychiatric disorders
    Drug abuse
         subjects affected / exposed
    4 / 101 (3.96%)
    9 / 99 (9.09%)
         occurrences all number
    7
    13
    Depressed mood
         subjects affected / exposed
    12 / 101 (11.88%)
    4 / 99 (4.04%)
         occurrences all number
    13
    6
    Psychiatric symptom
         subjects affected / exposed
    5 / 101 (4.95%)
    5 / 99 (5.05%)
         occurrences all number
    5
    5
    Sleep disorder
         subjects affected / exposed
    11 / 101 (10.89%)
    7 / 99 (7.07%)
         occurrences all number
    11
    7
    Somatic symptom disorder
         subjects affected / exposed
    3 / 101 (2.97%)
    0 / 99 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    bone and joint injures
         subjects affected / exposed
    1 / 101 (0.99%)
    5 / 99 (5.05%)
         occurrences all number
    1
    9
    Soft tissue injury
         subjects affected / exposed
    11 / 101 (10.89%)
    8 / 99 (8.08%)
         occurrences all number
    14
    8
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    4 / 101 (3.96%)
    1 / 99 (1.01%)
         occurrences all number
    4
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    abnormal PLT and Hb
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    dizziness
         subjects affected / exposed
    6 / 101 (5.94%)
    0 / 99 (0.00%)
         occurrences all number
    6
    0
    headache
         subjects affected / exposed
    17 / 101 (16.83%)
    14 / 99 (14.14%)
         occurrences all number
    27
    26
    Seizure
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    eye disorders NOS
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    ocular infection, infestations, irritations and inflammation
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 99 (2.02%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    external ear disorder
         subjects affected / exposed
    3 / 101 (2.97%)
    0 / 99 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    dental and gum disorders
         subjects affected / exposed
    22 / 101 (21.78%)
    15 / 99 (15.15%)
         occurrences all number
    35
    37
    Gastrointestinal motility disorder
         subjects affected / exposed
    11 / 101 (10.89%)
    11 / 99 (11.11%)
         occurrences all number
    11
    12
    gastrointestinal NOS
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 99 (2.02%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    urinary problem NOS
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    epidermal and dermal conditions
         subjects affected / exposed
    16 / 101 (15.84%)
    22 / 99 (22.22%)
         occurrences all number
    20
    26
    Musculoskeletal and connective tissue disorders
    Musculoskeletal disorder
         subjects affected / exposed
    15 / 101 (14.85%)
    13 / 99 (13.13%)
         occurrences all number
    17
    16
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    13 / 101 (12.87%)
    2 / 99 (2.02%)
         occurrences all number
    14
    2
    vitamin related disorders
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences all number
    1
    1
    Infections and infestations
    cold
         subjects affected / exposed
    2 / 101 (1.98%)
    9 / 99 (9.09%)
         occurrences all number
    2
    9
    Balanitis
         subjects affected / exposed
    0 / 101 (0.00%)
    1 / 99 (1.01%)
         occurrences all number
    0
    1
    chest infection
         subjects affected / exposed
    0 / 101 (0.00%)
    2 / 99 (2.02%)
         occurrences all number
    0
    2
    Chlamydia
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences all number
    1
    1
    Trichomoniasis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    urethritis
         subjects affected / exposed
    1 / 101 (0.99%)
    0 / 99 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 101 (0.99%)
    1 / 99 (1.01%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Oct 2018
    Protocol v2.0: Update to secondary endpoints Update to secondary efficacy parameters Eligibility criteria updates Other protocol changes and clarifications

    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/31791384
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