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    Summary
    EudraCT Number:2012-000517-37
    Sponsor's Protocol Code Number:CIAOProject
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-000517-37
    A.3Full title of the trial
    A pilot study of Concerta XL in adult offenders with ADHD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial of Concerta for the treatment of ADHD in adult offenders
    A.3.2Name or abbreviated title of the trial where available
    CIAO Project
    A.4.1Sponsor's protocol code numberCIAOProject
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportKings College London, Forensic and Neurodevelopmental Science Department (Prof Declan Murphy)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Philip Asherson
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, SGDP, PO80 Institute of Psychiatry, De Crespigny Park,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402078480078
    B.5.5Fax number4402078480866
    B.5.6E-mailphilip.asherson@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportKings College London, Forensic and Neurodevelopmental Science Department (Prof Declan Murphy)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Philip Asherson
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, SGDP, PO80 Institute of Psychiatry, De Crespigny Park
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440207848 0078
    B.5.5Fax number440207848 0866
    B.5.6E-mailphilip.asherson@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Concerta XL
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameConcerta XL
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number18 to 90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention deficit hyperactivity disorder (ADHD)
    E.1.1.1Medical condition in easily understood language
    ADHD
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064104
    E.1.2Term ADHD
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Secondary question relate to the effects of ADHD on the treatment of other behavioural problems within the prison, specifically on engagement with educational activities. This is an important outcome for the rehabilitation process within the prison and previous research shows that treatment of ADHD can lead to improved ability to engage with the educational process.

    Related to the main questions on behavioural outcomes, we will evaluate the effects of treatment on ADHD symptoms and mood dysregulation. Previous clinical trials indicate a good response to methylphenidate on both these sets of symptoms in adults with ADHD.

    Finally we will specifically test the hypothesis that the reduction in ADHD symptoms and emotional dysregulation, following treatment with methylphenidate, leads to any improvements that are seen aggression or engagement with educational activities.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male
    •Aged between 18 and 30 years.
    • English speaking.
    • Able to provide informed consent to participate (understand the protocol and make an informed decision taking into account pros and cons of study participation).
    • Meet clinical diagnostic criteria for ADHD following screening questionnaires for ADHD and diagnostic interview using the DIVA interview. DSM-IV criteria, revised to take into account recommendations from NICE and proposed DSM-V criteria, will use the following criteria:
    - 6 or more symptoms of ADHD in either the inattention or hyperactivity-impulsivity symptom domains as children.
    - 4 or more symptoms of ADHD in either domain as adults.
    - Where it is not possible to gain sufficient clinical information to score childhood symptoms of ADHD, the operational criteria will be adapted to include evidence of some significant symptoms with impairment starting before the age of 12 years, and 6 or more symptoms currently with significant impairment currently.
    -Persistent trait like (non-episodic) course of symptoms.
    - Impairments in two or more clinical or psychosocial domains and two or more settings from symptoms of ADHD.
    - Onset of symptoms before the age of 12 years (following recent national and international guidelines).
    - Symptoms of ADHD not secondary to another medical or mental health condition.
    E.4Principal exclusion criteria
    • Lack capacity to give informed consent
    • Moderate or severe learning disability (defined as IQ < 65)
    • Not English speaking
    • Serious risk of violence to the researcher
    • Pure inattentive subtype, with 2 or less symptoms of hyperactivity-impulsivity
    • Pure hyperactive impulsive subtype, with 3 or less symptoms of inattention
    • Current major depression, psychosis, mania, and episodic hypomania as part of bipolar II disorder
    • Past history of bipolar I or schizophrenia
    • Contraindications to the use of stimulants (glaucoma, hypertension, cardiovascular disease or structural heart problem).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the number of recorded critical incidents (records of disruptive behaviour) in the prison records in the last 3-months prior to the 12-week assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 week assessment
    E.5.2Secondary end point(s)
    Secondary endpoints will be recorded at the 12-week assessment:
    - Ratings of aggressive behaviour by prison and education staffs (Modified Overt Aggression Scale – MOAS)
    - - Engagement with education activities over previous 3 months. (Number of sessions attended, number of reports of disruptive behaviour in educational sessions, behaviour in class and social activities at the prison).
    Symptoms of ADHD (CAARS) and emotional dysregulation (WRAADS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 week assessment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Inmates from Her Majesty's Prison Young Offenders Institution (HMPYOI) Isis
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The participants will have been given a diagnosis of ADHD and the prison clinical care team will continue to provide the medication if the participants wants to and where there is a clear benefit from the treatment. After the participants have left the prison setting this information will be passed on to their GP and arrangements will be made to ensure the continued provision of treatment for ADHD and longer term follow-up and support.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-23
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