Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-004271-78
    Sponsor's Protocol Code Number:CIAOII
    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:2016-03-30
    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 number2015-004271-78
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    CIAOII
    A.4.1Sponsor's protocol code numberCIAOII
    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 supportNIHR EME
    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 pointProf. Philip Asherson
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, De Crespigny Park
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE58AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442078480078
    B.5.5Fax number+44207848 0892
    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 18 mg prolonged-release tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    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 20.0
    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
    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.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of OROS-MPH in young male offenders aged 16-25, meeting DSM-5 diagnostic criteria for ADHD, on reducing secondary outcomes that are indicators of behavioural and functional impairments used in the management of young prisoners in the UK. These include emotional dysregulation, antisocial behaviour in the prison, violent attitudes (a measure linked to aggression) and reports of behaviour from prison staff.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male, aged between 16 and 25 years (at consent for screening)
    -English speaking (defined as sufficient to complete study assessments)
    -Able to provide informed consent (understand the information sheet and make an informed decision taking into account pros and cons of study participation)
    -Meet clinical diagnostic criteria for DSM-5 ADHD:5 or more symptoms of ADHD in either the inattentive or hyperactive-impulsive symptom domains, 6 or more symptoms of ADHD in either the inattentive or hyperactive-impulsive symptom domains before the age of 12 years, 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 several ADHD symptoms with impairment starting before the age of 12 years, and 5 or more symptoms currently with moderate to severe impairment, 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
    E.4Principal exclusion criteria
    -Lack capacity to give informed consent
    -Moderate or severe learning disability, defined as IQ<60
    -Serious risk of violence to the researcher
    -Current major depression, psychosis, mania or hypomania
    -Past history of bipolar disorder or schizophrenia (exclude those with clear history of episodic mania/hypomania or psychosis unrelated to acute drug intoxication. Do not exclude on the basis of chronic emotional dysregulation i.e. irritability, frustration, anger or emotional-mood instability)
    -Medical contraindications to the use of stimulants (e.g. glaucoma, hypertension, cardiovascular disease or structural heart problem)
    -Is taking a contraindicated medication (e.g Clonidine, Coumarins, Monoamine oxibase inhibitors, Moclobemide, Rasagline) during the 4 week prior to randomnisation.
    -Drug seeking behaviour or craving (defined as drug seeking behaviour that is unusually severe and likely to affect the titration protocol due to unusual and excessive demands for drugs; or where there is a current withdrawal syndrome from an addiction disorder with drug dependency)
    -Participant receiving any ADHD medication between consent for screening and randomisation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the level of ADHD symptoms measured on the investigator rated Connors Adult ADHD rating scale (CAARS-O).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is 8-weeks
    E.5.2Secondary end point(s)
    Secondary outcomes address important exploratory questions about the effects on comorbid symptoms and behavioural impairments that are commonly seen in offenders with ADHD. These include: emotional dysregulation (Wender-Reimherr Adult ADHD Diagnostic Scale, WRAADS) (20); the number of adjudications for antisocial behaviour and rule breaking in the previous 8-weeks; ratings of aggressive behaviour by prison staff and educational staff using the prison officer and education staff versions of the Modified Overt Aggression Scale (MOAS). Attitudes towards violence (Maudsley Violence Questionnaire, MVQ); and 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ADHD and ED symptoms measured at baseline and weeks 1, 2, 3, 4 and 8. Measures of aggression and engagement with educational activities are measured at baseline and then 8 week.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Yes
    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
    End of trial is database lock.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    Participants given a diagnosis of ADHD, prison clinical team will continue to provide medication if the participant wants to and where there is a clear benefit from the treatment. All patients will be reviewed and titrated onto medication at the end of the 8-week trial, if appropriate.After the participants have left the prison setting, information about the diagnosis and treatment will be passed on to GP and the health care team will ensure the continued treatment for ADHD and follow up.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-27
    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.

    European Medicines Agency © 1995-Wed Apr 24 20:20:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA