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    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).

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    Summary
    EudraCT Number:2006-002553-80
    Sponsor's Protocol Code Number:ADHD Norrtälje 2006
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-15
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2006-002553-80
    A.3Full title of the trial
    ADHD hos intagna inom Kriminalvården - förekomst/diagnos/behandling/uppföljning
    A.4.1Sponsor's protocol code numberADHD Norrtälje 2006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKarolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.1.1.1Trade name Concerta
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboTablet
    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)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Syftet är att under dubbelblind fas utvärdera effekten av metylfenidat (Concerta) kombinerat med riktad psykosocial behandling på ADHD-symtom hos en grupp vuxna män med ADHD, intagna inom Kriminalvården. De aktuella personerna är samtliga intagna på Norrtäljeanstalten.
    E.2.2Secondary objectives of the trial
    Studera stabilitet i behandlingseffekt av metylfenidat (Concerta) över tid i öppen fas. Studera genomförbarheten av utredning, diagnostik och behandling – såväl farmakologisk som riktad psykosocial, på en grupp vuxna män med ADHD, intagna på Norrtäljeanstalten. Dessutom utvärdera effekten av metylfenidat (Concerta) kombinerat med riktad psykosocial behandling på global funktionsnivå, neuropsykologiska funktionsmått, egenskattade ADHD-symtom och livskvalitet hos denna grupp. Vi kommer även att undersöka i vilken utsträckning personerna får fortsatt läkemedelsbehandling ett och tre år efter studiens slut liksom inventera eventuellt alkohol och narkotikamissbruk vid dessa tidpunkter.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ADHD-screening:
    1. Man, 18-65 år, intagen på Norrtäljeanstalten
    2. Kan läsa och förstå svenska eller engelska.
    3. Signerat informerat samtycke till att delta i ADHD-screening.

    Läkemedelsstudie metylfenidat/placebo och efterföljande öppen fas med metylfenidat:
    1. Positivt utfall vid scIreening för ADHD (WURS: över eller lika med 36 poäng, ASRS: uppfyller 4 kriterier eller mer på screeningdelen).
    2. Kan läsa och förstå svenska.
    3. ADHD-diagnos enligt DSM-IV, vilken konfirmerats med neuropsykiatrisk utredning.

    4. Minst 14 månader kvar till villkorlig frigivning.
    5. Signerat informerat samtycke till att delta i läkemedelsstudien.
    6. Samtycker till att endast ta studieläkemedlet som behandling för sin ADHD under studietiden.
    7. Möjlighet att genomföra de uppgifter som ingår i studien (drogscreening, undersökning, fylla i formulär etc).
    8. Fysiskt frisk vid den kroppsliga undersökningen och har normala blodprover (i de fall blodproverna avviker från det normala, ska detta bedömas sakna klinisk relevans).

    Obs! Inklusionskriterium om mantalsskrivning i Stockholms län är borttaget enligt amendment 2 (tidigare exklusionskriterium nr 4)
    E.4Principal exclusion criteria
    ADHD-screening:
    Inga särskilda exklusionskriterier.

    Läkemedelsstudie metylfenidat/placebo och efterföljande öppen fas med metylfenidat:
    1. Känd non-responder på metylfenidat.
    2. Känd allergi eller överkänslighet för metylfenidat.
    3. Något kliniskt instabilt psykiatriskt tillstånd inkluderat, men inte begränsat till, akut förstämningssyndrom, bipolär sjukdom, akut OCD.
    4. Diagnosticerat missbruk/beroende inom 3 månader innan screeningbesöket för läkemedelsstudien.
    5. Mental retardation.
    6. Tidigare epilepsi, glaukom, obehandlad instabil hypertoni, angina pectoris, hjärtarytmier, eller strukturell hjärtsjukdom (observera hereditet för hjärt-kärlsjukdom, särskilt förekomst av plötslig död, arytmier eller strukturell hjärtsjukdom).
    7. Användande av MAO-hämmare, fluoxetin, venlafaxin, reboxetin, duloxetin.
    8. Användande av alfa-2-receptoragonister, neuroleptika, teofyllin, waran eller antikonvulsiva.
    9. Nedsatt njurfunktion och nedsatt leverfunktion. Personer med kronisk hepatit C utan nedsatt leverfunktion behöver inte exkluderas förutsatt att leverenzymer följs under studiens gång.
    10. Suicidbenägenhet.
    11. Laktosintolerans.
    E.5 End points
    E.5.1Primary end point(s)
    Det primära utfallsmåttet är förändring av ADHD-symtom mätt med skattningsskalan CAARS, en klinikerskattning som kommer att utföras av en oberoende skattare under inledande dubbelblind fas.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.1.7.1Other trial design description
    Först en dubbel-blind 5 -veckorsfas med Concerta/placebo, sedan en öppen fas där alla får Concerta
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state30
    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 Decision2006-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    Protocol
    N.Date of Ethics Committee Opinion2006-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-27
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