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    The EU Clinical Trials Register currently displays   44241   clinical trials with a EudraCT protocol, of which   7338   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:2017-000368-14
    Sponsor's Protocol Code Number:NCA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-03-30
    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 number2017-000368-14
    A.3Full title of the trial
    A head-to-head randomized clinical trial of methylphenidate and lisdexamphetamine treatment for executive functions and global functioning in adults with ADHD
    En jämförande randomiserad klinisk prövning med metylfenidat och lisdexamfetamine behandling med avseende på exekutiva funktioner och global funktionsnivå hos vuxna personer med ADHD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of methylphenidate and lisdexamphetamine treatment in adults with attention-deficit hyperactivity disorder
    En jämförande studie av metylfenidat och lisdexamfetamine hos vuxna personer med ADHD
    A.3.2Name or abbreviated title of the trial where available
    A clinical trial with two psychostimulants of Central Nervous System in adults with ADHD
    En jämförande studie om två olika centralstimulerande läkemedel hos vuxna med ADHD
    A.4.1Sponsor's protocol code numberNCA
    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 SponsorSahlgrenska Univerisity Hospital Gothenburg
    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 supportSahlgrenska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsykiatrimottagning Centrum
    B.5.2Functional name of contact pointAffektiva kliniken, Sahlgrenska
    B.5.3 Address:
    B.5.3.1Street AddressStora Nygatan 17 1/2
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41108
    B.5.3.4CountrySweden
    B.5.4Telephone number+46700816875
    B.5.6E-mailpeter.sand@vgregion.se
    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 Elvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Limited
    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 nameElvanse
    D.3.4Pharmaceutical form Capsule, hard
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Limited
    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 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
    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
    aktivitets- och uppmärksamhetsstörning
    E.1.1.1Medical condition in easily understood language
    Attention deficit hyperactivity disorder is a mental disorder characterized by problems paying attention, excessive activity, or difficulty controlling behavior
    ADHD är en neuropsykiatrisk funktionsnedsättning som utmärks av nedsatta exekutiva förmågor, exempelvis bristande förmåga att kontrollera uppmärksamheten och/eller hyperaktivitet.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    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
    Primary objectives: to compare Concerta (®), first-line treatment vs adult ADHD, with lisdexamfetamine (®), approved alternative medication with respect to the effect on: clinical symptomathology of ADHD; basal executive functions; global functioning; compliance to the treatment.
    Primära mål: jämförelse av Concerta (®), förstahandsvalet av preparat inom gruppen vuxna med ADHD, med Elvanse (®), godkänt alternativ preparat, med avseende på effekt av: kliniska bilden av ADHD; basala exekutiva funktioner; globala funktioner; behandlingsföljsamhet.
    E.2.2Secondary objectives of the trial
    Secondary objectives: to analyze possible differences (before and during treatment) with respect to the executive functions in adults with ADHD versus healthy / untreated subjects.
    Sekundära mål: analysera eventuella avvikelser (före och under behandlingen) med avseende på de exekutiva funktionerna hos vuxna patienter med ADHD i jämförelse med friska/obehandlade försökspersoner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults 18-45 years of age
    Clinical diagnosis ADHD of any subtype and DSM 5 presentation
    Intellectual ability in the normal range, according to clinical judgment
    Vuxna 18-45 år gamla.
    Klinisk diagnos ADHD av någon subtyp enligt DSM 5.
    Intellektuella förmågor i det normala intervallet, enligt klinisk bedömning.
    E.4Principal exclusion criteria
    Physical or mental limitations that make cognitive evaluations unsuitable.
    Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.
    Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable.
    Substance abuse.
    Subjects who has previously been treated with ADHD medication.
    Fysiska eller psykiska begränsningar som gör kognitiva skattningar
    olämpliga.
    Hjärt-kärlsjukdom, krampanfall eller andra instabila somatiska tillstånd som skulle kontraindicera behandling med centralstimulantia.
    Bipolär sjukdom, uppförandestörning, psykos, svår autism eller annan allvarlig samsjuklighet eller somatiska tillstånd som enligt utredarens bedömning skulle göra deltagandet i studien olämpligt.
    Pågående substansmissbruk.
    Patienter med tidigare behandlingsförsök med centralstimulantia.
    E.5 End points
    E.5.1Primary end point(s)
    6 moths
    6 månader
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 månader
    E.5.2Secondary end point(s)
    6 months
    6 månader
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 månader
    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 Yes
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    singel blind för forskarteam, inte för patienter och förskrivare
    single blind for research team, not for patients and prescribers
    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.8.3 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 120
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state120
    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)
    Continue pharmacological follow-up according to clinical guide-lines
    Fortsatt medicinsk uppföljning enligt riktlinjer
    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 Decision2017-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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