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    Summary
    EudraCT Number:2014-001488-11
    Sponsor's Protocol Code Number:2014-10-16
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 number2014-001488-11
    A.3Full title of the trial
    Effects of expectations, medication and placebo on objective and self-rated performance during the Quantified Behavior Test in terms of the ADHD core signs hyperactivity, inattention and impulsivity in patients with untreated ADHD and Substance Use Disorder
    Effekten av förväntning, aktivt läkemedel och placebo på objektiv och självskattad prestation vid QbTest avseende ADHD-kärnsymtomen hyperaktivitet, ouppmärksamhet och impulsivitet hos patienter med obehandlad ADHD och substanssyndrom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD and Substance Use Disorder
    Effekten av förväntning, läkemedel och placebo på objektiv och självskattad prestation vid QbTest hos patienter med obehandlad ADHD och substanssyndrom
    A.4.1Sponsor's protocol code number2014-10-16
    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 SponsorLandstinget Västmanland
    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 supportLandstinget Västmanland
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLandstinget Västmanland
    B.5.2Functional name of contact pointBlanca Domingo
    B.5.3 Address:
    B.5.3.1Street AddressBeroendecentrum Västmanland, Psykiatricentrum ingång 29
    B.5.3.2Town/ cityVästerås
    B.5.3.3Post codeSE-72189
    B.5.3.4CountrySweden
    B.5.4Telephone number004621175931
    B.5.5Fax number004621174100
    B.5.6E-mailblanca.domingo.arnaiz@ltv.se
    D. IMP Identification
    D.IMP: 1
    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 Medikinet
    D.2.1.1.2Name of the Marketing Authorisation holderEvolan Pharma 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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
    D.3.9.1CAS number 113-45-1
    D.3.9.4EV Substance CodeSUB08870MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Effects of expectations, medication and placebo on objective and self-rated performance during the Quantified Behavior Test in terms of the ADHD core signs hyperactivity, inattention and impulsivity in patients with untreated ADHD and Substance Use Disorders.
    Effekten av förväntning, aktivt läkemedel och placebo på objektiv och självskattad prestation vid Qb-test avseende ADHD kärnsymtomen hyperaktivitet, ouppmärksamhet och impulsivitet hos patienter med obehandlad ADHD och substanssyndrom.
    E.1.1.1Medical condition in easily understood language
    Effects of expectations, medication and placebo during the Quantified Behavior Test in patients with untreated ADHD and Substance Use Disorders.
    Effekten av förväntning, läkemedel och placebo på objektiv och självskattad prestation vid Qb-test hos patienter med obehandlad ADHD och substanssyndrom.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    To examine the effects of expectations, medication and placebo on objective and self-rated performance on ADHD core signs during the Quantified Behavior Test.
    Att undersöka effekterna av förvänting, läkemedel och placebo på objektiv och självskattad prestation på ADHD kärnsymtom vid Qb-test.
    E.2.2Secondary objectives of the trial
    not applicable
    inget
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years old or older.
    2. ADHD is diagnosed according to DSM-5 criteria.
    3. Substance use disorder is diagnosed according to DSM-5 criteria.
    4. Qb-score 1.3 or higher on any of the weighted summary parameters QbActivity, QbInAttention or QbImpulsivity on the
    Qb Test.
    5. Patients are given their written informed consent to participate in the study.
    1. 18 år eller äldre.
    2. ADHD diagnos enligt DSM-5 kriterier.
    3. Substanssyndrom enligt DSM-5 kriterier.
    4. Qb-poäng 1,3 eller högre på någon av de viktade parametrarna QbAktivitet, QbUppmärksamhet och QbImpulsivitet.
    5. Patienterna har lämnat skriftligt medgivande att delta i studien.
    E.4Principal exclusion criteria
    1. Affected by alcohol or drugs during the last month.
    2. Untreted severe comorbid psychiatric or somatic illness.
    3. Bloodpressure 150/95 or higher.
    4. Irregular pulse, or pulse 100 or higher.
    5. No counter indications according to the Medikinet pill.
    6. Concurrent clinical diagnossi that significantly could affect test performance.
    7. Concurrent prescription medicines for ADHD or medicines that significantly could affect test performance.
    1. Påverkand av alkohol eller droger under den senaste månaden.
    2. Obehandlad svår samsjuklighet, psykiatrisk eller somatisk sjukdom.
    3. Blodtryck höger eller lika med 150/95.
    4. Oregelbunden puls, eller puls högre eller lika med 100.
    5. Inga kontraindikationer till Medikinet.
    6. Samtidig klinisk diagnos som signifikant kan påverka testresultatet.
    7. Samtidig förskrivning ADHD-medicin eller läkemedel som kan påverka testresultatet.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variables are the weghted summary parameters QbActivity, QbInattention and QbImpulsivity on the Qb Test plus.
    Primära effektvariabler är de viktade parametrarna QbAktivitet, QbUppmärksamhet och Qbimpulsivitet på Qb Test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    December 2015
    December 2015
    E.5.2Secondary end point(s)
    Secondary outcome variables are self-rated scales concerning expected and experienced performance on the Qb Tes, help from the pill, and perceived severity on the tast.
    Sekundära effektvariabler är självskattningsskalor om förväntad och upplevd prestation på Qb Testet, erhållen hjälp av läkämedel samt upplevd svårighetsgrad på uppgiften.
    E.5.2.1Timepoint(s) of evaluation of this end point
    December 2015
    December 2015
    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 No
    E.6.4Safety No
    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 No
    E.8.1.6Cross over Yes
    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 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 years1
    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: 40
    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 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 state40
    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)
    Treatment as usual
    Sedvanlig behandling
    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 Decision2015-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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