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    Summary
    EudraCT Number:2013-003731-29
    Sponsor's Protocol Code Number:WMTvsritalin
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2014-05-27
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-003731-29
    A.3Full title of the trial
    Could working memory training with computer games be an alternative to stimulant medication for children and adolescents with attention deficits and epilepsy?

    Arbeidsminnetrening m dataspill hos barn og unge med oppmerksomhetsvansker og epilepsi et alternativ til sentralstimulerende medikamenter?

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Could working memory training with computer games be an alternative to stimulant medication for children and adolescents with attention deficits and epilepsy?

    Arbeidsminnetrening m dataspill hos barn og unge med oppmerksomhetssvikt og epilepsi et alternativ til sentralstimulerende medikamenter?

    A.4.1Sponsor's protocol code numberWMTvsritalin
    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 SponsorSSE, Nevroklinikken, Oslo Universitetssykehus
    B.1.3.4CountryNorway
    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 supportForskningsnettverket fro ADHD og Tourettes
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSSE, Nevroklinikken, Oslo Universitetssykehus
    B.5.2Functional name of contact pointCharlotte Lunde, LiS, OUS
    B.5.3 Address:
    B.5.3.1Street AddressGF Henriksensvei 23
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0027
    B.5.3.4CountryNorway
    B.5.4Telephone number+4791186072
    B.5.6E-mailchalun@ous-hf.no
    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 Ritalin, Methylphenidate
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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
    Epilepsy and comorbid ADHD/ADD
    Epilepsi og komorbid ADHD/ADD
    E.1.1.1Medical condition in easily understood language
    Epilepsy and ADHD/ADD (attention deficit (hyperactivity) disorder)
    Epilepsi og ADHD/ADD (attention deficit hyperactivity disorder med eller uten hyperaktivitet)
    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
    The main objective of the trial is to evaluate if standardized and computerized workingmemory-training is as effective as traditional treatment (i.e stimulant medication/Methyphenidate) against ADHD symptoms in children and adolecents with attention deficits and epilepsy
    Primært endepunkt er å evaluere om standarisert arbeidsminnetrening med dataspill er like effektiv behandling som tradisjonell ADHD-behandling (sentralstimulerende medisiner/metylfenidat) mot ADHD -symptomer hos barn og unge med epilepsi og ADHD
    E.2.2Secondary objectives of the trial
    To assess if WMT improve executive function compared to baseline and to medicated group 12 weeks after inclusion.

    To assess if WMT influence on seizure-frequency and EEG-patterns compared to baseline
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    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    not applicable
    E.3Principal inclusion criteria
    9-15 years, known epilepsy, ADHD/ADD according to the current diagnostic criteria, boys and girls
    9-15 år, kjent epilepsi ADHD/ADD i hht gjeldende diagnosekriterer, gutter og jenter
    E.4Principal exclusion criteria
    Known depressive reaction/PTSD, more than two anti-epileptic drugs, diagnosis of moderate and severe mental retardation (F.71-F.79 or IQ below 55), medication under review, unstable seizure pattern, unstable life situation, contraindications for methylphenidate.
    Kjent depressiv reaksjon/PTSD, mer enn to antiepileptika, diagnose på moderat og alvorlig PU,
    medikamentomlegging, ustabil livssituasjon,ustabil anfallssituasjon, kontraindikasjoner for bruk av metylfenidat
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in workingmemory-tests 12 weeks from baseline in subjects receiving WM-training. The assessed improvement should be at least equal to the improvements in the medicated group.
    Bedring på arbeidsminnetester 12 uker etter baseline hos pasienter som har fått arbeidsminnetrening. Bedringen skal være minst like god som den i medisinert gruppe.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint for all endpoints would be 10-12 weeks after inclusion.
    Tidspunkt for evaluering av endepunkt vil være mellom 10 til 12 uker etter inklusjon.
    E.5.2Secondary end point(s)
    Improvements in parents and teachers questionnaire: BRIEF (Behavior Rating Inventory of executive function) and ADHD-rating-scale - compared to baseline.

    Does WM-training induce changes in quantified EEG (spike-activity and/or changes in theta/beta ratio) compared to baseline?
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    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of this evaluation will be the same as above; between 10-12 weeks after inclusion.
    se over
    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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    RoboMemo
    Computerized Working Memory Training "RoboMemo" by CogMed/Pearson Group
    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 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
    The last visit of the last subject is estimated to be in march 2017.
    se over
    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 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 Yes
    F.1.1Number of subjects for this age range: 46
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Both parents and the child will be asked to give their consent to participate in the study. If the child do not want to participate - even if the parents say yes they will not be included.
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    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 46
    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)
    Post-trial the group recieving stimulants/Ritalin will be offered the computerized working memory training game. After end of trial further follow up will be done at their local child and adolecent psychiatry- out patient clinic.
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    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Sørlandet Sykehus Arendal (SSA)
    G.4.3.4Network Country Norway
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-17
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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