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    Summary
    EudraCT Number:2016-002474-13
    Sponsor's Protocol Code Number:3.199
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002474-13
    A.3Full title of the trial
    Medication Optimization for ADHD: MOVA study
    Implementation and evaluation of double-blind placebo-controlled titration in clinical practice
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medication Optimization for ADHD: MOVA study

    A.3.2Name or abbreviated title of the trial where available
    Medication Optimization for ADHD: MOVA study
    A.4.1Sponsor's protocol code number3.199
    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 SponsorInnovatiefonds Zorgverzekeraars
    B.1.3.4CountryNetherlands
    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 supportInnovatiefonds Zorgverzekeraars
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Amsterdam Faculty of Behavioural and Movement Sciences Section Clinical Neorlopsychology
    B.5.2Functional name of contact pointKaren Vertessen
    B.5.3 Address:
    B.5.3.1Street Addressvan der Boechorststraat 1
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 BT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205985996
    B.5.6E-mailk.vertessen@vu.nl
    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 Information not present in EudraCT
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMethylphenidate HCL
    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 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
    E.1.1.1Medical condition in easily understood language
    ADHD
    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
    The primary purpose of this study is to investigate whether Placebo Controlled Titration (PCT) leads to an optimization of the use of MPH in clinical practice. The hypotheses are that:
    1.PCT is more sensitive in detecting placebo- and non-responders compared to stepwise titration. Therefore, the number of placebo- and non-responders that are detected will be higher in the PCT group;
    2.PCT leads to a more optimal dose, with better ADHD and ODD symptom reduction and less side effects, compared to stepwise titration;
    3.The maintenance dose is reached faster and with less pharmacological changes in the PCT group compared to stepwise titration.


    E.2.2Secondary objectives of the trial
    Secondary Objectives
    The second objective of this research is to develop a user-friendly titration method that will help therapists to make objective decisions about titration. We expect that:
    4. Parents’, teachers’ and therapists’ satisfaction about titration is higher in PCT compared to stepwise titration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    1.ADHD diagnosis according to the DSM-V criteria (all subtypes), by a therapist;
    2.Indication for treatment with short-acting MPH;
    3.Age between 6 and 12 years;
    4.Attending (any type of) primary school;
    5.Parents and teachers master the Dutch language to such a degree that they may read and understand the questionnaires that need to be filled out as part of the study.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    1.Counter-indication for the start-up of MPH. For example, MPH can be contraindicated in patients with Gilles de la Tourette, cardiac problems, or bipolar disorder.
    2.Treated with MPH in the last 6 months, in order to be able to evaluate the children's behavior over a period without medication at baseline (the start of the RCT).
    E.5 End points
    E.5.1Primary end point(s)
    Primary study parameter(s)
    The main hypotheses tested in this study are:

    1.The number of placebo- and non-responders that are detected will be higher in the PCT group. The main outcome measure to test this hypothesis is the proportion of children who continue MPH treatment after titration, measured both at T2 and T3, for each treatment condition. The proportion of children who continue treatment is determined by the number of children who are still being prescribed MPH at T2 or T3, divided by the total number of children who entered the trial in the respective treatment condition. Secondary analyses will evaluate whether the proportion of placebo- and non-responders is similar to previously reported numbers (e.g. by the MTA-study) by calculating the proportion of placebo- and non-responders within the PCT group.

    2.Children in the PCT group who continue treatment with MPH will be treated more optimally with MPH: they will show a greater reduction of ADHD and ODD behaviors, and have fewer side effects in comparison to the stepwise titration group. ADHD and ODD behaviors are assessed by the Disruptive Behavioral Rating Scale (Oosterlaan, Scheres, Antrop, Roeyers, & Sergeant, 2000) at baseline, T2, and T3. Both at T2 and T3, we will compare the reduction in symptoms over time (T2 or T3 minus baseline) between the two treatment groups. Side effects will be represented by the number and severity of side effects, as assessed by the side effect rating scale, and will be compared between the two treatment groups.

    3.The optimal (maintenance) dose is reached quicker in the PCT group compared to stepwise titration. At T2 and T3, the therapist will report on dose changes, and the currently used dose, in follow-up questionnaires. The maintenance dose is determined as the currently prescribed dose at T3. We will compare the two treatment groups for mean time needed (in days) to reach the maintenance dose, and the number of changes in the dose during the entire titration period (T1 - T3).





    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects wille be evalueted for primary end points at baseline 9T), after 8 weeks (T2) and after 6 months (T3).
    E.5.2Secondary end point(s)
    The secondary hypothesis tested in this study is that satisfaction with the titration method will be higher for PCT compared with stepwise titration for parents, teachers and therapists. For all informants, an aggregate score for satisfaction will be composed based on the satisfaction questionnaire. This score will be compared between the two treatment groups at T2 and T3. Additionally, results of the satisfaction questionnaires will be evaluated in a qualitative manner. Concerns and suggestions raised by parents, teachers and therapists will be discussed in the research team in order to optimize the use of PCT in clinical practice
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects wille be evalueted for secondary end points at baseline 9T), after 8 weeks (T2) and after 6 months (T3)
    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 Yes
    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 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
    The study is open for the titration methods, for teh PCT group the titration is double blind.
    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
    Other titration procedure.
    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 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
    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
    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: 160
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 140
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    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 state160
    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)
    None
    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 Decision2017-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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