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    The EU Clinical Trials Register currently displays   37733   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000206-36
    Sponsor's Protocol Code Number:DOPA1
    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:2014-05-28
    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 number2014-000206-36
    A.3Full title of the trial
    DRD4 genotype as a moderator of L-Dopa intervention effects on parent-related neurocognitive processes, behaviors, and attitudes: A micro-trial of differential susceptibility to pharmacological intervention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Differential susceptibility to L-Dopa in caregiving
    A.3.2Name or abbreviated title of the trial where available
    Differential susceptibility to L-Dopa in caregiving
    A.4.1Sponsor's protocol code numberDOPA1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Sinemet
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme BV
    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 nameSinemet
    D.3.2Product code RVG 08740
    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
    There are no medical conditions or diseases under investigation.
    E.1.1.1Medical condition in easily understood language
    not applicable
    E.1.1.2Therapeutic area Not possible to specify
    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
    We aim to investigate whether the dopamine receptor D4 (DRD4) genotype confers differential susceptibility to the effects of early life stress, on caregiving behavior in adults. We also aim to study whether DRD4 genotype and resting frontal asymmetry confer differential susceptibility to effects of a dopaminergic pharmacological intervention on caregiving-related neurocognitive processes, behaviors, and attitudes. The following questions will be addressed:
    1. What is the relationship between DRD4 genotype and adult empathy and prosocial behavior, and does early life experience moderate this effect?
    2. What is the effect of L-Dopa administration (a pharmacological intervention that heightens levels of dopamine) on parenting-related neurocognitive processes, behaviors, and attitudes?
    3. Does the DRD4 genotype moderate the efficacy of the pharmacological intervention?
    4. Can resting frontal asymmetry serve as an endophenotype for differential susceptibility?
    E.2.2Secondary objectives of the trial
    Rigorous statistical probing will be conducted, including the use of simulations to test the integrity of the data. Results of these statistical assessments will be used to correct the data accordingly. These analyses will help to improve the quality of data-analysis and conclusions, and provide statistical guidelines for future data-analysis of similar designs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    healthy, female, 18 years old or older, of caucasian descent
    E.4Principal exclusion criteria
    pregnancy, breastfeeding, drug or alcohol abuse, prior psychiatric or neurological disorder,use of medication (except oral contraceptives), existing medical condition
    E.5 End points
    E.5.1Primary end point(s)
    -Theory of Mind. An adult version of the Reading the Mind in the Eyes Test will be carried out, to determine the baseline level of interpretation of emotion.
    -Prosociality.
    - Resting frontal asymmetry. Participants’ resting EEG will be recorded and an asymmetry index will be computed (see below). As described above, we will investigate whether resting frontal alpha asymmetry can be considered an endophenotype for differential susceptibility.
    - Neural indices of the processing of and attention to infant faces and sounds. ERP components indicative of processing depth and attention will be computed from the EEG recorded while participants listen to infant sounds and view infant faces (see below). EEG asymmetry in response to faces and sounds, as a measure of approach-withdrawal responses to these stimuli, will also be computed (see below). We will study effects of L-Dopa on these neural indices, and investigate whether L-Dopa effects are moderated by the DRD4 genotype and resting frontal asymmetry. In addition, we will investigate whether changes in neural indices after L-Dopa administration mediate changes in behavioral measures (sensitivity, interpretation of infant cues, caregiving attitudes, empathy).
    - Cardiac indices of arousal in response to infant faces and sounds. Cardiac indices indicating sympathetic and parasympathetic activity will be computed from the ECG and ICG recorded while participants listen to infant sounds and view infant faces (see below). We will study effects of L-Dopa on these neural indices, and investigate whether L-Dopa effects are moderated by the DRD4 genotype and resting frontal asymmetry. In addition, we will investigate whether changes in cardiac indices after L-Dopa administration mediate changes in behavioral measures (sensitivity, interpretation of infant cues, caregiving attitudes, empathy).
    -Mirror-neuron activity. Mirror-neuron activity will be studied using measures derived from the EEG (see below). We will investigate whether potential effects of L-Dopa on these measures are moderated by the DRD4 genotype and resting frontal asymmetry. In addition, we will investigate whether changes in mirror-neuron activity after L-Dopa administration mediate changes in behavioral measures (sensitivity, interpretation of infant cues, caregiving attitudes, empathy).
    - Sensitivity of caregiving behaviour. The Leiden Infant Simulator Assessment will be used to measure participants’ sensitivity (see below). We will investigate investigate whether potential effects of L-Dopa on sensitivity are moderated by the DRD4 genotype and resting frontal asymmetry.
    - Interpretation of infant cues. An infant-face version of the Reading the Mind in the Eyes Test will be used to measure participants’ interpretation of infant cues (see below). We will study effects of L-Dopa on this measure, and investigate whether L-Dopa effects are moderated by the DRD4 genotype and resting frontal asymmetry.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will come to the laboratory for two identical experimental sessions, separated by 4 weeks.
    E.5.2Secondary end point(s)
    - Self-reported caregiving attitudes and empathy. We will investigate whether L-Dopa administration affects questionnaire measures (see below) of empathy and caregiving attitudes, and whether potential effects are moderated by genotype and resting frontal asymmetry.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary parameters will be assessed during the same two identical experimental sessions, separated by 4 weeks.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    We aim to investigate whether the dopamine receptor D4 (DRD4) genotype confers differential susceptibility to the effects of early life stress, on caregiving behavior in adults. We also aim to study whether DRD4 genotype and resting frontal asymmetry confer differential susceptibility to effects of a dopaminergic pharmacological intervention on caregiving-related neurocognitive processes, behaviors, and attitudes.
    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 trial1
    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
    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 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: 200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-05-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    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)
    Not applicable, all subjects are healthy adult volunteers, there's no medical condition under investigation.
    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 Decision2014-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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