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    Summary
    EudraCT Number:2016-000215-32
    Sponsor's Protocol Code Number:Pycno2015-14
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-13
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000215-32
    A.3Full title of the trial
    Effect of Pycnogenol® on Attention-Deficit Hyperactivity Disorder (ADHD): A randomized, double blind, placebo and active product controlled multicenter trial.
    Effect van Pycnogenol® op Aandachtstekort Hyperactiviteitsstoornis (ADHD): een gerandomiseerde, dubbelblinde, placebo en actief product gecontroleerde multicenter studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Pycnogenol® on Attention-Deficit Hyperactivity Disorder (ADHD).
    Effect van Pycnogenol® op Aandachtstekort Hyperactiviteitsstoornis (ADHD).
    A.3.2Name or abbreviated title of the trial where available
    Effect of Pycnogenol® on ADHD.
    Effect van Pycnogenol® op ADHD.
    A.4.1Sponsor's protocol code numberPycno2015-14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02700685
    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 SponsorUniversity of Antwerp
    B.1.3.4CountryBelgium
    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 supportHorphag Research
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportUniversity of Antwerp
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Antwerp
    B.5.2Functional name of contact pointProf. Dr. Nina Hermans
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitsplein 1, building A (1.05)
    B.5.3.2Town/ cityWilrijk
    B.5.3.3Post code2610
    B.5.3.4CountryBelgium
    B.5.4Telephone number003232652706
    B.5.6E-mailannelies.verlaet@uantwerpen.be
    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 No
    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 namePycnogenol
    D.3.2Product code PYC
    D.3.4Pharmaceutical form Capsule
    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 INNPycnogenol
    D.3.9.1CAS number 174882-69-0
    D.3.9.2Current sponsor codePYC
    D.3.9.3Other descriptive namePROCYANIDIN
    D.3.9.4EV Substance CodeSUB78201
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typePycnogenol is marketed as a nutritional supplement, not as a medicine. It is a herbal extract, though regarded as an IMP in this clinical trial.
    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 Medikinet Retard
    D.2.1.1.2Name of the Marketing Authorisation holderMedice Arzneimittel Pütter GmbH & Co.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameMedikinet Retard
    D.3.4Pharmaceutical form Capsule, hard
    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 HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.2Current sponsor codeMPH
    D.3.9.3Other descriptive namemethylphenidate
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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 Retard
    D.2.1.1.2Name of the Marketing Authorisation holderMedice Arnzeimittel Pütter GmbH & Co.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameMedikinet Retard
    D.3.4Pharmaceutical form Capsule, hard
    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 HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.2Current sponsor codeMPH
    D.3.9.3Other descriptive namemethylphenidate
    D.3.9.4EV Substance CodeSUB03254MIG
    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 placeboCapsule
    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 (ADHD)
    ADHD
    E.1.1.1Medical condition in easily understood language
    ADHD: hyperactivity and/or low concentration
    ADHD: hyperactiviteit en/of gebrek aan concentratie
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003737
    E.1.2Term Attention deficit/hyperactivity disorder NOS
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10003736
    E.1.2Term Attention deficit/hyperactivity disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003735
    E.1.2Term Attention deficit-hyperactivity disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003734
    E.1.2Term Attention deficit disorder of childhood without mention of hyperactivity
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003733
    E.1.2Term Attention deficit disorder of childhood with hyperactivity
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003732
    E.1.2Term Attention deficit disorder of childhood
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003731
    E.1.2Term Attention deficit disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10003729
    E.1.2Term Attention concentration difficulty
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Pycnogenol® for improving ADHD and ADD behaviour as rated by parents as compared to placebo and Medikinet Retard.
    Het onderzoeken van het effect van Pycnogenol op ADHD of ADD gedrag beoordeeld door ouders, vergeleken met placebo en Medikinet Retard.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Pycnogenol® for improving ADHD and ADD behavior as rated by teachers as compared to placebo and Medikinet Retard.
    To evaluate the effect of Pycnogenol® as compared to placebo and Medikinet Retard on immunity, antioxidant levels, oxidative damage and comorbid psychiatric/physical complaints;
    To evaluate the tolerability of Pycnogenol®.
    Het onderzoeken van het effect van Pycnogenol op ADHD of ADD gedrag beoordeeld door leerkrachten, vergeleken met placebo en Medikinet Retard.
    Het beoordelen van de effecten van Pycnogenol, in vergelijking met placebo en Medikinet retard, op immuniteit, antioxidant status, oxidatieve schade, and co-morbide psychiatrische en fysieke klachten.
    Het beoordelen van de verdraagbaarheid van Pycnogenol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient is between 6-12 years old (both inclusive).
    The patient satisfies the DSM-IV criteria for ADHD or ADD.
    The patient does not have any contraindication for the use of methylphenidate.
    The patient has a responsible caregiver who is able to provide information about the patient’s functional status.
    Written informed consent is obtained from the patient and the legally accepted representative.
    De patiënt is 6-12 jaar oud (incl.).
    De patiënt beantwoordt aan de DSM-IV criteria voor ADHD of ADD.
    The patiërnt heeft geen contraindicatie voor het gebruik van methylfenidaat.
    De patiënt heeft een verantwoordelijke die informatie kan geven over de functionele status van de patiënt.
    Geschreven geïnformeerde toestemming is bekomen van de patiënt en zijn/haar wettelijke vertegenwoordiger.
    E.4Principal exclusion criteria
    The patient was diagnosed with autism spectrum disorder.
    The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ < 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt.
    The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome.
    The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills.
    The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days.
    The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) > 1 week during the 3 months before inclusion.
    De patiënt kreeg de diagnose van autisme spectrum stoornis.
    De patiënt heeft situationele hyperactiviteit, pervasieve ontwikkelingsstoornis, schizofrenie, andere psychotische aandoeningen zoals stemmings- of angststoornissen, persoonlijkheidsstoornis zoals asociaal egdrag, persoonlijkheidsverandering door een medische aandoening, mentale achterstand (IQ < 70), onderstimulerende omgeving, antisociale stoornis, chorea and andere dyskinesie. De patiënt heeft tics of het syndroom van Tourette, of persoonlijke of familiale geschiedenis van psychotische aandoeningen, bipolaire stoornis, depressie, of zelfmoordpoging.
    De patiënt heeft een chronische medische aandoening (diabetes, epilepsie of andere aanvalsstoornis, autoimmuunziekte, maagdarmstoornis, nier- of cardiovasculaire aandoening, etc.) of acute ontstekingsziekte. De patiënt heeft glaucoom, hartaandoening, hartritmestoornis, hoge bloeddruk, of perifere vasculaire aandoening zoals het syndroom van Raynaud.
    De patiënt heeft een of meerdere van deze medicaties gebruikt tijdens de drie maanden voorafgaan aan de studie: clonidine, guanethidine, bloedverdunners (bv. warfarine of Coumarine), antidepressiva, medicatie voor verkoudheden of allergie met decongestivum, medicatie voor hoge of lage bloeddruk, aanvalsmedicatie (bv. phenobarbital, phenytoin, primidone), of dieetpillen.
    De patiënt nam MAO remmer (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline of tranylcypromine) tijden de voorbije 14 dagen.
    De patiënt nam vitamine/mineralen/kruiden/omega-3 supplementen of enige andere medicatie (psychoactieve medicatie, antibiotica, ontstekingsremmende medicatie, melatonine, etc.) gedurende langer dan 1 week tijden de 3 maanden voorafgaan aan de studie.
    E.5 End points
    E.5.1Primary end point(s)
    Summed ADHD score of the ADHD-Rating Scale (ADHD-RS) as rated by parents.
    Totale ADHD-score van de ADHD-Rating Scale (ADHD-RS) zoals beoordeeld door ouders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 week, 10 weeks
    5 weken, 10 weken
    E.5.2Secondary end point(s)
    Summed ADHD score of the ADHD-RS as rated by teachers
    Summed ADHD score of the Social-Emotional Questionnaire (SEQ) as rated by parents & teachers
    Scores on ADHD subscales of the ADHD-RS and SEQ as rated by parents and teachers – hyperactivity, impulsivity and inattention
    Percentage of responders as rated by parents and teachers: Responders will be defined as participants with a reduction of at least 20% on their baseline summed ADHD score of the ADHD-RS.
    Social behavior problems subscale of the Social-Emotional Questionnaire (SEQ), as rated by parents and teachers
    Anxiety subscale of the Social-Emotional Questionnaire (SEQ), as rated by parents and teachers
    Physical and sleep complaints as measured by the Physical Complaints Questionnaire (PCQ)
    Erythrocyte glutathione (GSH) level: GSH is the most important intracellular antioxidant.
    Urinary 8-OHdG level: a marker of oxidative DNA damage.
    Plasma malondialdehyde (MDA) level: marker of in vivo oxidative lipid peroxidation.
    Immune profiling: Immune system activation state, skewing and responsivity will be assessed by the following determinations: determination of plasma cytokine levels for monocytes and T-cells as well as antibody levels.
    Gene expression quantification by RT-qPCR, focusing on gene and protein networks counteracting oxidative stress (GPX, CAT, SOD, XO) and stress-related proteins (Clusterin, Apolipoprotein J)
    Serum neuropeptide Y levels
    Serum zinc
    Plasma lipid soluble vitamins
    Urinary catecholamines
    Intestinal microbial composition
    Dietary habits
    Intervention acceptability
    Totale ADHD-score van de ADHD-RS, beoordeeld door leerkrachten
    Totale ADHD-score van de Sociaal-Emotionele vragenlijst (SEV), beoordeeld door ouders en leerkrachten
    Scoren op ADHD subschalen van de ADHD-RS en SEV, beoordeeld door ouders en leerkrachten: hyperactiviteit, impulsiviteit en concentratie.
    Percentage responders (vermindering totale ADHD-RS score van minstens 20%, beoordeeld door ouders en leerkrachten)
    Sociale gedragsproblemen subschaal van de SEV, beoordeeld door ouders en leerkrachten
    Angst subschaal van de SEV, beoordeeld door ouders en leerkrachten
    Fysieke en psychische klachten, gemeten door de Fysieke Klachten Vragenlijst
    Erytrocyten glutathione (GSH) niveau, de belangrijkste intracellulaire antioxidant
    Urine 8-OHdG niveau, een merker van oxidatieve schade aan DNA
    Plasma MDA niveau, een merker van in vivo oxidatieve schade aan vetten
    Immuunprofiel: immuun activatie, neiging, en responsiviteit door bepaling van plasma cytokine (monocyten en T cellen) en antilichaam niveau
    Genexpressie kwantificatie toor RT-qPCR, met de focus op genen tegen oxidatieve stress (GPX, CAT, SOD, XO) en stress-gerelateerde eiwitten (Clusterin, Apolipoprotein J)
    Serum neuropeptide Y niveau
    Serum zinc
    Plasma vetoplosbare vitaminestatus
    Urinair catecholamine niveau
    Intestinale microbiële samenstelling
    Voedingsgewoonten
    Aanvaardbaarheid van de interventie
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 weeks
    10 weken
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LBLP
    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 months6
    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: 144
    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: 130
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    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 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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children between 6 and 12 years old
    Kinderen tussen 6 en 12 jaar oud
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    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 different from standard care in case of ADHD/ADD.
    Niet verschillend van de standaardbehandeling in geval van ADHD/ADD.
    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 Decision2016-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-11-20
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