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    Summary
    EudraCT Number:2017-000386-77
    Sponsor's Protocol Code Number:P140313
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-01-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-000386-77
    A.3Full title of the trial
    Effectiveness of Extended Release Methylphenidate in Reducing Cannabis Use in Young Cannabis-Dependent Patients with Attention Deficit Hyperactivity Disorder (ADHD)
    Efficacité du Méthylphénidate forme retard pour réduire la consommation de cannabis chez de jeunes patients présentant une dépendance au cannabis et un Trouble du Déficit de l'Attention Hyperactivité (TDAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of Extended Release Methylphenidate in Reducing Cannabis Use in Young Cannabis-Dependent Patients with Attention Deficit Hyperactivity Disorder (ADHD)
    Efficacité du Méthylphénidate forme retard pour réduire la consommation de cannabis chez de jeunes patients présentant une dépendance au cannabis et un Trouble du Déficit de l'Attention Hyperactivité (TDAH)
    A.3.2Name or abbreviated title of the trial where available
    METHACAN
    A.4.1Sponsor's protocol code numberP140313
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailelodie.soler@aphp.fr
    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 RITALINE L.P. 10 mg, gélule à libération prolongée
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRITALINE L.P. 10 mg, gélule à libération prolongée
    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 INNChlorhydrate de méthylphénidate
    D.3.9.3Other descriptive nameChlorhydrate de méthylphénidate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mg
    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: 2
    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 RITALINE L.P. 30 mg, gélule à libération prolongée
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRITALINE L.P. 30 mg, gélule à libération prolongée
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNChlorhydrate de méthylphénidate
    D.3.9.3Other descriptive nameChlorhydrate de méthylphénidate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30 mg
    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 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 RITALINE L.P. 10 mg, gélule à libération prolongée
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRITALINE L.P. 10 mg, gélule à libération prolongée
    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 INNChlorhydrate de méthylphénidate
    D.3.9.3Other descriptive nameChlorhydrate de méthylphénidate
    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: 4
    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 RITALINE L.P. 30 mg, gélule à libération prolongée
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS PHARMA SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRITALINE L.P. 30 mg, gélule à libération prolongée
    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 INNChlorhydrate de méthylphénidate
    D.3.9.3Other descriptive nameChlorhydrate de méthylphénidate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 2
    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
    Jeunes patients présentant une dépendance au cannabis et un Trouble du Déficit de l'Attention Hyperactivité (TDAH)
    E.1.1.1Medical condition in easily understood language
    Patients âgés de 12 à 25 ans, dépendants du cannabis, diagnostiqués TDAH, et pris en charge en addictologie.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10007177
    E.1.2Term Cannabis dependence
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L'objectif principal est d'évaluer l'efficacité à 12 semaines du traitement par Méthylphénidate forme retard versus placebo (en plus d'une prise en charge standardisée selon le P.A.A.C.T : Processus d'Accompagnement et d'Alliance pour le Changement Thérapeutique), sur la réduction du nombre de jours de consommation de cannabis chez des patients âgés de 12 à 25 ans, dépendants du cannabis, diagnostiqués TDAH, et pris en charge en addictologie.
    E.2.2Secondary objectives of the trial
    Objectifs secondaires :
    - Evaluer l'évolution du traitement par méthylphénidate retard à 4, 8 semaines et 12 mois, sur la réduction du nombre de jours de consommation de cannabis chez des patients âgés de 12 à 25 ans, dépendants du cannabis, diagnostiqués TDAH, et pris en charge en addictologie.

    - Evaluer l'efficacité à court et moyen termes (4, 8 et 12 semaines après le début du traitement) contre placebo et l'évolution à long terme (12 mois) du méthylphénidate forme retard sur :
    -- la consommation moyenne quotidienne de cannabis
    -- les symptômes du TDAH
    -- la dépendance à la nicotine
    -- le craving nicotinique
    - les comorbidités psychiatriques
    -- le fonctionnement global

    - Evaluer l'efficacité à moyen terme (12 semaines après le début du traitement) contre placebo et l'évolution à long terme (12 mois) du méthylphénidate forme retard sur :
    -- la dépendance au cannabis
    -- la consommation d'autres drogues (alcool, tabac, autres produits psychoactifs) et l'abus d'écrans.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > ou = 12 et < ou = 25 ans ;
    - Poids de 25 à 120 kg
    - TDAH diagnostiqué selon le critère DSM-V
    - Score au test ADHD-RS IV > ou = 28 ;
    - Sans traitement médicamenteux par méthylphénidate depuis au moins 6 mois ;
    - Absence de comorbidités psychiatriques associées à une contre-indication au traitement par methylphenidate (confirmé par MINI ou MINI Kid et auto-questionnaire de dépistage du trouble borderline MSI-BPD)
    - Dépendance au cannabis objectivée par un dosage urinaire qualitatif positif et un score > ou = 7 au questionnaire CAST avancé ;
    - Consentement des parents (enfant/adolescent < 18 ans) ou du jeune si âge > ou = 18 ans
    - Patientes en âge de procréer acceptant d'utiliser une méthode contraceptive efficace pendant la durée de l'essai
    E.4Principal exclusion criteria
    - Patients placés à l'aide sociale à l'enfance (ASE).
    - Patientes enceintes ou allaitantes
    - Non affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit)
    - Contre-indication au traitement par méthylphénidate;
    -- Hypersensibilité connue au méthylphénidate ou à l'un des excipients,
    -- Glaucome,
    -- Phéochromocytome,
    -- Traitement par les inhibiteurs irréversibles non sélectifs de la mono-amine-oxydase (IMAO) et également pendant au minimum 14 jours suivant l'arrêt du traitement par un IMAO en raison du risque de survenue de poussée hypertensive,
    -- Traitement par d'autres sympathomimétiques indirects ou des sympathomimétiques alpha (voies orale et/ou nasale)
    -- Hyperthyroïdie ou thyrotoxicose,
    -- Diagnostic ou antécédents de dépression sévère, anorexie mentale ou troubles anorexiques, tendances suicidaires, symptômes psychotiques, troubles de l'humeur sévères, manie, schizophrénie, trouble de la personnalité psychopathique ou limite (borderline),
    -- Diagnostic ou antécédents de trouble bipolaire (affectif) épisodique et sévère (de type 1) (et mal contrôlé),
    -- Troubles cardiovasculaires préexistants incluant hypertension sévère, insuffisance cardiaque, artériopathie occlusive, angine de poitrine, cardiopathie congénitale avec retentissement hémodynamique; cardiomyopathie, infarctus du myocarde, arythmies et canalopathies (troubles causés par un dysfonctionnement des canaux ioniques) pouvant potentiellement mettre en jeu le pronostic vital,
    -- Préexistence de troubles cérébrovasculaires, anévrisme cérébral, anomalies vasculaires, y compris vascularite ou accident vasculaire cérébral.
    E.5 End points
    E.5.1Primary end point(s)
    Nombre de jours de consommation de cannabis au cours des 21 derniers jours mesuré à 12 semaines par le TimeLine Follow Back (TLFB 21).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semaines
    E.5.2Secondary end point(s)
    1. le Nombre de jours de consommation de cannabis au cours des 21 derniers jours mesuré à l'inclusion 4, 8 semaines, et 12 mois par le TLFB 21.
    2. La quantité moyenne de consommation quotidienne de cannabis au cours des 21 derniers jours sera évaluée à partir du TLFB 21 à l'inclusion 4, 8, 12 semaines et 12 mois.
    3. Les symptômes du TDAH seront évalués à la pré-inclusion, l'inclusion, 4, 8 et 12 semaines et à 1 an en utilisant l'ADHD Rating Scale IV
    4. La dépendance au cannabis sera évaluée par deux outils différents :
    -A la pré-inclusion et à 1 an en utilisant l'échelle CAST avancée (Le Cannabis Abuse Screening Test)
    -A l'inclusion, 12 semaines et 1 an en utilisant l'échelle SDS (Severity of Dependence Scale)
    5. La dépendance à la nicotine sera évaluée à l'inclusion, 4, 8 et 12 semaines et à 1 an en utilisant :
    -The Hooked on nicotine checklist (HONC)
    -Le test CO : dosage " quantitatif " mesuré par un testeur de monoxyde de carbone
    6. Le craving nicotinique sera évalué à l'inclusion, 4, 8 et 12 semaines et à 1 an en utilisant le French version of the Tobacco Craving Questionnaire (FTCQ-12)
    7. Les comorbidités psychiatriques seront évaluées par autoquestionnaires à l'inclusion, 12 semaines et à 1 an en utilisant, selon la population :
    -CDI (patients mineurs) ou BDI (patients majeurs)
    -SPQ-BR
    8. La consommation d'autres drogues (alcool, tabac, autres produits psychoactifs) et l'abus d'écrans sera évaluée à l'inclusion, 12 semaines et à 1 an en utilisant :
    -le questionnaire ASSIST (Alcohol, smoking and substance involvement screening test).
    -un test urinaire de recherche qualitative de cannabis, opiacés, cocaïne, amphétamine, et benzodiazépine sera fait à J-10, à 12 semaines et à 1 an.
    -Le questionnaire PIUG 12
    9. Le fonctionnement global sera évalué à l'inclusion, 4, 8 et 12 semaines et à 1 an en utilisant 2 échelles différentes :
    -l'échelle d'amélioration clinique globale (CGI-S)
    -l'échelle du fonctionnement global (EGF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 8, 12 weeks and 12 months
    4, 8, 12 semaines et 12 mois
    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) 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) 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 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 concerned2
    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: 35
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    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 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 state70
    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 Decision2017-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-08
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