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    Summary
    EudraCT Number:2017-002176-75
    Sponsor's Protocol Code Number:CZPL389A2203
    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:2019-11-04
    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 number2017-002176-75
    A.3Full title of the trial
    A randomized, double blind, placebo controlled multicenter dose ranging study to assess the safety and efficacy of multiple oral ZPL389 doses in patients with moderate to severe Atopic Dermatitis (ZEST trial)
    Etude dose-réponse, multicentrique, randomisée, en double aveugle, contrôlée par placebo, évaluant la tolérance et l’efficacité de doses multiples de ZPL389 par voie orale chez des patients atteints de dermatite atopique modérée à sévère (étude ZEST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and efficacy of ZPL389 doses in subjects with moderate to severe atopic dermatitis
    Etude évaluant la tolérance et l’efficacité de doses multiples de ZPL389 chez des patients atteints de dermatite atopique modérée à sévère
    A.3.2Name or abbreviated title of the trial where available
    A study to assess the safety and efficacy of ZPL389 doses in patients with moderate to severe AD
    A.4.1Sponsor's protocol code numberCZPL389A2203
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address8/10 rue Henry Sainte Claire Deville, CS 40150
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92563
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 5547 6600
    B.5.5Fax number+33 1 5547 6100
    B.5.6E-mailicm.phfr@novartis.com
    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.3.2Product code ZPL389
    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 INNadriforant
    D.3.9.1CAS number 2096455-87-5
    D.3.9.2Current sponsor codeZPL389
    D.3.9.3Other descriptive nameZPL-3893787
    D.3.9.4EV Substance CodeSUB179385
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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.3.2Product code ZPL389
    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 INNadriforant
    D.3.9.1CAS number 2096455-87-5
    D.3.9.2Current sponsor codeZPL389
    D.3.9.3Other descriptive nameZPL-3893787
    D.3.9.4EV Substance CodeSUB179385
    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 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.3.2Product code ZPL389
    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 INNadriforant
    D.3.9.1CAS number 2096455-87-5
    D.3.9.2Current sponsor codeZPL389
    D.3.9.3Other descriptive nameZPL-3893787
    D.3.9.4EV Substance CodeSUB179385
    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.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 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.3.2Product code ZPL389
    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 INNadriforant
    D.3.9.1CAS number 2096455-87-5
    D.3.9.2Current sponsor codeZPL389
    D.3.9.3Other descriptive nameZPL-3893787
    D.3.9.4EV Substance CodeSUB179385
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, hard
    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
    Moderate to severe atopic dermatitis
    Dermatite atopique modérée à sévère
    E.1.1.1Medical condition in easily understood language
    Inflammation of the skin resulting in itchy, red, swollen and cracked skin.
    Inflammation de la peau entraînant des démangeaisons, des rougeurs, des gonflements et craquèlement de la peau.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the dose-response relationship of ZPL389 in patients with moderate to severe AD assessed by Investigator's global assessment (IGA) response at week 16 .
    Caractériser la relation dose-réponse de ZPL389 chez des patients atteints de dermatite atopique (DA) modérée à sévère, mesurée par l’évaluation globale du médecin-investigateur (IGA) à la Semaine 16.
    E.2.2Secondary objectives of the trial
    • To characterize the dose-response relationship of ZPL389 in patients with moderate to severe AD assessed using the percent change from baseline in Eczema Area and Severity Index (EASI) score after 16 weeks of treatment
    • To evaluate the efficacy across different dose levels as assessed by EASI and IGA compared to placebo over time
    • To assess the safety and tolerability of different doses of ZPL389 as compared to placebo
    • Caractériser la relation dose-réponse de ZPL389 chez des patients atteints de DA modérée à sévère, mesurée par le pourcentage de variation par rapport à la baseline du score EASI (EASI pour Eczema Area and Severity Index) après 16 semaines de traitement
    • Evaluer l’efficacité des différentes doses de ZPL389 testées, en utilisant les scores IGA et EASI, comparées au placebo au cours du temps
    • Evaluer la sécurité d’emploi et la tolérance à différentes doses de ZPL389 par rapport au placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Actigraphy substudy
    Objective: Explore the effect of ZPL389 on sleep disturbance and nocturnal scratching in a subset of subjects.

    Optional tape strips sub-study was added to assess biomarkers and molecular pathways related to disease from superficial skin layers.
    Titre: Sous-étude d’actigraphie
    Objectif : Explorer l’effet de ZPL389 sur la perturbation du sommeil et le grattage nocturne dans un sous-groupe de patients.

    Une sous-étude optionnelle a été ajoutée pour évaluer des biomarqueurs et des voies de signalisation moléculaire relatives à la maladie dans des échantillons de couches cutanées superficielles prélevées par des bandes adhésives.
    E.3Principal inclusion criteria
    Eligible for inclusion in this study must fulfill all of the following criteria:
    - Written informed consent
    - Females and males aged 18 years or older
    - Chronic atopic dermatitis (according to AADConsensus Criteria), that has been present for at least 1 year before the Baseline visit.
    - Moderate to severe atopic dermatitis defined as:
     - Eczema Area and Severity Index ≥16 at Screening and at Baseline
     - Investigator's global assessment 3 or 4 on a 5-point scale at screening and Baseline
     - Body Surface Area involvement ≥10% at Screening and Baseline
    - Average peak pruritis score ≥3 as assessed by NRS over the last 7 days prior to Baseline
    - Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks)
    - Candidate for systemic treatment
    - Have applied a stable dose of bland topical emollient at least once daily for at least the 7 consecutive days immediately before the baseline visit
    Pour l’inclusion dans l’étude, les patients doivent remplir tous les critères suivants :
    - Le consentement éclairé doit être obtenu par écrit
    - Patients de sexe masculin ou féminin âgés de 18 ans et plus
    - Patients atteints de dermatite atopique chronique, selon les critères de la Société américaine de Dermatologie (American Academy of Dermatology Consensus Criteria), depuis au moins 1 an avant la visite de baseline.
    - Dermatite atopique modérée à sévère, telle que définie par :
    • Score EASI ≥ 16 à la sélection et à la baseline
    • Score IGA de 3 ou 4 sur une échelle de 5 à la sélection et à la baseline
    • ≥ 10 % de la surface corporelle atteinte à la sélection et à la baseline (BSA)
    - Intensité maximale moyenne du prurit selon l’échelle d’évaluation numérique (NRS pour Numerical rating scale) ≥ 3 au cours des 7 jours précédant la baseline.
    - Antécédents récents documentés (dans les 6 mois précédant la visite de sélection) de réponse inadéquate au traitement topique de la dermatite atopique ou patients pour qui les traitements topiques sont déconseillés pour des raisons médicales (par ex. à cause d’effets indésirables importants).
    - Patient candidat à un traitement systémique.
    - Patient ayant appliqué une dose stable d’émollients une fois par jour pendant au moins les 7 jours précédant la visite de la baseline.

    E.4Principal exclusion criteria
    - Any skin disease that, in the opinion of the investigator, including infection, would confound the diagnosis or evaluation of atopic dermatitis disease activity
    - Current active skin infection at Baseline
    - Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days /until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
    - History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
    - subjects taking prohibited medication as per protocol
    - Risk factors for Torsades de Pointe including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia or any of the following:
     - Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome
     - Concomitant medication(s) with a “Known Risk of Torsades de Pointe” that cannot be discontinued or replaced by safe alternative medication.
    - Resting QTcF ≥450 msec (male) or ≥470 msec (female) at screening or baseline or inability to determine the QTcF interval
    - Cardiac or cardiac repolarization abnormality
    - Subjects with pre-existing conditions that may confound ability to diagnose drug-induced liver injury or subjects with factors that increase susceptibility to DILI
    - Subjects who have a laboratory abnormality at Screening
    - History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
    - Past medical history record of, or current infection with, human immunodeficiency virus
    - Any surgical, medical, psychiatric or additional physical condition that the Investigator feels may jeopardize the subject in case of participation in this study
    - Pregnant or nursing (lactating) women
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using required methods of contraception during dosing and for 4 weeks after stopping of investigational medication.
    - Sexually active males unless they use a condom during intercourse while taking drug and for 120 days after stopping investigational medication and should not father a child in this period.
    - Prior exposure to ZPL389 treatment
    - Toute maladie de la peau qui, selon le médecin-investigateur, pourrait interférer avec le diagnostic ou l’évaluation de l’activité de la dermatite atopique
    - Infection cutanée active à la baseline
    - Utilisation de tout autre traitement expérimental dans les 30 jours précédant l’inclusion, ou 5 demi-vies de ce traitement avant l’inclusion, ou jusqu’à ce que l’effet pharmacodynamique attendu soit revenu à la baseline, selon la durée la plus longue.
    - Antécédents d’hypersensibilité à tout composant du traitement à l’étude ou à d’autres traitements de mêmes classes thérapeutiques.
    - Patients recevant des traitements non autorisés par le protocole
    - Facteurs de risques de Torsades de Pointes, y compris une hypokaliémie ou une hypomagnésémie non corrigée, des antécédents d’insuffisance cardiaque, des antécédents de bradycardie cliniquement significative ou symptomatique, ou tout autre facteur tel que :
    • Syndrome du QT long, antécédents familiaux de mort subite idiopathique ou syndrome du QT long congénital
    • Traitement concomitant par un ou plusieurs médicaments présentant un risque connu de Torsades de Pointes qui ne peuvent pas être interrompus ou remplacés par une alternative plus sûre
    - Intervalle QT corrigé par la formule de Fridericia (QTcF) au repos ≥ 450 msec (hommes) ou ≥ 470 msec (femmes) à la sélection ou à la baseline ou instabilité ne permettant pas de déterminer l’intervalle QTcF.
    - Troubles de la repolarisation ou toute autre anomalie cardiaque
    - Patients atteints de troubles préexistants qui pourraient interférer avec le diagnostic d’une lésion hépatique d’origine médicamenteuse ou ayant des facteurs qui augmentent le risque de lésions hépatiques d’origine médicamenteuse
    - Patients ayant des anomalies biologiques à la sélection
    - Antécédents de maladie lymphoproliférative, présence connue d’une tumeur maligne ou antécédents de toute tumeur maligne au cours des 5 années précédentes
    - Antécédents connus d’infection ou infection en cours par le virus de l’immunodéficience humaine (VIH)
    - Tout problème médical, chirurgical, psychiatrique ou autre qui, selon le médecin-investigateur pourrait compromettre la sécurité du patient en cas de participation à l’étude.
    - Femmes enceintes ou qui allaitent.
    - Femmes en âge d’avoir des enfants, c’est-à-dire toutes les femmes physiologiquement aptes à être enceintes, sauf si elles utilisent une méthode de contraception très efficace pendant toute la période de traitement et les 4 semaines qui suivent l’arrêt du traitement à l’étude.
    - Les hommes ayant des rapports sexuels doivent accepter d’utiliser un préservatif pendant les rapports sexuels au cours de la période de traitement et pendant les 120 jours qui suivent l’arrêt du traitement à l’étude et de ne pas concevoir d’enfant pendant cette période.
    - Exposition antérieure à ZPL389.
    E.5 End points
    E.5.1Primary end point(s)
    IGA response at Week 16
    Réponse IGA à la Semaine 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    Semaine 16
    E.5.2Secondary end point(s)
    • Percent change from baseline EASI score at Week 16
    • At each visit:
    • IGA score
    • IGA response
    • EASI score as well as absolute and percent change from baseline EASI score
    • EASI 50 response, EASI 75 response
    • Frequency of adverse events
    • Pourcentage de variation du score EASI à la Semaine 16 par rapport à la baseline
    • A chaque visite :
    • Score IGA
    • Réponse IGA
    • Score EASI (valeur absolue et pourcentage de variation par rapport à la baseline)
    • Réponses EASI-50, EASI-75
    • Fréquence des évènements indésirables
    E.5.2.1Timepoint(s) of evaluation of this end point
    At visits in week 0, 2, 4, 6, 8, 12, 16
    Lors des visites semaine 0, 2, 4, 6, 8, 12, 16
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Actigraphy Substudy :
    A subset of approximately 100-150 subjects will participate in a substudy to measure movement during sleep.
    Sous-étude d’actigraphie:
    Un sous-groupe d’environ 100 à 150 patients participera à une sous-étude visant à mesurer les mouvements pendant le sommeil.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial5
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Belgium
    Canada
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hungary
    Iceland
    Japan
    Latvia
    Lithuania
    Netherlands
    Poland
    Russian Federation
    Slovakia
    Spain
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 360
    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)
    Subjects may be offered participation on an extension study
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-08-07
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