Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004139-35
    Sponsor's Protocol Code Number:MNK14112096
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004139-35
    A.3Full title of the trial
    A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy
    Studio multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, a dose multipla, controllato con placebo, per valutare l’efficacia e la sicurezza di MNK-1411 in soggetti di sesso maschile di età compresa tra 4 e 8 anni affetti da distrofia muscolare di Duchenne
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial in Male Subjects with Muscular Disease
    Sperimentazione clinica in soggetti di sesso maschile con malattia muscolare
    A.3.2Name or abbreviated title of the trial where available
    Clinical Trial in Male Subjects with Muscular Disease
    Sperimentazione clinica in soggetti di sesso maschile con malattia muscolare
    A.4.1Sponsor's protocol code numberMNK14112096
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03400852
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorMALLINCKRODT ARD INC.
    B.1.3.4CountryUnited States
    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 supportMallinckrodt ARD Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMallinckrodt ARD Inc.
    B.5.2Functional name of contact pointClinical Trial Lead
    B.5.3 Address:
    B.5.3.1Street Address1425 Route 206
    B.5.3.2Town/ cityBedminster
    B.5.3.3Post codeNJ 07921
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019089979390
    B.5.5Fax number000000
    B.5.6E-mailLizelyn.Foley@mnk.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.3.1Product nameCosintropina acetato
    D.3.2Product code [MNK-1411]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETRACOSACTIDE ESACETATO
    D.3.9.1CAS number 22633-88-1
    D.3.9.2Current sponsor codeMNK-1411
    D.3.9.3Other descriptive nameCosyntropin acetate
    D.3.9.4EV Substance CodeSUB35804
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Synacthen Ampoules 250 mcg
    D.2.1.1.2Name of the Marketing Authorisation holderMallinckrodt Specialty Pharmaceuticals Ireland Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameSynacthen Ampoules 250 microgrammi
    D.3.2Product code [Synacthen Ampoules 250 microgrammi]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETRACOSACTIDE
    D.3.9.2Current sponsor codeSynacthen Ampoules
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Duchenne Muscular Distrophy
    Distrofia Muscolare di Duchenne
    E.1.1.1Medical condition in easily understood language
    Muscular Disease
    Malattia muscolare
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013801
    E.1.2Term Duchenne muscular dystrophy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of MNK-1411 on motor function in subjects with DMD.
    Determinare l’effetto di MNK-1411 sulla funzionalità motoria nei soggetti con DMD.
    E.2.2Secondary objectives of the trial
    1-To assess the effect of MNK-1411 on motor skills and strength.
    2-To determine the safety and tolerability of MNK-1411 in subjects with DMD.
    1- Valutare l'effetto di MNK-1411 sulle abilità motorie e sulla forza.
    2- Stabilire la sicurezza e la tollerabilità di MNK-1411 nei soggetti con DMD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria for inclusion in the study at the Screening Visit and at the Baseline Visit (except as noted):
    1. Each subject’s parent or legal guardian must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date on the ICF. In addition, each subject who is capable of understanding it must sign an assent form. The consent and assent (where applicable) for this study must be signed before any protocol required procedures are performed.
    2. Subjects must be male and between 4 and 8 years of age (inclusive) at the Screening Visit.
    3. Subjects must have a documented diagnosis of DMD confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as “out of frame”, or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.
    4. Subjects taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (eg, eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study
    5. Subjects should have serum potassium within the reference range at screening. Subjects who have potassium levels below the lower limit of normal may be given potassium supplements and then re-tested within the 28 day screening period.
    6. Subjects must test positive for exposure to varicella zoster virus on antibody testing. If subjects test negative, they may be vaccinated and re-tested.
    7. Subjects and/or subjects' parent or legal guardian must be able to communicate effectively with study personnel.
    8. Subjects and subjects' parent or legal guardian must be able and willing to follow all protocol requirements and study restrictions.
    9. Subjects and subjects' parent or legal guardian must be able and willing to return for all study visits.
    I soggetti devono soddisfare tutti i seguenti criteri di inclusione nello studio alla Visita di screening e alla Visita basale (ad eccezione di quanto specificato):
    1. Il genitore o tutore legale di ciascun soggetto deve essere adeguatamente informato e comprendere la natura e i rischi dello studio e deve essere in grado di apporre firma e data sul Modulo di consenso informato. Inoltre, ciascun soggetto che sia in grado di comprenderlo, deve firmare un modulo di assenso. Il consenso e l’assenso (laddove applicabile) alla partecipazione a questo studio devono essere firmati prima dell’esecuzione di qualsiasi procedura prevista dal protocollo.
    2. I soggetti devono essere di sesso maschile e avere un'età compresa tra 4 e 8 anni (inclusi) alla Visita di screening.
    3. I soggetti devono presentare una diagnosi documentata di DMD confermata da deficit di distrofina completa (attraverso immunofluorescenza e/o immunoblot) o mutazione identificabile del gene della DMD in cui lo schema di lettura può essere dichiarato come “fuori schema”, oppure sequenziamento del gene della distrofina completa coerente con DMD; E, a giudizio dello sperimentatore, un tipico profilo clinico coerente con DMD.
    4. I soggetti che assumono trattamenti per la DMD approvati (da parte di un’Autorità regolatoria) che hanno come target le mutazioni del gene della distrofina (ad es., eteplirsen o ataluren) potranno essere arruolati nello studio se hanno ricevuto trattamento con dose stabile per i 30 giorni precedenti la prima dose di farmaco in studio, e hanno in programma di continuare ad assumere tale dose nel corso dello studio.
    5. I soggetti dovranno presentare livelli di potassio nel siero all’interno dell’intervallo di riferimento allo screening. I soggetti che presentano livelli di potassio più bassi del limite inferiore della norma potranno ricevere integratori di potassio e successivamente ri-sottoporsi agli esami nel periodo di screening di 28 giorni.
    6. I soggetti devono risultare positivi all'esposizione al virus varicella zoster nel test sugli anticorpi. Se i soggetti risultano negativi, possono essere vaccinati e risottoposti al test.
    7. I soggetti e/o il genitore o tutore legale dei soggetti devono essere in grado di comunicare in modo efficace con il personale dello studio.
    8. I soggetti e/o il genitore o tutore legale dei soggetti devono essere in grado e voler rispettare tutti i requisiti del protocollo e le restrizioni dello studio.
    9. I soggetti e/o il genitore o tutore legale dei soggetti devono essere in grado e voler tornare per tutte le visite dello studio.
    E.4Principal exclusion criteria
    Subjects are ineligible for study participation if they meet any of the following criteria at the Screening Visit and at the Baseline Visit (except as note):
    1. Subject is from a vulnerable population (excluding pediatric populations), as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or family members of the research staff conducting the study, or of the sponsor, or of the clinical research organization, or of the IRB/IEC.
    2. Subject has had previous systemic treatment with corticosteroids. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. Inhaled corticosteroids will be permitted if given at a stable dose for the 3 months prior to the first dose of study drug and the subject will remain on that dose throughout the study. The use of topical or intra-articular corticosteroids is permitted during the study.
    3. Subject has been treated with immunosuppressants, or mineralocorticoids (including, but not limited to, spironolactone, eplerone, and carrenone) in the 3 months prior to the Screening Visit.
    4. Subject has taken any investigation medication within 30 days or 5 half lifes (whichever is longer) prior to the first dose of study drug.
    5. Subject is unwilling to receive, or is intolerant of, SC injections.
    6. Subject has symptomatic cardiomyopathy in the opinion of the investigator.
    7. Subject is unable to complete the 10 meter Walk/Run test in 10 seconds or less at the Screening and Baseline Visits.
    8. Subject has a history of any drug allergy, hypersensitivity, or intolerance to cosyntropin, H.P. Acthar® Gel or other ACTH products.
    Please refer to the protocol and synopsis for the complete list of exclusion criteria
    I soggetti non sono eleggibili per la partecipazione allo studio se soddisfano uno qualsiasi dei seguenti criteri alla Visita di screening e alla Visita basale (ad eccezione di quanto specificato):
    1. Il soggetto fa parte di una popolazione vulnerabile (esclusa la popolazione pediatrica), secondo la definizione del CFR Titolo 45, Parte 46, Sezione 46.111 (b) degli USA e altre normative nazionali e locali, inclusi, a titolo di esempio, dipendenti (temporanei, part-time, full-time, ecc.) o membri appartenenti alla famiglia dello staff di ricerca che conduce lo studio, o dello sponsor o dell’organizzazione di ricerca a contratto o dell’IRB/CEI.
    2. Il soggetto si era sottoposto a trattamento sistemico precedente con corticosteroidi. L’uso precedente transitorio di corticosteroidi sarà valutato caso per caso da parte dello sponsor o incaricato. I corticosteroidi per inalazione saranno ammessi se somministrati a una dose stabile per i 3 mesi precedenti la prima dose di farmaco in studio e il soggetto continua ad assumere tale dose nel corso dello studio. L’uso di corticosteroidi topici o per via intra-articolare è ammesso durante lo studio.
    3. Il soggetto è stato trattato con immunosoppressori o mineralocorticoidi (inclusi, a titolo di esempio, spironolattone, eplerone e carrenone) nei 3 mesi precedenti la Visita di screening.
    4. Il soggetto ha ricevuto qualsiasi farmaco sperimentale nei 30 giorni o 5 emivite (a seconda di quale sia il periodo più lungo) precedenti la prima dose di farmaco in studio.
    5. Il soggetto non è disposto a ricevere o è intollerante alle iniezioni SC.
    6. Il soggetto presenta cardiomiopatia sintomatica a giudizio dello sperimentatore.
    7. Il soggetto non è in grado di completare il test di 10 metri di corsa/camminata in 10 secondi o meno alla Visita di screening e alle Visite basali.
    8. Il soggetto presenta anamnesi di allergia, ipersensibilità al farmaco o intolleranza alla cosintropina, H.P. Acthar® Gel o altri prodotti a base di ACTH.
    9. Il soggetto presenta anamnesi o evidenza di infezione attiva o malattia febbrile nei 7 giorni precedenti la Visita di screening o il soggetto presenta infezione clinicamente significativa che richiede la somministrazione di antibiotici per via endovenosa o il ricovero ospedaliero nelle 4 settimane precedenti la Visita di screening o tra la Visita di screening e la prima dose di farmaco in studio.
    Si faccia riferimento al protocollo e alla sinossi per la lista completa dei criteri di esclusione
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in 10 meter walk/run time
    Variazione rispetto alla baseline del tempo impiegato per la corsa/camminata per 10 metri
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    settimana 24
    E.5.2Secondary end point(s)
    1-Change from baseline in quantitative muscle testing, the 4 Stair Climb, Time to Stand, and the North Star Ambulatory Assessment (NSAA); 2-Summary of general safety profile, including AEs, vital signs, height, weight, immunogenicity, and laboratory assessments over the entire study.
    1-Variazione rispetto alla baseline del test muscolare quantitativo, test di salita di 4 gradini, tempo per alzarsi e valutazione della deambulazione North Star (NSAA); 2-Sintesi del profilo di sicurezza generale, inclusi AE, funzioni vitali, altezza, peso, immunogenicità e valutazioni di laboratorio nel corso dell’intero studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-Week 24; 2-Over the entire study
    1- settimana 24; 2- Nel corso dell’intero studio
    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 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) 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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Costa Rica
    India
    Israel
    Mexico
    Puerto Rico
    Russian Federation
    Serbia
    Turkey
    Ukraine
    United States
    Bulgaria
    Ireland
    Italy
    Poland
    Spain
    United Kingdom
    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
    Last Follow-up visit:
    -Subjects who complete the study and do not enter the open label extension will have their Follow-up Visit at approximately Week 28.
    -Subjects who complete the open label extension will have their Follow-up Visit at Week 28 (± 7) Days After the Last Full Dose of Study Drug.
    Ultima visita di follow-up:
    -I soggetti che completano lo studio e non entrano nell’estensione in aperto si sottoporranno alla visita di follow-up indicativamente alla Settimana 28.
    -I soggetti che completano l'estensione in aperto avranno la Visita di follow-up alla Settimana 28 (± 7) giorni dopo l'ultima dose completa di farmaco in studio.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 132
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 132
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2018-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA