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    Summary
    EudraCT Number:2017-000146-21
    Sponsor's Protocol Code Number:AT1001-020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-10-23
    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 number2017-000146-21
    A.3Full title of the trial
    AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS
    Studio in aperto volto a valutare la sicurezza, la farmacocinetica, la farmacodinamica e l’efficacia di un trattamento di 12 mesi con migalastat in soggetti pediatrici (età compresa tra 12 e <18 anni) con malattia di Fabry e varianti suscettibili del gene GLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABLE GLA VARIANTS
    Studio in aperto volto a valutare la sicurezza, la farmacocinetica, la farmacodinamica e l’efficacia di un trattamento di 12 mesi con migalastat in soggetti pediatrici (età compresa tra 12 e <18 anni) con malattia di Fabry e varianti suscettibili del gene GLA
    A.3.2Name or abbreviated title of the trial where available
    ASPIRE
    ASPIRE
    A.4.1Sponsor's protocol code numberAT1001-020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03500094
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/328/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmicus Therapeutics UK, Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportAmicus Therapeutics, UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmicus Therapeutics, Inc
    B.5.2Functional name of contact pointPatient Advocacy
    B.5.3 Address:
    B.5.3.1Street Address1 Cedar Brook Drive
    B.5.3.2Town/ cityCranbury
    B.5.3.3Post codeNJ 08512
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016096622000
    B.5.5Fax number0016096625010
    B.5.6E-mailclinicaltrials@amicusrx.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 Yes
    D.2.1.1.1Trade name Galafold
    D.2.1.1.2Name of the Marketing Authorisation holderAmicus Therapeutics UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberE/3/06/368
    D.3 Description of the IMP
    D.3.1Product nameMigalastat
    D.3.2Product code [AT1001]
    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 INNmigalastat
    D.3.9.1CAS number 75172-81-5
    D.3.9.2Current sponsor codeAT1001
    D.3.9.3Other descriptive nameMIGALASTAT HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fabry disease and with amenable GLA variants
    malattia di Fabry e varianti suscettibili del gene GLA
    E.1.1.1Medical condition in easily understood language
    Fabry's disease
    malattia di Fabry
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016016
    E.1.2Term Fabry's disease
    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
    Stage 1:
    • to characterize the PK of migalastat in adolescents with Fabry disease and to validate extrapolation of migalastat plasma exposure in adults to adolescents weighing = 45 kg for the 150 mg migalastat capsule administered every other day (QOD)
    • to evaluate the safety of migalastat treatment in pediatric subjects diagnosed with Fabry disease and who have variants in the gene encoding a galactosidase A (a Gal A) (GLA) amenable to treatment with migalastat
    Stage 2:
    • to evaluate the safety of migalastat treatment in pediatric subjects diagnosed with Fabry disease and who have GLA variants amenable to treatment with migalastat
    Parte 1
    - caratterizzare la farmacocinetica (PK) di migalastat in adolescenti con malattia di Fabry e convalidare l’estrapolazione dell’esposizione plasmatica a migalastat in adulti e adolescenti con peso = 45 kg trattati con capsule di migalastat, 150 mg, somministrate a giorni alterni (QOD)
    - valutare la sicurezza del trattamento con migalastat in soggetti pediatrici con diagnosi di malattia di Fabry e varianti del gene codificante per a galattosidasi A (a Gal A) (GLA) suscettibili al trattamento con migalastat
    Parte 2
    - Valutare la sicurezza del trattamento con migalastat in soggetti pediatrici con diagnosi di malattia di Fabry e varianti del gene GLA suscettibili al trattamento con migalastat
    E.2.2Secondary objectives of the trial
    • to characterize the pharmacodynamics (PD) of migalastat in pediatric subjects diagnosed with Fabry disease and who have GLA variants amenable to treatment with migalastat
    • to evaluate the efficacy of migalastat in pediatric subjects diagnosed with Fabry disease and who have GLA variants amenable to treatment with migalastat
    • to evaluate the relationship between exposure to migalastat and response
    • caratterizzare la farmacodinamica (PD) di migalastat in soggetti pediatrici con diagnosi di malattia di Fabry e varianti del gene GLA suscettibili al trattamento con migalastat
    • valutare l'efficacia di migalastat in soggetti pediatrici con diagnosi di malattia di Fabry e varianti del gene GLA suscettibili al trattamento con migalastat
    • valutare la relazione tra l'esposizione a migalastat e la risposta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.have a parent or legally-authorized representative who is willing and able to provide written informed consent and authorization for use and disclosure of personal health information or research-related health information, and subject provides assent, if applicable
    2. male or female, diagnosed with Fabry disease aged between 12 and < 18 years at baseline, and who might benefit from specific treatment for their condition, in the opinion of the investigator
    3. confirmed amenable GLA variant determined using the migalastat amenability assay
    4. weight of = 45 kg (99 pounds) at screening
    5. treatment-naïve or discontinued ERT treatment at least 14 days prior to screening
    6. have at least one complication (ie, historical or current laboratory abnormality and/or sign/symptom) of Fabry disease
    7. able to swallow capsules
    8. if of reproductive potential, agree to use medically accepted methods of contraception throughout the duration of the study and for up to 30 days after last dose of study medication
    1. avere un genitore o un legale rappresentante che è in grado di fornire un consenso informato scritto e l’autorizzazione all’uso e alla divulgazione dei dati medici del soggetto o dei dati medici inerenti la ricerca; inoltre, ove previsto, il soggetto deve fornire il proprio assenso
    2. essere di sesso maschile o femminile con diagnosi di malattia di Fabry ed età compresa tra 12 e <18 anni al basale e poter trarre beneficio da un trattamento specifico per la propria condizione, secondo il parere dello sperimentatore
    3. variante di GLA suscettibile confermata mediante l'analisi di suscettibilità a migalastat
    4. peso =45 kg allo screening
    5. essere naïve al trattamento ERT, oppure averlo interrotto almeno 14 giorni prima dello screening
    6. presentare almeno una complicanza (ossia, anomalia nei test di laboratorio e/o segni/sintomi pregressi o attuali) della malattia di Fabry
    7. essere in grado di deglutire capsule
    8. se in grado di procreare, acconsentire all'uso di metodi contraccettivi clinicamente approvati per la durata dello studio e fino a 30 giorni dopo l'ultima dose del farmaco in studio
    E.4Principal exclusion criteria
    1. moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m2 at screening)
    2. advanced kidney disease requiring dialysis or kidney transplantation
    3. history of allergy or sensitivity to migalastat (including excipients) or other iminosugars (eg, miglustat, miglitol)
    4. subject has received any gene therapy at any time or anticipates starting gene therapy during the study period
    5. requires treatment with Glyset® (miglitol) or Zavesca® (miglustat), within 6 months before screening or throughout the study
    6. requires treatment with Replagal® (agalsidase alfa) or Fabrazyme® (agalsidase beta) within 14 days before screening or throughout the study
    7. received any investigational/experimental drug, biologic or device within 30 days before screening
    8. any intercurrent illness or condition at screening or baseline that may preclude the subject from fulfilling the protocol requirements or suggests to the investigator that the potential subject may have an unacceptable risk by participating in this study
    9. is pregnant or breast-feeding, or is planning to become pregnant during the study period
    10. in the opinion of the investigator, the subject and/or parent or legally authorized representative is unlikely or unable to comply with the study requirements
    1. compromissione renale moderata o grave (eGFR <60 ml/min/1,73 m2 allo screening)
    2. malattia renale avanzata con necessità di dialisi o trapianto di rene
    3. anamnesi di allergia o sensibilità a migalastat (inclusi gli eccipienti) o ad altri iminozuccheri (ad es. miglustat, miglitol)
    4. il soggetto è stato trattato con terapia genica in qualunque momento o prevede l’inizio di una terapia genica durante il periodo dello studio
    5. necessità di trattamento con Glyset® (miglitol) o Zavesca® (miglustat) nei 6 mesi precedenti allo screening o durante lo studio
    6. necessità di trattamento con Replagal® (alfa-agalsidasi) o Fabrazyme® (beta-agalsidasi) nei 14 giorni precedenti allo screening o nel corso dello studio
    7. assunzione di farmaci in studio/sperimentali o impiego di dispositivi medici o farmaci biologici nei 30 giorni precedenti allo screening
    8. qualsiasi malattia o condizione intercorrente allo screening o al basale che possa impedire al soggetto di adempiere i requisiti del protocollo o indurre lo sperimentatore a ritenere che la partecipazione allo studio possa esporre il potenziale soggetto a un rischio inaccettabile
    9. gravidanza, allattamento al seno o pianificazione di una gravidanza durante il periodo dello studio
    10. improbabilità o impossibilità, secondo il parere dello sperimentatore, che il soggetto e/o genitore, o rappresentante legale autorizzato si attenga ai requisiti dello studio
    E.5 End points
    E.5.1Primary end point(s)
    1. incidence of TEAEs, SAEs, and AEs leading to discontinuation of study drug
    2. changes in clinical laboratory test results
    3. changes in vital signs
    4. changes in physical examination findings
    5. change in body weight and height percentile
    6. changes in ECG results
    7. changes in echocardiogram parameters
    8. change in Tanner stage
    9. use of concomitant medications
    10. population pharmacokinetics (popPK) model that describes the relationship between weight and age and migalastat pharmacokinetics in pediatric subjects
    11 .popPK: Cmax :maximum observed plasma concentration
    12. popPK: Cmin : minimum observed plasma concentration
    13. popPK: tmax : time to reach Cmax
    14. popPK: AUC0-T: area under the plasma concentration-time curve from time 0 over the dosing interval (ie, 48 hours)
    15. popPK: t½ : terminal elimination half-life
    16. popPK: CLss/F : apparent oral clearance at steady-state concentration
    17. popPK: Vss/F concentration: apparent oral volume of distribution at
    steady-state
    1 incidenza di eventi avversi emersi durante il trattamento (Treatment-Emergent Adverse Events, TEAE), eventi avversi gravi (Serious Adverse Events, SAE) e AE che determinano l’interruzione del farmaco in studio
    2 variazioni nel tempo rispetto al basale dei risultati delle analisi cliniche di laboratorio
    3 variazioni dei parametri vitali nel tempo rispetto al basale
    4 variazioni dei riscontri dell'esame obiettivo nel tempo rispetto al basale
    5 variazioni del peso corporeo e dell’altezza nel tempo rispetto al basale
    6 variazioni dei risultati dell'ECG nel tempo rispetto al basale
    7 variazioni dei parametri ecocardiografici dal basale al mese 12/all'interruzione precoce (Early Termination, ET)
    8 variazioni dello stadio di Tanner dal basale al mese 12/ET
    9 uso di farmaci concomitanti
    10 modello di farmacocinetica della popolazione che descriva la relazione tra peso ed età e farmacocinetica di migalastat in soggetti pediatrici
    11 Cmax: concentrazione plasmatica massima osservata
    12 Cmin: concentrazione plasmatica minima osservata
    13 tmax: tempo per raggiungere Cmax
    14 AUC0-t: area sotto la curva della concentrazione plasmatica nel tempo dal tempo 0 durante l'intervallo di somministrazione (ossia, 48 ore)
    15 t½: emivita di eliminazione terminale
    16 CLss/F: clearance orale apparente alla concentrazione di stato stazionario
    17 Vss/F: volume di distribuzione orale apparente alla concentrazione di stato stazionario
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Month 12
    2. baseline over time; up to 12 months
    3. baseline over time; up to 12 months
    4. baseline over time; up to 12 months
    5. baseline over time; up to 12 months
    6. baseline over time; up to 12 months
    7. baseline to Month 12/ET
    8. baseline to Month 12/ET
    9. baseline to Month 12/ET
    10. baseline to Month 12/ET
    11. Day 15-30, Months 6 and 12/ET
    12. Day 15-30, Months 6 and 12/ET
    13. Day 15-30, Months 6 and 12/ET
    14. Time Frame: Day 15-30, Months 6 and 12/ET
    15. Day 15-30, Months 6 and 12/ET
    16. popPK: Day 15-30, Months 6 and 12/ET
    17. popPK: Day 15-30, Months 6 and 12/ET
    1. mese 12
    2. baseline over time; fino a mese 12
    3. baseline over time; fino a mese 12
    4. baseline over time; fino a mese 12
    5. baseline over time; fino a mese 12
    6. baseline over time; fino a mese 12
    7. baseline fino a mese 12/ET
    8. baseline fino a mese 122/ET
    9. baseline fino a mese 12/ET
    10. baseline fino a mese 12/ET
    11. Giorno 15-30, Mese 6 e 12/ET
    12. Giorno 15-30, Mese 6 e 12/ET
    13. Giorno 15-30, Mese 6 e 12/ET
    14. Time Frame: Giorno 15-30, Mese 6 e 12/ET
    15. Giorno 15-30, Mese 6 e 12/ET
    16. popPK: Giorno 15-30, Mese 6 e 12/ET
    17. popPK: Giorno 15-30, Mese 6 e 12/ET
    E.5.2Secondary end point(s)
    1. change in plasma levels of lyso-Gb3
    2. change in eGFR
    3. change in urine protein and albumin levels
    4. change in LVMi and other echocardiogram parameters
    5. change in gastrointestinal signs and symptoms and pain, as measured by e-diary responses (Short FABPRO-GI and Pain Questionnaire)
    6. mean Patient Global Impression of Change (PGI-C) values
    7. change in FPHPQ scores
    8. change in PedsQL scores
    1. variazione dei livelli plasmatici di lyso-Gb3
    2. variazione eGFR
    3. variazione dei livelli di albuminuria e proteinuria
    4. variazione LVMi e altri parametri cardiaci basati su ecocardiogramma
    5. variazione in segni, sintomi e dolore gastrointestinali, misurata dalle risposte tramite e-diary (FABPRO-GI and Pain Questionnaire)
    6. Impressione globale di cambiamento da parte del/della paziente [Patient Global Impression of Change (PGI-C)])
    7. variazione nel punteggio FPHPQ
    8. variazione del punteggio PedsQL
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. baseline to Months 3, 6, and 12/ET
    2. baseline to Months 3, 6, and 12/ET
    3. baseline to Months 1, 3, 6, and 12/ET
    4. baseline to Month 12/ET
    5. baseline to Month 12/ET
    6. Months 3, 6 , 9 and 12/ET
    7. baseline to Month 12/ET
    8. baseline to Month 12/ET
    1. baseline fino a Mesi 3, 6, e 12/ET
    2. baseline fino a Mesi 3, 6, e 12/ET
    3. baseline fino a Mesi 1, 3, 6, e 12/ET
    4. baseline fino a Mese 12/ET
    5. baseline fino a Mese 12/ET
    6. Mesi 3, 6 , 9 e 12/ET
    7. baseline fino a Mese 12/ET
    8. baseline fino a Mese 12/ETT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Australia
    Germany
    Italy
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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 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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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 Decision2019-10-09
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-30
    P. End of Trial
    P.End of Trial Status
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