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    Summary
    EudraCT Number:2020-003664-29
    Sponsor's Protocol Code Number:EP0156
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003664-29
    A.3Full title of the trial
    Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
    Studio multicentrico in aperto, a braccio singolo per valutare la sicurezza e la tollerabilità a lungo termine di brivaracetam usato come trattamento aggiuntivo in soggetti pediatrici partecipanti allo studio affetti da epilessia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the safety and tolerability of brivaracetam in pediatric study participants with seizures.
    Studio per valutare la sicurezza e la tollerabilità di brivaracetam in soggetti pediatrici partecipanti allo studio con convulsioni.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberEP0156
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number000000000000000
    B.5.5Fax number00000000000000
    B.5.6E-mailclinicaltrials@ucb.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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrivaracetam
    D.3.2Product code [ucb 34714]
    D.3.4Pharmaceutical form Oral solution
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrivaracetam
    D.3.2Product code [ucb 34714]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    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 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: 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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrivaracetam
    D.3.2Product code [ucb 34714]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 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 Briviact
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrivaracetam
    D.3.2Product code [ucb 34714]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeBRV
    D.3.9.4EV Substance CodeSUB25397
    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 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
    Epilepsy
    Epilessia
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilessia
    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 10015039
    E.1.2Term Epilepsy congenital
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of BRV.
    Valutare la sicurezza e tollerabilità a lungo termine di BRV.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicabili.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for long-term follow-up (LTFU) study participants only:
    - Study participants with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected.
    Inclusion criteria for directly enrolled (DE) study participants only:
    - Study participant is >or= 4 years to < 16 years of age;
    - Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years;
    - Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED);
    - Study participant had at least 1 POS during the 4-week Screening Period;
    - Study participant is taking at least 1 AED. Vagal nerve stimulator will be counted as a concomitant AED.
    Criteri di inclusione solo per i partecipanti allo studio di follow up a lungo termine:
    - Partecipanti allo studio con diagnosi di epilessia confermata, che hanno partecipato agli studi core N01266 [] e/o N01349 [] e per i quali ci si aspetta un ragionevole beneficio dal trattamento a lungo termine con brivaracetam (BRV);
    Criteri di inclusione per i soggetti direttamente arruolati nello studio:
    - il partecipante allo studio ha un’età compresa tra >o=4 anni e <16 anni;
    - il partecipante allo studio dispone di una lettura dell’elettroencefalogramma (EEG) compatibile con la diagnosi di epilessia focale negli ultimi 10 anni;
    - il partecipante allo studio presenta POS incontrollate dopo un adeguato ciclo di trattamento (secondo il parere dello sperimentatore) con almeno 1 AED;
    - il partecipante allo studio ha manifestato almeno 1 POS durante il periodo di screening di 4 settimane;
    - il partecipante allo studio sta assumendo almeno 1 AED. La stimolazione del nervo vago sarà considerata come AED concomitante.
    E.4Principal exclusion criteria
    Exclusion criteria for all study participants:
    - Study participant has, in the Investigator's opinion, severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant;
    - Study participant has any medical condition including chronic liver disease, which in the Investigator's opinion, warrants exclusion;
    - Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam
    (BRV). The use of antiepileptic drugs (AEDs) marketed for adults but not approved for pediatric use is not considered to be "investigational" for the purposes of this study;
    - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical
    monitor, contraindicates participation in the study.
    Exclusion criteria for long-term follow-up (LTFU) study participants only:
    - Study participant had poor compliance with the visit schedule or medication intake in the BRV core study;
    - Study participant >or= 6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted
    attempt), or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS).
    Exclusion criteria for directly enrolled (DE) study participants only:
    - Study participant has a history of primary generalized epilepsy;
    - Study participant has a history of status epilepticus in the 30 days immediately prior to the Screening Visit (ScrV) or during the Screening
    Period;
    - Study participant has history or presence of known psychogenic nonepileptic seizures;
    - Study participant has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary;
    - Study participant has any clinically significant acute or chronic illness as determined during the physical examination or from other information
    available to the Investigator (eg, bone marrow suppression, chronic hepatic disease, severe renal impairment, psychiatric disorder as per
    Investigator assessment);
    - Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, according to the judgment of the Investigator;
    - Study participant has a clinically significant ECG abnormality according to the Investigator;
    - Study participant had major surgery within 6 months prior to the ScrV.
    Criteri di esclusione per tutti i partecipanti allo studio:
    - a giudizio dello sperimentatore, il partecipante allo studio soffre di gravi disturbi medici, neurologici o psichiatrici o presenta valori di laboratorio che potrebbero avere un impatto sulla sua sicurezza;
    - il partecipante allo studio presenta una qualsiasi condizione medica, compresa una malattia epatica cronica, che, secondo l’opinione dello sperimentatore, ne giustifica l’esclusione;
    - il partecipante allo studio sta attualmente partecipando a un altro studio di un farmaco (o un dispositivo medico) sperimentale diverso da BRV. L’uso di AED commercializzati per gli adulti, ma non approvati per uso pediatrico, non è considerato “sperimentale” ai fini di questo studio;
    - sensibilità a uno qualunque dei trattamenti dello studio o ai relativi componenti, o a un farmaco oppure altra allergia che, secondo l’opinione dello sperimentatore o del responsabile del monitoraggio medico, può rappresentare una controindicazione alla partecipazione allo studio.
    Criteri di esclusione solo per i partecipanti allo studio di follow up a lungo termine:
    - il partecipante allo studio ha manifestato ipersensibilità a BRV oppure a eccipienti o composti chimicamente correlati a BRV nel corso dello studio principale di BRV;
    - il partecipante allo studio di età >o=6 presenta nell’arco della sua vita un tenativo di suicidio (incluso un tentativo attivo, un tentativo interrotto o un tentativo fallito), oppure ha manifestato un’ideazione suicida negli ultimi 6 mesi come indicato da una risposta positiva (“Sì”) alla Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS).
    Criteri di esclusione solo per i partecipanti allo studio con arruolamento diretto:
    - il partecipante allo studio presenta un’anamnesi di epilessia primaria generalizzata;
    - il partecipante allo studio presenta un’anamnesi di stato epilettico nei 30 giorni immediatamente precedenti la visita di screening o durante il periodo di screening;
    - il partecipante allo studio presenta un’anamnesi o presenza di crisi convulsive psicogene non epilettiche note;
    - Il partecipante allo studio ha manifestato esclusivamente crisi convulsive febbrili. L’insorgenza di crisi convulsive febbrili oltre ad altre crisi convulsive non provocate non determina l’esclusione;
    - il partecipante allo studio presenta una qualunque malattia acuta o cronica clinicamente significativa, in base a quanto determinato durante l’esame obiettivo o ad altre informazioni in possesso dello sperimentatore (per es. soppressione del midollo osseo, epatopatia cronica, grave insufficienza renale, disturbi psichiatrici, secondo la valutazione dello sperimentatore);
    - il partecipante allo studio presenta anomalie di laboratorio clinicamente significative che possono aumentare il rischio associato alla partecipazione allo studio o interferire con l’interpretazione dei risultati dello studio, secondo il giudizio dello sperimentatore;
    - il partecipante allo studio presenta un’anomalia ECG clinicamente significativa secondo lo sperimentatore;
    - il partecipante allo studio ha subito un intervento di chirurgia maggiore nei 6 mesi precedenti la visita di screening.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of treatment-emergent adverse events (TEAEs) during the study;
    2. Incidence of treatment-emergent serious adverse events (SAEs) during the study;
    3. Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study.
    1. Incidenza di eventi avversi emergenti dal trattamento (TEAE) durante lo studio;
    2. Incidenza di eventi avversi seri (SAE) emergenti dal trattamento durante lo studio;
    3. Incidenza di TEAE che portano all’interruzione del farmaco dello studio durante lo studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3. From Entry Visit (Day 1) until Safety Visits (up to 5 years).
    1-3. Dalla visita di ingresso (Giorno 1) fino alle visite di sicurezza (fino a 5 anni).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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-label.
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Japan
    Mexico
    United States
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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
    LPLV.
    Ultima visita dell'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days12
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable.
    Non applicabile.
    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 Decision2021-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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