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    Summary
    EudraCT Number:2014-003021-18
    Sponsor's Protocol Code Number:109MS308
    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:2015-02-18
    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 number2014-003021-18
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Delaying Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo sull’efficacia e sulla sicurezza di BG00012 nel ritardare la progressione della disabilità in soggetti con sclerosi multipla secondaria progressiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study of BG00012 in slowing the progression of disability in patients with Secondary Progressive Multiple Sclerosis.
    Uno studio sulla sicurezza e l'efficacia di BG00012 nel rallentare la progressione della disabilità nei pazienti con sclerosi multipla secondaria progressiva.
    A.4.1Sponsor's protocol code number109MS308
    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 SponsorBiogen Idec Research Limited
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/a
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailcta.submissions@biogenidec.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 nameBG00012
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDimethyl Fumarate
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDimethyl Fumarate
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    Secondary Progressive Multiple Sclerosis
    Sclerosi Multipla secondariamente progressiva
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to investigate whether treatment with BG00012 compared with placebo slows the accumulation of disability not related to relapses in subjects with SPMS.
    L’obiettivo primario dello studio è quello di determinare se il trattamento con BG00012 rispetto al placebo rallenta l’accumulo di invalidità non correlata alle recidive nei soggetti con SMSP.
    E.2.2Secondary objectives of the trial
    To assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function
    Valutare l’effetto di BG00012 rispetto al placebo in esiti riportati dai pazienti, atrofia cerebrale e funzione cognitiva
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics sub-study.
    Subjects who consent to participate will provide a blood sample that will be used for exploratory pharmacogenomic analysis. The deoxyribonucleic acid (DNA) will be used to explore identification of specific genetic polymorphisms associated with MS and study treatment response.

    Sample Banking for Future Scientific Research
    Subjects who consent to participate will give permission for MRI images and leftover blood samples to be used for future scientific research to characterize potential biomarkers.

    Lymphocyte subset analysis and processing PBMC for future exploratory analysis.
    Subjects who consent to participate will provide blood samples that will be used for lymphocyte subsets, Ig levels, and future PBMC analysis for further lymphophenotyping and functional analysis, if indicated by flow cytometry test results.
    Sottostudio di Farmacogenetica
    I soggetti che acconsentono di partecipare forniranno un campione di sangue che verrà tilizzato per l'analisi farmacogenomica esplorativa. L’acido desossiribonucleico (DNA) sarà usato per esplorare identificazione di
    polimorfismi genetici specifici associati con SM e la risposta al trattamento dello studio.

    Campione Banking per il futuro della ricerca scientifica
    I soggetti che acconsentono di partecipare daranno il permesso per utilizzare immagini MRI e campioni di sangue rimasto per futura ricerca scientifica per caratterizzare potenziali biomarcatori.

    Analisi del sottoinsieme dei linfociti ed elaborazione delle cellule mononucleari di sangue periferico (PBMC) per analisi esplorative future.
    I soggetti che acconsentono di partecipare forniranno campioni di sangue che verranno
    utilizzati per sottopopolazioni linfocitarie, livelli di Ig, e future analisi di PBMC per
    ulteriore fenotipizzazione linfatica e analisi funzionale, se indicati dai risultati del test della citometria a flusso
    E.3Principal inclusion criteria
    - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
    - Age 18 to 58 years, inclusive, at the time of informed consent.
    - Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as relapsing remitting disease followed by progression of disability independent of or not explained by relapses.
    - Have EDSS score of 3.0 to 6.5, inclusive.
    - Have an MS Severity Score of 4 or higher.
    - Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization as defined in the Study Reference Guide.
    - Subjects must be able to successfully complete the assessments associated with each component of the primary endpoint (EDSS, T25FW, 9HPT) at Screening, where successful completion of the T25FW and 9HPT is defined as follows:
    •At Screening, T25FW completed in ≤30 seconds
    •At Screening, 9HPT completed with each hand in ≤300 seconds.
    - All women of childbearing potential (including female subjects who are post menopausal for less than 1 year) and all men must practice effective contraception throughout the study and be willing and able to continue contraception after their last dose of study treatment (women for 30 days; men for 90 days).
    - Capacità di comprendere lo scopo e rischi dello studio e fornireun consenso informato firmato e datato e l'autorizzazione ad utilizzare le informazioni sanitarie protette in conformità con le normative sulla privacy della persona nazionali e locali
    - Età compresa fra 18 e 58 anni inclusi, al momento del consenso informato
    - Esordio di SMSP almeno 1-2 anni prima della randomizzazione. SPMS è definita come malattia recidivante remittente seguito da progressione di disabilità indipendente da o non spiegata da recidive.
    - Avere un punteggio EDSS compreso fra 3,0 e 6,5 inclusi.
    - Avere un punteggio di gravità della SM di 4 o superiore.
    - Avere prova documentata e confermata di progressione della malattia indipendentemente dalle recidive cliniche oltre 1 anno prima dell’arruolamento come definito dalla Guida di riferimento dello studio
    - I soggetti devono essere in grado di completare con successo le valutazioni
    associato a ciascun componente dell’endpoint primario (EDSS, T25FW,
    9HPT) allo screening, laddove completamento con successo di T25FW e
    9HPT è definito come segue:
     Allo screening, T25FW completato in ≤30 secondi
     Allo screening, 9HPT completato con ciascuna mano in ≤300 secondi
    - Tutte le donne in età fertile (inclusi i soggetti femminili che sono in post-menopausa da meno di 1 anno) e tutti gli uomini devono praticare la contraccezione efficace durante lo studio ed essere disposti e in grado di continuare la contraccezione dopo la loro ultima dose del trattamento in studio (donne per 30 giorni; uomini per 90 giorni).
    E.4Principal exclusion criteria
    - Have a diagnosis of RRMS or primary progressive MS as defined by the revised McDonald criteria
    - Had a recent clinical relapse (within 3 months) prior to randomization
    - Subjects for whom MRI is contraindicated (i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to Gd, or have claustrophobia that cannot be medically managed) or for whom the MRI cannot be performed
    - Uncontrolled intercurrent illness including, but not limited to- ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements
    - History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
    - History of human immunodeficiency virus
    - History of or positive test result at Screening for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study
    - History of severe allergic or anaphylactic reactions or known drug hypersensitivity to fumaric acid or fumaric acid esters
    - Any of the following abnormal blood tests at Screening that are confirmed on repeat testing 2 weeks later:
    • ALT/serum glutamate-pyruvate transaminase (SGPT), or AST/serum glutamic-oxaloacetic transaminase (SGOT), or gamma-glutamyl-transferase (GGT) ≥2 times the ULN
    • WBC <3500/mm3
    • eosinophils >0.7 x 10³/μL or >0.7 GI/L
    • absolute lymphocyte count LLN.
    - Any of the following abnormal urine tests at Screening confirmed by a second urinalysis 2 weeks later:
    • proteinuria (1+ or greater)
    • hematuria, without known etiology
    • glycosuria, without known etiology
    - Any previous treatment with BG00012 or any fumaric acid ester containing product
    - Prior treatment with any of the following:
    • cladribine
    • alemtuzumab
    • total lymphoid irradiation
    • any therapeutic monoclonal antibody, with the exception of natalizumab (Tysabri®), daclizumab, and rituximab
    - Treatment with any of the following medications or procedures within the 6 months prior to randomization:
    • mitoxantrone
    • cyclophosphamide
    • cyclosporine
    • azathioprine
    • teriflunomide
    • methotrexate
    • natalizumab
    • daclizumab
    • rituximab
    • fingolimod
    • mycophenolate mofetil
    • T-cell or T-cell receptor vaccination
    • laquinimod
    • cytapheresis
    - Treatment with any of the following within the 3 months prior to randomization:
    • intravenous (IV) steroids or oral corticosteroids
    • IV IG
    • plasmapheresis
    - Treatment with any of the following within the 4 weeks prior to randomization:
    • subcutaneous or oral glatiramer acetate
    • interferon-β
    - Treatment with fampridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study.
    - Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization
    - Female subjects who are pregnant or currently breastfeeding, or planning to become pregnant while in the study.
    - History of drug or alcohol abuse, in the opinion of the Investigator, within 2 years prior to randomization.
    - Current enrollment in any interventional clinical study in which an investigational drug or approved therapy for investigational use is administered within 6 months (or 5 half-lives of the agent, whichever is longer) prior to the Baseline Visit.
    - Unwillingness or inability to comply with study requirements, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the study protocol.
    - Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment in this study.
    - Previous participation in the study
    - Avere una diagnosi di sclerosi multipla recidivante-remittente (RRMS) o sclerosi multipla progressiva primaria, come definito dai criteri di McDonald rivisti
    - Aver avuto una ricaduta clinica recente (entro 3 mesi) prima della randomizzazione
    - I soggetti per i quali la risonanza magnetica è controindicata (cioè, hanno pacemaker o altri dispositivi metallici impiantati controindicati, sono allergici al gadolinio, o
    hanno claustrofobia che non può essere gestita in maniera medica) o per i quali
    la MRI non può essere eseguita
    - Malattie intercorrenti incontrollate tra cui, ma non solo in infezione in corso
    o attiva; insufficienza cardiaca congestizia sintomatica; angina pectoris instabile; aritmia cardiaca; disfunzione del fegato, rene, o del midollo osseo grave o acuta; diabete non controllato; malattia psichiatrica grave o acuta che limiterebbe la conformità con i requisiti di studio
    - Storia di malignità (soggetti con carcinoma a cellule basali che è stato
    completamente asportato prima dell'ingresso nello studio rimangono ammissibili)
    - Storia di HIV
    - Storia di o test positivo allo Screening agli anticorpi del virus dell’ Epatite C o Epatite B (definita come positiva all’ dell'antigene di
    superficie dell'epatite B [HBsAg] o all’anticorpo core dell’epatite B [HBcAb]. I soggetti con immunità ai epatite B sia da vaccinazione attiva (definita come negatività all’HBsAg, anticorpo di superficie positivo all’epatite B [HBsAb] e HBcAb negativo) o dal precedente infezione naturale (definito come HBsAg negativo, HBsAb immunoglobulina G positivo, e HBcAb positivo) sono ammessi a partecipare allo studio
    - Storia di reazioni allergiche o anafilattiche gravi o di ipersensibilità nota all'acido fumarico o agli esteri dell'acido fumarico
    - Uno dei seguenti esami del sangue anomali allo screening che sono
    confermata ripetendo il test dopo 2 settimane:
    o ALT/ transaminasi sierica glutamico piruvica (SGPT), or AST/ Transaminasi glutammico-ossalacetica (SGOT), or Gamma glutamil transferasi (GGT) ≥2 volte il limite superiore della norma
    o (leucociti) WBC <3500/mm3
    o eosinofili >0.7 x 10³/μL or >0.7 GI/L
    o conta assoluta dei linfociti < Limite inferiore della norma
    - Uno dei seguenti esami delle urine anormali allo screening confermata da una
    seconda analisi delle urine dopo 2 settimane:
    o proteinuria (1+ o superiore)
    o ematuria senza eziologia nota
    o glicosuria, senza eziologia nota
    o Qualsiasi precedente trattamento con BG00012 o estere di acido fumarico prodotto contenente
    - Precedente trattamento con uno dei seguenti:
    o Cladribina
    o Alemtuzumab
    o irradiazione linfoide totale
    o qualsiasi anticorpo monoclonale terapeutico, con l'eccezione di
    natalizumab (Tysabri), daclizumab, e rituximab
    - Il trattamento con uno qualsiasi dei seguenti farmaci o procedure entro
    6 mesi prima della randomizzazione:
    o Mitoxantrone
    o Ciclofosfamide
    o Ciclosporina
    o Azatioprina
    o Teriflunomide
    o Metotrexato
    o Natalizumab
    o Daclizumab
    o Rituximab
    o Fingolimod
    o Mofetil Micofenolato
    o Vaccini a cellule T o a recettore delle cellule T
    o Laquinimod
    o citoaferesi

    - Il trattamento con uno dei seguenti entro i 3 mesi precedenti
    randomizzazione:
    o steroidi o corticosteroidi orali per via endovenosa (IV)
    o Immunoglobuline endovena
    o Plasmaferesi
    - Il trattamento con uno qualsiasi dei seguenti entro 4 settimane prima
    randomizzazione:
    • glatiramer acetato per via sottocutanea o orale
    • interferone-β
    - Il trattamento con fampridina entro 30 giorni prima della randomizzazione,
    a meno che una dose stabile sia stata mantenuta per almeno 30 giorni prima della
    randomizzazione e verrà continuata per il corso di questo studio.
    - Il trattamento con un altro farmaco sperimentale o terapia approvata per
    uso sperimentale nei 6 mesi precedenti la randomizzazione
    - Soggetti di sesso femminile in stato di gravidanza o attialmente in allattamento, o che
    stiano pianificando una gravidanza nel periodo in cui dovrebbero essere nello studio.
    - Storia di abuso di droga o alcol, a giudizio dello sperimentatore, nei due anni 2 precedenti la randomizzazione.
    - Attuale arruolamento in qualsiasi studio clinico interventistico in cui un
    farmaco sperimentale o terapia approvata per l'uso in fase di sperimentazione sia somministrato entro 6 mesi (o 5 emivite dell'agente, a seconda di quale tempistica sia
    più lunga) prima della visita basale.
    - Riluttanza o l'incapacità di rispettare i requisiti di studio, tra cui la presenza di qualsiasi condizione (fisica, mentale o sociale) che è probabile che influenzi la capacità del soggetto di rispettare il protocollo di studio.
    - Altri motivi non specificati che, a giudizio dello sperimentatore o
    Biogen Idec, rendono il soggetto inadatto per l'arruolamento in questo studio.
    - Precedente partecipazione allo studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is time to disability progression independent of relapse, where progressors are defined as subjects who meet at least 1 of the following criteria confirmed at a second visit ≥6 months later and at Week 108 (or at the last available study visit for subjects who withdraw from the study early):
    - EDSS: increase from Baseline of ≥1 point if Baseline EDSS ≤5.5, or ≥0.5 point if Baseline EDSS ≥6.0
    - T25FW: ≥20% increase from Baseline in the time taken for the 25-foot walk
    - 9HPT: ≥20% increase from Baseline in the time taken for the 9HPT (increase must be confirmed in the same hand)
    Tempo alla progressione dell'invalidità indipendentemente dalla recidiva, dove sono definiti progressori i soggetti che rispondono ad almeno 1 dei seguenti criteri confermati a una seconda visita ≥6 mesi più tardi e alla Settimana 108 (o all’ultima visita di studio disponibile per i soggetti che si sono ritirati prematuramente dallo studio):
    • EDSS: aumento dal basale di ≥1 punto se la Scala di invalidità espansa (EDSS) ≤5,5, oppure ≥0,5 punti se EDSS al basale ≥6,0
    • Test di deambulazione di 25 piedi (Timed 25 foot walk, T25FW): aumento del ≥20% dal basale nel tempo impiegato per percorrere 25 piedi (pari a 7,62 metri)
    • Test dei 9 pioli (9-hole peg test, 9HPT): aumento del ≥20% dal basale nel tempo impiegato per il test dei 9 pioli (l’aumento deve essere confermato con la stessa mano)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks
    Ogni 12 settimane
    E.5.2Secondary end point(s)
    - Change from Baseline to 2 years on the 12 Item Multiple Sclerosis Walking Scale (MSWS 12)
    - Change from Baseline to Week 108 in ABILHAND Questionnaire score
    - Percentage change from Baseline to Week 108 in whole brain volume
    - Change from Baseline to Week 108 in cognitive function as measured by the SDMT
    • Cambiamento dal basale a 2 anni sulla Scala di deambulazione della sclerosi multipla (12-Item Multiple Sclerosis Walking Scale, MSWS-12)
    • Cambiamento dal basale alla Settimana 108 nel punteggio del questionario ABILHAND
    • Cambiamento in percentuale dal basale alla Settimana 108 in tutto il volume cerebrale
    • Cambiamento dal basale alla Settimana 108 nella funzione cognitiva, secondo la valutazione del Test di modalità dei simboli e delle cifre (Symbol Digit Modalities Test, SDMT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 12 weeks, except for the change in the whole brain volume, which will be evaludated at Week 108
    Ogni 12 settimane, tranne per il cambiamento di tutto il volume cerebrale, che
    sarà valutato alla settimana 108
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Switzerland
    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 years4
    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 years4
    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 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: 1170
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 780
    F.4.2.2In the whole clinical trial 1170
    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)
    All subjects who complete this study according to the protocol and who are eligible may choose to be enrolled into an open label extension study in which all subjects will receive BG00012.
    Tutti i soggetti che hanno completato lo studio secondo il protocollo e che siano eleggibili potranno scegliere di essere arruolati in uno studio di estensione in aperto in cui tutti i soggetti riceveranno BG00012
    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 Decision2015-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-21
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