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    Summary
    EudraCT Number:2013-004622-29
    Sponsor's Protocol Code Number:101MS408
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 number2013-004622-29
    A.3Full title of the trial
    A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
    Studio multicentrico, randomizzato, in aperto per valutare l’impatto di natalizumab rispetto a fingolimod sul danno tissutale e il recupero del sistema nervoso centrale in soggetti affetti da sclerosi multipla attiva recidivante remittente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects
    Impatto di Natalizumab rispetto a Fingolimod sul danno tissutale e il recupero del sistema nervoso centrale in soggetti affetti da sclerosi multipla attiva recidivante remittente
    A.4.1Sponsor's protocol code number101MS408
    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.4.1Name of organisation providing supportBiogen Idec MA Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBiogen Idec Australia Pty Ltd
    B.4.2CountryAustralia
    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, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@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 Yes
    D.2.1.1.1Trade name Tysabri®
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    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 nameAN100226, BG00002
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    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 INNNATALIZUMAB
    D.3.9.1CAS number 189261-10-7
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 RoleComparator
    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 Gilenya
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameFingolimod
    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 INNfingolimod
    D.3.9.1CAS number 162359-56-0
    D.3.9.3Other descriptive nameFINGOLIMOD HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB30967
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple Sclerosis (MS)
    Sclerosi Multipla
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS)
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 assess the effect of natalizumab compared to fingolimod on the evolution of
    new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks.
    L’obiettivo primario dello studio consiste nel valutare l’effetto di natalizumab rispetto a fingolimod sull’evoluzione delle nuove lesioni captanti il gadolinio (Gd+) in T1 durante il trattamento ai buchi neri persistenti (persistent black holes, PBH) nell’arco di 52 settimane
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the effect of natalizumab compared to fingolimod on:
    • MRI measures of CNS tissue destruction as measured by the number of new T1-Gd+ lesions.
    • Various other MRI measures of disease activity.
    • No Evidence of Disease Activity (NEDA)
    • Relapse on treatment over 52 weeks.
    • The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).
    Gli obiettivi secondari di questo studio consistono nella valutazione dell’effetto di natalizumab rispetto a fingolimod sui seguenti aspetti:
    • Misurazioni mediante RMI in termini di danno tissutale a livello del SNC, in base al numero di nuove lesioni Gd+ in T1.
    • Varie altre misurazioni dell’attività di malattia mediante RMI.
    • Nessuna evidenza di attività della malattia
    • Recidiva durante il periodo di trattamento nell’arco di 52 settimane.
    • Variazioni nella velocità di elaborazione delle informazioni, in base al test delle modalità simboli e cifre (Symbol Digit Modalities Test, SDMT).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Diffusion Tensor Imaging (DTI) substudy, the structural changes in brain tissue within lesions and normal appearing white matter (NAWM) by measuring through voxel-wise analysis the extent and severity of fractional anisotrophy (FA)- and diffusivity-measured tissue damage of natalizumab- and fingolimodtreated subjects over 52 weeks compared to healthy volunteer cohort.
    Sottostudio di imaging con tensore di diffusione (Diffusion Tensor Imaging, DTI), modifiche strutturali del tessuto cerebrale nelle lesioni e nella sostanza bianca apparentemente normale (normal appearing white matter, NAWM) tramite misurazione con analisi dei voxel dell’estensione e della gravità della anisotropia frazionale (fractional anisotrophy, FA), e danno tissutale misurato tramite diffusività nei pazienti trattati con natalizumab e fingolimod nelle 52 settimane rispetto alla coorte di volontari sani.
    E.3Principal inclusion criteria
    Inclusion Criteria for MS Patients:
    - Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at study screening.
    - If the subject is on BRACE at study screening:
    • He/she must have been on therapy for at least 12 months, and
    • Experienced ≥1 relapse within the last 6 months prior to study screening with ≥1 new T1-Gd+ lesion or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening.
    - If the subject is DMT naïve at study screening, he/she must have experienced ≥2 relapses in the 12 months prior to study screening. In addition, they must have had ≥1 new T1-Gd+ lesion or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months prior to study screening.
    - Willing to take natalizumab or fingolimod as the only DMTs for the duration of the study.
    - Must have an EDSS score from 0 to 5.5 inclusive at study screening.

    Inclusion Criteria for Healthy Volunteers:
    - Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.
    diagnosi documentata di SMRR allo screening (McDonald 2010 Criteria [Polman 2011]). I soggetti sottoposti a BRACE al momento dello screening devono essere in terapia da almeno 12 mesi. I soggetti sottoposti a BRACE devono aver avuto ≥1 recidiva nei 6 mesi precedenti lo screening dello studio e devono aver presentato ≥1 nuova lesione Gd+ in T1 o ≥2 nuove lesioni in T2 in una scansione RMI cerebrale eseguita ≤6 mesi prima dello screening dello studio, in base a un confronto con scansione RMI in T2 eseguita fino a 18 mesi prima dello screening dello studio.
    I soggetti naïve alla terapia modificante la malattia (disease-modifying therapy, DMT) al momento dello screening dello studio devono aver avuto almeno 2 recidive nell’anno precedente allo screening dello studio. Inoltre, devono aver presentato ≥1 nuova lesione Gd+ in T1 o ≥2 nuove lesioni in T2 in una scansione RMI cerebrale eseguita ≤6 mesi prima dello screening dello studio, in base a un confronto con scansione RMI in T2 eseguita fino a 18 mesi prima dello screening dello studio. Disposti a prendere natalizumab o fingolimod come unici DMT per tutta la durata dello studio. Un punteggio EDSS compreso tra 0 e 5,5 inclusi, al momento dello screening.
    I volontari sani devono presentare un buono stato di salute, come dimostrato dall’esame obiettivo e dall’anamnesi medica e non devono avere una storia o evidenza di malattie, patologie o disturbi gravi.
    E.4Principal exclusion criteria
    Exclusion Criteria for MS Patients:
    - History of or positive test result at study screening for human immunodeficiency virus (HIV).
    - History or positive test result at study screening for hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/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 (definitions are based on the United States (US) Centers for Disease Control and Prevention [CDC]’s interpretation of the hepatitis B serology panel).
    - Prior treatment with natalizumab or fingolimod
    - Diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS]

    -Exclusion Criteria for Healthy Volunteers:
    - Claustrophobia sufficient to interfere with generating reliable MRI scans
    - History of other major illness including neurological disorders as determined by the Investigator
    - Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects), which would be a contraindication for MRI
    Esclusioni per malati di SM: Storia di HIV o test per il virus dell'immunodeficienza umana (HIV) positivo allo screening. Storia di Epatite C o risultato positivo allo screening per l’anticorpo del virus dell'epatite C (HCV) o infezione in corso da epatite B (definiti come [HBsAg] e / o [HBcAb] positivo per l'epatite B). I soggetti con immunità al virus dell'epatite B dovuta sia a vaccinazione attiva (definita come HBsAg negativo, [HBsAb] positivo e HBcAb negativo) o ad una precedente infezione naturale (definito come HBsAg negativo, immunoglobulina G HBsAb positivo, e HBcAb positivo) sono ammissibili a partecipare allo studio (definizioni si basano sull’interpretazione del pannello sierologico per l’ epatite B del United States (US) Centers for Disease Control and Prevention [CDC]). Precedente trattamento con Natalizumab o fingolimod. Diagnosi di sclerosi multipla progressiva primaria e/o sclerosi multipla progressiva secondaria.
    Eslusioni per volontari sani: Claustrofobia sufficiente per interferire con la generazione di scansioni RM affidabili - Storia di altre malattie importanti tra cui disturbi neurologici come determinato dallo sperimentatore - Presenza di un dispositivo di metallo che influenzi la risonanza magnetica (ad esempio, qualsiasi tipo di impianto elettronico, meccanico o magnetico, pacemaker cardiaco, clip da aneurisma , impiantato defibrillatore cardiaco) o potenziale corpo estraneo ferromagnetico (schegge di metallo, trucioli metallici, altri oggetti metallici), che sarebbe una controindicazione per la risonanza magnetica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the cumulative number of ≥6-month confirmed T1-hypointense lesions (i.e., PBH) arising from new on-treatment T1-Gd+ lesions.
    L’end point primario dello studio è il numero cumulativo di lesioni ipointense in T1 confermate da ≥6 mesi (ovvero PBH) risultanti da nuove lesioni Gd+ in T1 durante il trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12, 16, 20, 24, 52
    settimane 4, 8, 12, 16, 20, 24, 52
    E.5.2Secondary end point(s)
    The secondary endpoints of this study are the follwoing:
    • MRI endpoints:
    o Cumulative number of new T1-Gd+ lesions .
    o Change in total T1-hypointense and total T2-hyperintense lesion volumes.
    o Cumulative number of new or enlarging T2 lesions.
    • Proportion of subjects with NEDA according to the following definition:
    o No relapses.
    o No 12-week confirmed disability progression based on EDSS.*
    o No new T1-Gd+ lesions on brain MRI.
    o No new or enlarging T2-hyperintense lesions.
    • Time to first relapse, cumulative risk of relapses and time to complete recovery from first relapse. **
    • Change in information processing speed as measured by the SDMT from baseline to Week 24 and Week 52.

    * Increase of 1.0 or more on the EDSS from a baseline score of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0 that was sustained for 12 weeks (progression could not be confirmed during a relapse).
    ** 12-week confirmed complete Expanded Disability Status Scale (EDSS) recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 week
    • Endpoint mediante RMI:
    o Numero cumulativo di nuove lesioni Gd+ in T1
    o Variazione del volume delle lesioni ipointense in T1 totali e del volume delle lesioni iperintense in T2 totali
    o Numero cumulativo di lesioni nuove o ingrandite in T2.
    • Percentuale di soggetti con assenza di malattia attiva evidente (No Evidence of Disease Activity - NEDA) in base alla seguente definizione:
    o Nessuna recidiva.
    o Nessuna progressione dell’invalidità confermata a 12 settimane sulla base del punteggio EDSS.*
    o Nessuna nuova lesione Gd+ in T1 evidenziata dalla RMI cerebrale
    o Nessuna lesione iperintensa nuova o ingranditasi in T2.
    • Tempo alla prima recidiva, rischio cumulativo di recidiva e tempo per la guarigione completa dalla prima recidiva. **
    • Variazione nella velocità di elaborazione delle informazioni misurata tramite SDMT dal basale alla Settimana 24 e Settimana 52.
    * Aumento di almeno 1,0 punti nella scala EDSS dal punteggio basale di 1,0 o superiore, oppure aumento di almeno 1,5 punti dal punteggio basale di 0 e mantenuto per 12 settimane (non è stata confermata la progressione durante una recidiva).
    ** La guarigione completa confermata di 12 settimane in base alla scala EDSS dal momento della prima recidiva durante il trattamento è definita come un punteggio EDSS uguale o inferiore all’ultimo punteggio EDSS prima della recidiva e mantenuto per almeno 12 settimane.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, 12, 16, 20, 24, 52
    settimane 4, 8, 12, 16, 20, 24, 52
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Australia
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    United States
    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
    LVLS
    LPLV
    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 months7
    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 months7
    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: 540
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 327
    F.4.2.2In the whole clinical trial 540
    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 Decision2014-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-19
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