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    Summary
    EudraCT Number:2012-000368-90
    Sponsor's Protocol Code Number:218MS205
    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:2012-09-12
    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 number2012-000368-90
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)
    Studio esplorativo, multicentrico, randomizzato, in doppio cieco, controllato verso placebo per valutare l'effetto del trattamento con fampridina a rilascio prolungato (BIIB041) 10mg, due volte al giorno, sulla capacità di deambulazione e l'equilibrio in soggetti con sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prolonged-Release Fampridine Effect on Walking Ability and Balance in Multiple Sclerosis
    Effetto della Fampridina a rilascio prolungato sulla capacita' di camminare e sull’equilibrio nella sclerosi multipla
    A.4.1Sponsor's protocol code number218MS205
    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 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 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 pointnd
    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.5.4Telephone numbernd
    B.5.5Fax numbernd
    B.5.6E-mailmobile@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 Fampyra
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Prolonged-release 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 INNFAMPRIDINE
    D.3.9.1CAS number 504-24-5
    D.3.9.2Current sponsor codeBIIB041
    D.3.9.4EV Substance CodeSUB07505MIG
    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 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 placeboCoated tablet
    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
    Multiple Sclerosis
    Sclerosi Multipla
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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 objectives of this study in MS subjects treated with prolongedrelease fampridine 10 mg twice daily compared with subjects treated with placebo are: To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters to explore endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static balance, subjective impression of well-being, subjects' global impression of change in walking To evaluate the safety and tolerability of prolonged-release fampridine.
    Gli obiettivi del presente studio condotto su soggetti affetti da SM trattati con fampridina 10 mg a rilascio prolungato due volte al giorno rispetto ai soggetti trattati con placebo sono: -Valutare gli effetti della fampridina a rilascio prolungato per un periodo di 24 settimane relativamente ai seguenti parametri, al fine di esaminare gli endpoint per lo studio di Fase 3:autovalutazione della disabilità deambulatoria, equilibrio statico e dinamico,impressione soggettiva di benessere, impressione globale del soggetto sulla variazione nella deambulazione. Valutare la sicurezza e la tollerabilita' della fampridina a rilascio prolungato.
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:2
    Date:2012/01/26
    Title:Pharmacogenomic assessment
    Objectives:The substudy is optional. The pharmacogenomic analysis will explore identification of specific genetic polymorphisms associated with study treatment response. DNA may be used for genome-wide or candidate gene single nucleotide polymorphism (SNP) analyses. Allelic variants at SNP loci will be tested for association with safety and efficacy measurements from the study.

    FARMACOGENOMICA:
    Vers:2
    Data:2012/01/26
    Titolo:Valutazione di farmacogenomica
    Obiettivi:Il sottostudio e' opzionale. L'analisi farmacogenomica esplorera' l'identificazione di specifici polimorfismi associati alla risposta al trattamento in studio.Il DNA puo' essere usato per l'analisi dell'intero genoma o del singolo polimorfismo(SNP)del gene candidato. Varianti alleliche in loci di SNP saranno testati per l'associazione con le misure di sicurezza e di efficacia dello studio.

    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit (SV) or at the timepoint specified in the individual eligibility criterion listed: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Male or female subjects must be 18 to 70 years old, inclusive, at the time of informed consent. 3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria ([McDonald et al, 2001; Polman et al, 2005] as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3-month duration. 4. EDSS 4 to 7 5. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. 6. Subjects must be able to understand and comply with the requirements of the protocol.
    Per risultare idonei alla partecipazione allo studio, i candidati devono soddisfare i seguenti criteri di inclusione in occasione della visita di screening (SV) o al momento specificato nel singolo criterio di inclusione elencato: 1. Capacità di comprendere lo scopo e i rischi dello studio, consegna di un consenso informato firmato e datato e autorizzazione all’utilizzo di informazioni sanitarie protette, in conformità alle normative nazionali e locali vigenti in materia di riservatezza dei dati soggettivi. 2.Soggetti di sesso maschile o femminile di età compresa tra 18 e 70 anni, compresi, al momento del consenso informato. 3. Diagnosi di SM primaria progressiva, secondaria progressiva, progressiva-remittente o recidivante-remittente secondo i criteri revisionati del Comitato McDonald ([McDonald et al, 2001; Polman et al, 2005]) definiti da Lublin e Reingold [Lublin e Reingold, 1996] accertata da almeno 3 mesi. 4. Punteggio EDSS da 4 a 7. 5. Le donne in età fertile devono adottare metodi contraccettivi efficaci durante lo studio ed essere disposte a continuare l’uso di contraccettivi per 30 giorni dopo l’assunzione dell’ultima dose del trattamento in studio. 6. I soggetti devono essere in grado di comprendere e osservare i requisiti del protocollo.
    E.4Principal exclusion criteria
    1.Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.2.Any history of seizure,epilepsy,or other convulsive disorder,with the exception of febrile seizures in childhood.3.An estimated CrCl of <80mL/minute.4.Known history of HIV,hepatitis C or B.5.History of malignant disease including solid tumors and hematologic malignancies within the 5 years prior to the Screening Visit (SV),or at any time during the screening period.6.Onset of MS exacerbation within the 60 days prior to the SV,or at any time during the screening period.7.History of any major surgical intervention within the 30 days prior to the SV, or at any time during the screening period.8.Any non-MS-related condition or factor that is likely to interfere with walking ability including,but not limited to,previous major surgery of the foot,leg,or hip;any significant trauma;or known peripheral neuropathy of the lower limb.9.Presence of pulmonary disease including,but not limited to, COPD that could impede the subject's daily activities.10.Presence of any psychiatric disorder,including clinical depression,that is likely to interfere with the subject's participation in the study.11. Uncontrolled hypertension at the SV,any time during the screening period,or Day 1.12.History of any clinically significant endocrinologic,hematologic,immunologic,metabolic,urologic,neurologic,dermatologic, or other major disease.13.Clinically significant abnormal laboratory values.14.A Body Mass Index ≥40.15.Use of off-label MS treatment including rituximab,alemtuzumab, daclizumab, or antibody(except natalizumab)within the 3 months prior to the SV,or any time during the screening period,or scheduled use during study participation.16.Use of mitoxantrone or cyclophosphamide within the 3 months prior to the SV,or any time during the screening period,or scheduled use during study participation.17.Initiation of natalizumab treatment or any change in the subject's dose or regimen of natalizumab,within the 3 months prior to the SV,or at any time during the screening period.18.Initiation of treatment with,or any change in the subject's dose or regimen of,interferon β-1b,β-1a,fingolimod, r glatiramer acetate within the 30 days prior to the SV,or at any time during the screening period.19.Pulsed steroid treatment within the 60 days prior to the SV,or at any time during the screening period.20.Any change in the subject's medication dose or regimen for the treatment of fatigue or depression within the 30 days prior to the SV,or at any time during the screening period.21.Any change in prophylactic treatment for pain with antidepressants or anticonvulsants prescribed for this purpose within 30 days prior to the SV,or at any time during the screening period.22.Any change in the subject's dose or regimen of antispastic agents within the 7 days prior to the SV,or at any time during the screening period.23. Treatment with an investigational drug or approved therapy for investigational use within the 30 days prior to the SV,or at any time during the screening period.24.Treatment with 4-AP or 3,4-diaminopyridine in any formulation within the 30 days prior to the SV,or at any time during the screening period.25.History of drug or alcohol abuse within the 2 years prior to the SV,or at any time during the screening period.26.Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.27.Female subjects who are currently breastfeeding.28.Inability to comply with study study requirements.29.Current enrollment in any other drug, biological, device, or clinical study.
    1.Allergia nota a sostanze contenenti piridina o a qualsiasi eccipiente contenuto nella compressa di fampridina a rilascio prolungato.2.Anamnesi di convulsioni,epilessia o altri disturbi convulsivi,ad eccezione delle convulsioni febbrili nell’infanzia. 3.CrCl stimata &lt;50 ml/minuto.4.Anamnesi nota di HIV,epatite C o B.5.Anamnesi di neoplasia maligna comprendente tumori solidi e neoplasie ematologiche maligne nell’arco dei 5 anni prima della SV o in qualsiasi momento del periodo di screening.6.Insorgenza di esacerbazione della SM entro i 60 giorni che precedono la SV o in qualsiasi momento del periodo di screening.7.Anamnesi di intervento chirurgico maggiore entro i 30 giorni prima della SV o in qualsiasi momento del periodo di screening.8.Condizione o fattore non associati alla SM in grado di interferire con la capacità di deambulazione,compresi,ma non solo,precedenti interventi chirurgici condotti su piede,gamba o anca,qualsiasi trauma significativo o neuropatia periferica nota dell’arto inferiore.9.Presenza di malattia polmonare compresa,ma non solo,la BPCO,potenzialmente in grado di ostacolare nello svolgimento delle attività quotidiane.10.Presenza di disturbo psichiatrico,compresa,ma non solo,la depressione clinica,potenzialmente in grado di interferire con la partecipazione del soggetto allo studio.11.Ipertensione non controllata in occasione della SV,in qualsiasi momento durante il periodo di screening o il giorno 1.12.Anamnesi di malattia endocrinologica,ematologica,immunologica,metabolica,urologica,neurologica,dermatologica o altra malattia maggiore clinicamente significativa.13.Valori anomali di laboratorio clinicamente significativi.14.Indice di massa corporea ≥40.15.Uso di trattamenti SM fuori etichetta,compresi rituximab,alemtuzumab,daclizumab o anticorpi(ad eccezione del natalizumab) entro i 3 mesi che precedono la SV o in qualsiasi momento durante il periodo di screening oppure il trattamento previsto durante la partecipazione allo studio.16.Uso di mitoxantrone o ciclofosfamide entro i 3 mesi che prima della SV o in qualsiasi momento durante il periodo di screening oppure il trattamento previsto durante la partecipazione allo studio.17.Inizio di trattamento a base di natalizumab o eventuali modifiche della dose del soggetto o del regime di natalizumab, entro i 3 mesi che precedono la SV o in qualsiasi momento durante il periodo di screening.18.Inizio di trattamento a base di interferone β-1b,β-1a,fingolimod o glatiramer acetato o eventuali modifiche della dose del soggetto o del regime di trattamento entro i 30 giorni prima della SV o in qualsiasi momento durante il periodo di screening.19.Trattamento a base di steroidi pulsati entro i 60 giorni prima della SV o in qualsiasi momento durante il periodo di screening.20.Modifica della dose o del regime del farmaco per il trattamento di affaticamento o depressione entro i 30 giorni che precedono la visita di screening o in qualsiasi momento durante il periodo di screening.21.Modifica del trattamento profilattico del dolore con antidepressivi o anticonvulsivi prescritti entro i 30 giorni prima della SIV o in qualsiasi momento durante il periodo di screening.22.Modifica della dose o del regime di antispastici entro i 7 giorni prima della SV o in qualsiasi momento durante il periodo di screening.23. Trattamento con un farmaco sperimentale entro i 30 giorni prima della SV o in qualsiasi momento durante il periodo di screening.24.Trattamento a base di 4-AP o 3,4-DAP in qualsiasi formulazione entro i 30 giorni prima della SV o in qualsiasi momento durante il periodo di screening.25.Anamnesi di abuso di droghe o alcol entro i 2 anni prima della SV.26.Donne in gravidanza o che pianificano una gravidanza durante lo studio.27.Donne in fase di allattamento.28.Incapacità di osservare i requisiti dello studio.29.Attuale arruolamento in qualsiasi altro studio clinico
    E.5 End points
    E.5.1Primary end point(s)
    The endpoints of this study are as follows: 1)Change from baseline in self-assessed walking disability up to Week 24 as reported on the MSWS-12. 2)Change from baseline in balance up to Week 24 as assessed by the BBS and the TUG. 3)Change from baseline in subjective impression of well-being (MSrelated QoL) up to Week 24 as measured by the MSIS-29 physical subscale and the EuroQoL descriptive system of health-related quality of life states consisting of 5 dimensions (EQ-5D [The EuroQol Group 1990]). 4)Subjects' global impression of change in walking as reported on the PGIC scale.5)Safety of prolonged-release fampridine as assessed by the following: the number and proportion of subjects with AEs and serious AEs (SAEs) clinical laboratory parameters vital signs physical examination assessment of electrocardiograms (ECGs)
    Gli endpoint del presente studio sono i seguenti: -Variazione rispetto al basale nella disabilita' deambulatoria autovalutata fino alla settimana 24, riportata sulla scala MSWS-12. -Variazione rispetto al basale nell'equilibrio fino alla settimana 24, valutata sulla scala BBS e dal test TUG. -Variazione rispetto al basale nell'impressione soggettiva di benessere (QoL correlata alla SM) fino alla settimana 24, valutata sulla scala secondaria fisica della scala MSIS-29 e dal sistema descrittivo della qualita' di vita in termini di stato di salute, costituito da 5 dimensioni, EuroQoL (EQ-5D [The EuroQol Group, 1990]). -Impressione globale dei soggetti relativa a variazioni nella deambulazione fino alla settimana 24, riportata sulla scala PGIC. -Sicurezza della fampridina a rilascio prolungato, valutata da quanto segue:-numero e proporzione dei soggetti colpiti da eventi avversi (EA) e da eventi avversi seri (SAE),-parametri clinici di laboratorio,-parametri vitali,-esame obiettivo,-valutazione di elettrocardiogrammi (ECG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1)Screening Visit, Day 1, Weeks 2, 4, 8,12,16,24 and Week 26 and Unscheduled Visit(s) 2)Screening Visit, Day 1, Weeks 2,4,8, 12,16,24 and Week 26 3)MSIS-29 = Screening Visit, Day 1, Weeks 2,4,8,12,16, and 24. EQ-5D = Day 1, Weeks 4, 8, 12, 16, 20 and 24. 4)Weeks 2, 4, 8,12, 16, 20 and 24. 5)The number and proportion of subjects with AEs and serious AEs (SAEs)=Monitor and record throughout the study. Clinical laboratory parameters=Screening Visit, Day 1, Weeks 2, 4, 8,12, 16, 24 and Week 26 and Unscheduled Visit(s). Vital signs= Screening Visit, Day 1, Weeks 4, 24 and Week 26 and Unscheduled Visit(s). Physical examination=Screening Visit, Day 1, Weeks 24 and Week 26 and Unscheduled Visit(s). Assessment of electrocardiograms (ECGs) = Screening Visit and week 26
    1)Visita di screening,giorno 1,settimane 2,4,8,12,16,24 e 26 e visita non programmata 2)Visita di screening,giorno 1,settimane 2,4,8,12,16,24 e 26 3)MSIS-29= Visita Screening, Giorno 1, settimane 2,4,8,12,16 e 24.EQ-5D=Giorno 1, settimane 4,8,12,16,20 e 24 4)settimane 2,4,8,12,16,20 e 24. 5)Il numero e la proporzione di soggetti con eventi avversi e(SAE) = monitorare e registrare per tutto lo studio. Parametri clinici di laboratorio=Visita di screening,giorno 1,settimane 2,4,8,12,16,24 e 26 e visita non programmata.Segni vitali=Visita di Screening,giorno 1, settimane 4, 24 e 26 e visita non programmata.Esame fisico=Visita di Screening,giorno 1, settimane 4, 24 e 26 e visita non programmata.Valutazione ECG=Visita di Screening,Settimana 26
    E.5.2Secondary end point(s)
    not applicable
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Canada
    Switzerland
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 120
    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)
    No further provisions are made for access to the study treatment
    Non sono previste ulteriori disposizioni per l'accesso al trattamento studio
    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 Decision2012-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-09
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