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    Summary
    EudraCT Number:2005-004061-41
    Sponsor's Protocol Code Number:101-MS-321
    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:2006-04-21
    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 number2005-004061-41
    A.3Full title of the trial
    An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation
    Studio di estensione multicentrico in aperto per valutare la sicurezza e la tollerabilita` di Natalizumab dopo ripresa di somministrazione in soggetti con sclerosi multipla che hanno completato gli studi C-1801 o C-1802 ed una valutazione della sicurezza dopo sospensione della somministrazione del prodotto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment
    Studio di estensione con Natalizumab per i pz gia` inseriti negli studi C-1801 e 1802 al fine di valutare la sicurezza del trattamento
    A.3.2Name or abbreviated title of the trial where available
    STRATA
    STRATA
    A.4.1Sponsor's protocol code number101-MS-321
    A.5.4Other Identifiers
    Name:EUDRACTNumber:2005-004061-41
    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 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 LTD
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOGEN IDEC LTD
    B.5.2Functional name of contact pointRegulatory affairs
    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.5.4Telephone number0044-1628-501000
    B.5.5Fax number0044-1628-501010
    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 Yes
    D.2.1.1.1Trade name Tysabri
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN IDEC LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Concentrate 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.3.9.2Current sponsor codeBG00002
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    sclerosi multipla
    sclerosi multipla
    E.1.1.1Medical condition in easily understood language
    sclerosi multipla
    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 14.1
    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 objectives of this study are to further evaluate the safety of natalizumab monotherapy by: - evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and - confirming the safety of switching from IFNì, GA, or other MS therapies to natalizumab. For the Long-Term Treatment Period: Primary: The primary objective for the Long-Term Treatment period of this study is to evaluate the long term impact of natalizumab monotherapy on the progression of disability measured by EDSS changes over time.
    Gli obiettivi primari di questo studio consistono nell`ulteriore valutazione della sicurezza di natalizumab in monoterapia attraverso: - una valutazione del rischio di ipersensibilita` e della immunogenicita` dopo ripresa della somministrazione di natalizumab, e - una conferma della sicurezza di un passaggio da IFN, GA, o da altre terapie per la SM ad una terapia con natalizumab. Per il periodo di estensione del trattamento l`obiettivo e` di valutare l`impatto a lungo termine della monoterapia con natalizumab sulla progressione della disabilita` misurata mediante cambiamento nel punteggio EDSS nel tempo
    E.2.2Secondary objectives of the trial
    - the feasibility of a methodology for early detection and differentiation of PML from MS in subjects who develop new neurological symptoms or signs while on natalizumab therapy - whether serial blood testing can be used to monitor the presence of JC virus (JCV) in the MS population, and - an approach to testing for persistent anti-natalizumab antibodies. The secondary objectives for the Long-Term Treatment period of this study are to: measure the frequency of relapses, (MS relapses are defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours and following a period of improvement or stabilization of symptoms of at least 30 days), evaluate the safety and tolerability of natalizumab, estimate the seroconversion rates of JCV antibody in MS patients over time
    - la fattibilita` di una metodologia per la diagnosi precoce e la differenziazione della PML dalla SM in soggetti che presentano nuovi sintomi o segni neurologici durante la terapia con natalizumab- l`utilita` di esami ematici per monitorare la presenza di virus JC (JCV) nella popolazione con SM,e- un approccio di test per gli anticorpi anti-natalizumab persistenti.Per il periodo di estensione del trattamento l`obiettivo e` di valutare la frequenza di ricadute della SM,la sicurezza e tollerabilita` di natalizumab,stimare i tassi di sieroconversione nel tempo degli anticorpi anti JVC nei pz con SM trattati con natalizumab Sezione 6.2.2,Obiettivi supplementari per il periodo di trattamento a lungo termine Modifica: aggiunta dei seguenti obiettivi supplementari: (1) valutare le fluttuazioni nel tempo del titolo di anticorpi anti-JCV (2) studiare una strategia per l`uso de
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    in the protocol is indicated ``optional blood sample for genetic testing `` The purpose is to explore host genetic mutations that may render individual subjects more suscepible/resistant to PML

    ALTRI SOTTOSTUDI:
    All`interno del protocollo e` indicato ``optional blood sample for genetic testing `` Lo scopo e` di esplorare host genetic mutations che possono rendere il soggetto piu` suscettibile/resistente a PML

    E.3Principal inclusion criteria
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit: 1. must give written informed consent and provide all authorizations required by local law 2. must be an MS subject who completed Study C-1801 or C-1802 and completed a Dosing Suspension Safety Evaluation (neurological examination and an MRI scan) -partecipated in study IMA04001(STARS) or completed 48 weeks of treatment in study 101-MS-322 in Canada-these subjects will be allowed to enter this study at start of long term treatment period 3. must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used) 4. must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN and GA) for the duration of the study. NOTE: Subjects who were found to be on placebo after being unblinded for a serious adverse event (SAE) in Study C-1801 or C-1802 are eligible to enroll in this study if they completed a Dosing Suspension Safety Evaluation, receive approval from the Biogen Idec Medical Director or the relevant Advisory Committee, meet all other inclusion criteria for this study, and are not excluded based on the exclusion criteria for this study.
    A meno che non sia specificato altrimenti, per essere idoneo a partecipare allo studio il candidato deve rispettare i seguenti criteri di eleggibilità alla visita di screening: 1. deve dare il suo consenso informato scritto e tutte le autorizzazioni richieste dalla normativa locale vigente 2. deve essere affetto da SM, aver completato lo studio C-1801 o lo studio C-1802 ed aver completato una Valutazione di sicurezza dopo sospensione della somministrazione del prodotto (esame neurologico e scan di risonanza magnetica per immagini)- aver partecipato allo studio IMA 04001 (STARS) o aver completato 48 settimane di trattamento nello studio 10-MS-322 in Canada.I soggetti potranno entrare nello studio all`inizio del periodo di trattamento a lungo termine. 3. deve essere considerato dallo sperimentatore privo di segni o sintomi indicativi di PML sulla base della anamnesi, esame fisico ed esami di laboratorio (possono essere utilizzati i risultati della Valutazione di sicurezza dopo sospensione della somministrazione del prodotto del protocollo C-1808) 4. deve voler sospendere e continuare a non assumere terapie concomitanti immunosuppressive o immunomodulatori (inclusi IFN e GA) per tutta la durata dello studio. NOTA: I soggetti che si e` scoperto essere stati trattati con placebo dopo l`apertura del cieco a seguito di un evento avverso serio (SAE) nello studio C-1801 o C-1802 sono eleggibili per l`arruolamento in questo studio se completano una Valutazione di sicurezza dopo sospensione della somministrazione del prodotto, ricevono approvazione dal Direttore Medico di Biogen Idec o dal rispettivo Comitato Consultivo, rispettano tutti gli altri criteri di inclusione per questo studio, e non devono essere escusi sulla base dei criteri di esclusione.
    E.4Principal exclusion criteria
    1. considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment 2. history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies 3. history of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent . The Investigator must re-review the subject`s medical fitness for participation and consider any diseases that would preclude treatment. 4. history of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible) 5. known history of human immunodeficiency virus infection or hematological malignancy 6. history of organ transplants 7. history of severe allergic or anaphylactic reactions or known drug hypersensitivity 8. a significant change (as determined by the Investigator) in the subject`s medical history from their previous natalizumab study 9. a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit in Study 101-MS-321 10. discontinued natalizumab in a previous study due to allergic reaction or any other SAE considered to be related to natalizumab treatment 11. discontinued study drug in Study C-1801 or C-1802 because of an AE or due to reasons other than significant disease progression (as defined in the C-1801 and C-1802 protocols) 12. treatment with immunosuppressant medications (e.g. mitoxantrone, etc) within 3 months prior to screening 13.female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception (as defined by the Investigator) during the study 14. women who are breastfeeding, pregnant, or planning to become pregnant while on study are excluded until post-prgnancy/cessation of breastfeeding 15. current enrollment in any other study treatment or disease study 16. unwillingness or inability to comply with the requirements of this protocol, 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 17. other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.
    A meno che non sia specificato altrimenti, i candidati saranno esclusi dallo studio se esiste uno qualsiasi dei seguenti criteri di esclusione in qualunuque momento durante la visita di screening: Anamnesi 1. valutazione dei soggetti come immunocompromessi a giudizio dello sperimentatore, sulla base dell`anamnesi, dell`esame fisico, o degli esami di laboratorio (possono essere utilizzati i risultati della Valutazione di sicurezza dopo sospensione della somministrazione del prodotto del protocollo C-1808), o a seguito di un precedente trattamento immunosoppressivo 2. anticorpi persistenti anti-natalizumab in anamnesi, sulla base di valutazioni precedenti a studi con natalizumab 3. anamnesi o risultati di laboratorio anormali indicativi di qualsiasi tipo di patologia cardiaca, endocrinologica, ematologica, epatica, immunologica, metabolica, urologica, polmonare, gastrointestinale, dermatologica, psichiatrica (inclusa la depressione maggiore), renale e/o altre patologie significative che precluderebbero la somministrazione di un anticorpo ricombinante umanizzato immunomodulatore . Lo sperimentatore deve riverificare che il soggetto sia in buona forma dal punto di vista medico per partecipare allo studio e tenere in considerazione qualunque tipo di patologia che potrebbe precludere al trattamento. 4. anamnesi di tumori maligni (soggetti con carcinoma delle cellule basali asportato completamente prima dell`arruolamento nello studio rimangono eleggibili) 5. anamnesi conosciuta di immunodeficienza data da infezione virale o neoplasia e matologica 6. anamnesi di trapianti d`organo 7. anamnesi di reazioni allergiche o anafilattiche importanti o nota ipersensibilità a farmaci 8. una modifica significativa (a giudizio dello sperimentatore) nella storia clinica del paziente rispetto allo studio precedente con natalizumab 9. una patologia infettiva clinicamente significativa (es: infiammazione del tessuto connettivo sottocutaneo, ascessi, polmonite, setticemia) nei 30 giorni che precedono la visita di screening per lo studio 101-MS-321 Terapie precedenti 10. natalizumab deve essere stato sospeso negli studi precedenti a causa di una reazione allergica o a qualsiasi tipo di evento avverso serio considerato correlate all`uso di natalizumab 11. il farmaco in studio negli studi C-1801 or C-1802 deve essere stato sospeso a causa di un evento avverso o per una ragione diversa da una progressione di malattia significativa (come definito nei protocolli C-1801 e C-1802) Varie 12. trattamento con farmaci immunosoppressivi come es. mitoxantrone ,etc entro i 3 mesi precedenti allo screeening 13. donne non in post-menopausa da almeno un anno, non chirurgicamente sterili (non inclusa legatura delle tube), o che non vogliano adottare metodi contraccettivi (come descritto dallo sperimentatore) durante lo studio 14. donne che siano in allattamento, che siano in stato di gravidanza o che vogliano iniziare una gravidanza nel corso dello studio sono escluse fino al completemento della gravidanza/cessazione allattamento 15. arruolamento concomitante in un qualsiasi altro studio con trattamento sperimentale o patologia in studio 16. soggetti che non vogliano o non siano in grado di rispettare i requisiti del presente protocollo, inclusa la presenza di una qualsiasi condizione (fisica, mentale o sociale) che potrebbe presumibilmente influire sulla capacità del soggetto di osservare il protocollo di studio 17. altre ragioni, non meglio specificate che, a giudizio dello sperimentatore e/o di Biogen Idec, rendano il soggetto non eleggibile per lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    To Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety EvaluationThe primary objective for the Long-Term Treatment period of this study is to evaluate the long term impact of natalizumab monotherapy on the progression of disability measured by EDSS changes over time.
    Valutare la sicurezza e la tollerabilita` di Natalizumab dopo ripresa della somministrazione in soggetti con sclerosi multipla che hanno completato lo Studio C-1801 o C-1802 ed una Valutazione di sicurezza dopo sospensione della somministrazione del prodotto.Per il periodo di estensione del trattamento l`obiettivo e` di valutare l`impatto a lungo termine della monoterapia con natalizumab sulla progressione della disabilita` misurata mediante cambiamento nel punteggio EDSS nel tempo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly evaluations up to the end of the study
    Valutazione mensile fino alla fine dello studio
    E.5.2Secondary end point(s)
    additional objectives for the Long-Term Treatment period of this study are to: • measure the frequency of relapses (MS relapses are defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours and following a period of improvement or stabilization of symptoms of at least 30 days) • evaluate the safety and tolerability of natalizumab • estimate the seroconversion rates of and fluctuations over time of anti-JCV antibody in MS patients over time as an optional substudy, explore axial FLAIR MRI as a potential screening tool for PML every 12 weeks for PML lesions in subjects with more than 2 years of natalizumab therapy and prior IS therapy. The types of prior IS therapy include: mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab, and chemotherapy (not otherwise specified). • as an optional substudy, the collection of post-PML biological samples for research into PML risk stratification in the event that PML is strongly suspected or confirmed. • as an optional substudy, to explore host genetic mutations
    • misurare la frequenza delle recidive (le recidive di SM sono definite come sintomi neurologici nuovi o ricorrenti, non accompagnati da febbre, della durata di almeno 24 ore, e successive ad un periodo di almeno 30 giorni di miglioramento o stabilizzazione dei sintomi) • valutare la sicurezza e la tollerabilita' di natalizumab • stimare i tassi di sieroconversione e le fluttuazioni nel tempo dell’anticorpo anti-JCV nei pazienti con SM come sottostudio opzionale, esaminare la tecnica FLAIR MRI assiale come possibile strumento di screening per la PML usata ogni 12 mesi alla ricerca di lesioni da PML in soggetti che seguono da oltre 2 anni una terapia con natalizumab preceduta da un trattamento immunosoppressivo. I possibili trattamenti immunosoppressivi precedenti sono: mitoxantrone, azatioprina, metotressato, ciclofosfamide, micofenolato, cladribina, rituximab e chemioterapia (non altrimenti specificata). • come sottostudio opzionale, raccolta di campioni biologici post-PML per ricercare la stratificazione del rischio di PML nel caso in cui ci sia un forte sospetto o certezza di PML. • come sottostudio opzionale, ricercare le mutazioni genetiche del portatore
    E.5.2.1Timepoint(s) of evaluation of this end point
    evaluations to be done every 6/12 months
    valutazioni da effettuarsi ogni 6/12 mesi
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA80
    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
    New Zealand
    Switzerland
    Turkey
    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 years10
    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 years10
    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.1.3Elderly (>=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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 700
    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 Decision2006-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-30
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