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    Summary
    EudraCT Number:2010-024000-10
    Sponsor's Protocol Code Number:101MS206
    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:2011-12-27
    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 number2010-024000-10
    A.3Full title of the trial
    A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
    Studio randomizzato di fase II, in cieco, a gruppi paralleli, teso a valutare la sicurezza, la tollerabilita' e l' efficacia di dosaggi multipli di natalizumab in soggetti adulti affetti da sclerosi multipla recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
    Studio randomizzato di fase II, in cieco, a gruppi paralleli, teso a valutare la sicurezza, la tollerabilita' e l’efficacia di dosaggi multipli di natalizumab in soggetti adulti affetti da sclerosi multipla recidivante
    A.4.1Sponsor's protocol code number101MS206
    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 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 Limited
    B.5.2Functional name of contact pointnon disponibile
    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.5.3.4CountryItaly
    B.5.4Telephone numbernon disponibile
    B.5.5Fax numbernon disponibile
    B.5.6E-mailneurologyclinicaltrial@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*IV 1FL 300MG 15ML
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN DOMPE' Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.9.1CAS number 189261-10-7
    D.3.9.2Current sponsor codeAN100226; BG00002
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    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 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*IV 1FL 300MG 15ML
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN DOMPE' Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 189261-10-7
    D.3.9.2Current sponsor codeAN100226; BG00002
    D.3.9.4EV Substance CodeSUB22282
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    sclerosi multipla recidivante remittente
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis characterized by unpredictable relapses followed by periods with no new signs of disease activity
    sclerosi multipla caratterizzata da imprevedibili ricadute seguiti da periodi seguiti da periodi con nessun segno di attività della malattia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the effects of multiple regimens of natalizumab on disease activity and safety in subjects with relapsing remitting MS.
    Esaminare gli effetti di dosaggi multipli di natalizumab sull’attività della malattia, nonché la sua sicurezza in soggetti affetti da sclerosi multipla recidivante remittente.
    E.2.2Secondary objectives of the trial
    • To characterize and compare PK/PD profiles across multiple dose regimens of natalizumab. • To characterize effects on secondary brain MRI measures. • To evaluate potential laboratory markers of immune function and trafficking across the treatment regimens. • To assess the safety and tolerability across multiple dose regimens.
    •Caratterizzare e confrontare i profili PK/PD attraverso regimi di dosaggio multipli di natalizumab. •Caratterizzare gli effetti sulle rilevazioni secondarie cerebrali mediante RMI. •Valutare i possibili marcatori di laboratorio associati alla funzione immunitaria e al traffico linfocitario attraverso i regimi di trattamento considerati. •Determinare la sicurezza e la tollerabilità attraverso regimi di dosaggio multipli.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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. Aged 18 to 55 years old, inclusive, at the time of informed consent. 3. Subjects of childbearing potential must practice effective contraception during the study. 4. A documented diagnosis of RRMS. 5. Free of MS relapse, as determined by the enrolling Investigator, for 12 months prior to randomization. 6. Treatment with natalizumab according to locally approved pescribing information for a minimum of the 12 months immediately prior to randomization. The subject must have received at least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization. 7. In the 12 months prior to the initiation of natalizumab, subject must have experienced a minimal level of disease activity as defined by:• 2 or more documented clinical relapses OR • 1 relapse and documented MRI activity, defined by the presence of at least one Gd enhancing lesion on MRI, unrelated to the relapse.
    1.Capacità di comprendere lo scopo e i rischi associati allo studio, fornire un consenso informato datato e firmato e l’autorizzazione all’utilizzo di informazioni sanitarie protette (PHI) in conformità con le normative nazionali e locali riguardanti la privacy del soggetto. 2.Età dai 18 ai 55 anni inclusi, al momento del consenso informato. 3.Le donne in età fertile dovranno far uso di un metodo anticoncezionale efficace durante il periodo di partecipazione allo studio (vedi Sezione 15.5.3). 4.Una diagnosi documentata di SM-RR. 5.Il soggetto deve essere stato libero da recidiva di SM, come determinato dallo sperimentatore arruolatore, per i 12 mesi precedenti la randomizzazione. 6.Trattamento con natalizumab in conformità con informazioni di prescrizione localmente approvate per un minimo di 12 mesi immediatamente prima della randomizzazione. Il soggetto deve aver ricevuto almeno 11 dosi di natalizumab nei 12 mesi prima della randomizzazione senza aver saltato dosi nei 3 mesi prima della randomizzazione. 7.Nei 12 mesi prima dell’avvio a natulizumab, il soggetto deve aver provato un livello minimo di attività patologica, come definita di seguito: •2 o più recidive cliniche documentate OPPURE •1 recidiva e attività RMI documentata, definita dalla presenza di almeno una lesione captante il gadolinio su RMI, non correlata alla recidiva.
    E.4Principal exclusion criteria
    1.Known history of Human Immunodeficiency Virus (HIV). 2.Known history of hepatitis C (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]). 3.Positive for anti-natalizumab antibodies at Screening. 4.MRI positive for Gd-enhancing lesions at study entry. 5.Subjects for whom MRI is contraindicated, e.g., have a pacemaker or other contraindicated implanted metal devices, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed. 6.History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic,immunologic, metabolic (including diabetes), urologic, pulmonary,neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study. 7.History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). 8.History of transplantation or any anti-rejection therapy. 9.History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug. 10.A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to Screening, or PML or other opportunistic infections at any time. 11.Signs or symptoms suggestive of any serious infection, based on medical history, physical examination, or laboratory testing, as determined by the Investigator. MS Treatment History 12.Prior treatment with total lymphoid irradiation. 13.Prior treatment with cladribine, mitoxantrone, fingolimod, T-cell or T-cell receptor vaccination, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic monoclonal antibody other than natalizumab within 24 months prior to randomization. 14.Prior treatment with intravenous immunoglobulin (IVIg), plasmapheresis, or cytapheresis within 12 months prior to randomization. 15.Treatment with IV or oral corticosteroids (topical corticosteroids are acceptable) or related products within 3 months prior to randomization. Miscellaneous 16.Female subjects considering becoming pregnant while in the study. 17.Female subjects who are pregnant or currently breastfeeding. 18.History of drug or alcohol abuse within 2 years prior to entry per Investigator judgment. 19.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. 20.Receiving any other investigational treatment witwithin the 12 months prior to Screening or concurrent with this study.21. Any pre-scheduled elective procedure during the study period that,in the opinion of the Investigator, would interfere with study endpoints. 22.Any other condition, clinical finding, or reason that, in the opinion of the Investigator and/or the Sponsor, makes the subject unsuitable for enrollment into this study. 23.Previous participation in this study at randomization.
    1.Anamnesi nota di virus dell’immunodeficienza umana (HIV). 2.Anamnesi nota di epatite C (esame per anticorpo del virus dell’epatite C [HCV Ab]) o virus dell’epatite B (esame per antigene di superficie del virus dell’epatite B [HBsAg] e/o anticorpo contro l’antigene del core dell’epatite B [HBcAb]). 3.Positivo per anticorpi anti-natalizumab allo screening. 4.RMI positiva per lesioni captanti il gadolinio all’arruolamento allo studio. 5.I soggetti per i quali una RMI sia controindicata, ad esempio, se hanno un pacemaker o altri apparecchi metallici impiantati controindicati, se hanno sofferto, o se sono a rischio di, effetti collaterali causati dal gadolinio, o se soffrono di claustrofobia non gestibile clinicamente. 6.Anamnesi clinicamente significativa (a giudizio dello sperimentatore) di malattia cardiaca, endocrinologica, ematologica, epatica, immunologica, metabolica (compreso diabete), urologica, polmonare, neurologica (ad eccezione di SM-RR), dermatologica, psichiatrica, renale o altra malattia maggiore che possa precludere la partecipazione allo studio clinico. 7.Anamnesi di malattia maligna, compresi tumori solidi e malignità ematologiche (ad eccezione di carcinomi cutanei a cellule basali e a cellule squamose completamente asportati e considerati curati). 8.Anamnesi di trapianto o qualsiasi terapia anti-rigetto. 9.Anamnesi di gravi reazioni allergiche o anafilattiche oppure nota ipersensibilità a qualsiasi farmaco. 10.Una malattia infettiva clinicamente significativa (ad esempio, cellulite, ascesso, polmonite, setticemia) nei 30 giorni precedenti allo screening, oppure leucoencefalopatia progressiva multifocale (PML) o altre infezioni opportunistiche in qualsiasi momento. 11.Segni o sintomi che suggeriscono un’infezione grave qualsiasi, in base ad anamnesi medica, esame obiettivo o esame di laboratorio, come stabilito dallo Sperimentatore. Storia del trattamento per la SM 12.Trattamento pregresso con irradiazione linfoide totale. 13.Trattamento pregresso con cladribina, mitoxantrone, fingolimod, vaccinazione con cellule-T o con recettore delle cellule-T, ciclofosfamide, ciclosporina, azatioprina, metotrexato, micofenolato mofetile, o qualsiasi anticorpo monoclonale terapeutico ad eccezione di natalizumab nei 24 mesi precedenti alla randomizzazione. 14.Trattamento pregresso con immunoglobulina (IVIg) per endovena, plasmaferesi o citoferesi nei 12 mesi precedenti alla randomizzazione. 15.Trattamento con corticosteroidi orali o EV (corticosteroidi topici sono accettabili) oppure prodotti correlati nei 3 mesi precedenti alla randomizzazione. Varie 16.Soggetti di sesso femminile che contemplano una gravidanza durante il corso dello studio. 17.Soggetti di sesso femminile in gravidanza o in allattamento. 18.Anamnesi di abuso di stupefacenti o di alcol nei 2 anni precedenti all’arruolamento, a giudizio dello Sperimentatore. 19.Mancanza di volontà o inabilità a soddisfare le richieste di questo protocollo, compresa la presenza di qualsiasi condizione (fisica, mentale o sociale) che possa incapacitare il soggetto ad attenersi al protocollo dello studio. 20.Assunzione di un altro trattamento sperimentale nei 12 mesi precedenti lo screening o contemporaneamente a questo studio. 21.Qualsiasi procedura elettiva precedentemente programmata durante il corso dello studio che, a giudizio dello Sperimentatore, potrebbe interferire con gli endpoint dello studio. 22.Qualsiasi altra condizione, accertamento clinico o ragione che, a giudizio dello Sperimentatore e/o dello Sponsor, potrebbe rendere il soggetto non idoneo all’arruolamento nel presente studio. 23.Precedente partecipazione a questo studio al momento della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of combined unique active lesions (sum of the number of new Gd enhancing and new or newly enlarging T2 hyperintense lesions not associated with Gd enhancement on T1 weighted scans) based on brain MRI scans conducted on weeks 12, 24, 36, 48 e 60.
    Numero cumulativo di lesioni attive uniche e combinate (desunte dalla somma del numero di nuove lesioni captanti il Gd o nuove lesioni iperintense in T2 di recente espansione non associate a Gd-enhancement con sequenze T1 pesate) osservate mediante scansioni RMI cerebrali condotte alla settimana 12, 24, 36, 48 e 60.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 12, 24, 36, 48 and 60.
    Alle settimane 12, 24, 36, 48 e 60.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned23
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of study is last subject, last visit for final collection of data.
    La fine dello studio è l' ultimo soggetto, l' ultima visita per la raccolta finale dei dati.
    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 months33
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 300
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    non applicabile
    non applicabile
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-18
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