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    Summary
    EudraCT Number:2013-002283-25
    Sponsor's Protocol Code Number:EMR200575-001
    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:2013-10-08
    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 number2013-002283-25
    A.3Full title of the trial
    A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study To Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis
    Studio di fase II, randomizzato, multicentrico, a gruppi paralleli, in cieco per colui che valuta, per valutare l’efficacia, la sicurezza e la tollerabilità di Plovamer Acetato in dosi da 0,5 mg, 3 mg, 10 mg e 20 mg rispetto a Copaxone in pazienti affetti da sclerosi multipla recidivante remittente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis
    Studio per valutare l’efficacia, la sicurezza e la tollerabilità di Plovamer Acetato rispetto a Copaxone in pazienti affetti da sclerosi multipla recidivante remittente.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, safety, and tolerability of plovamer acetate
    Efficacia, sicurezza e tollerabilità di Plovamer Acetato
    A.4.1Sponsor's protocol code numberEMR200575-001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurterstrasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.6E-mailservice@merckgroup.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePlovamer acetate
    D.3.2Product code MSC2491529A
    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.3.8INN - Proposed INNND
    D.3.9.1CAS number ND
    D.3.9.2Current sponsor codeMSC2491529A
    D.3.9.3Other descriptive namePlovamer acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePlovamer acetate
    D.3.2Product code MSC2491529A
    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.3.8INN - Proposed INNND
    D.3.9.1CAS number ND
    D.3.9.2Current sponsor codeMSC2491529A
    D.3.9.3Other descriptive namePlovamer acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePlovamer acetate
    D.3.2Product code MSC2491529A
    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.3.8INN - Proposed INNND
    D.3.9.1CAS number ND
    D.3.9.2Current sponsor codeMSC2491529A
    D.3.9.3Other descriptive namePlovamer acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 4
    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 Copaxone
    D.2.1.2Country which granted the Marketing AuthorisationIsrael
    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.3.8INN - Proposed INNGlatiramer acetate
    D.3.9.1CAS number 147245-92-9
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Relapsing Remitting Multiple Sclerosis (RRMS)
    sclerosi multipla recidivante remittente (RRMS).
    E.1.1.1Medical condition in easily understood language
    Relapsing Remitting Multiple Sclerosis (RRMS)
    sclerosi multipla recidivante remittente (RRMS).
    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 16.0
    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 this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS.
    Valutare l’efficacia di plovamer acetato (0,5 mg, 3 mg, 10 mg e 20 mg) somministrato in iniezioni sottocutanee (s.c.) settimanali rispetto a Copaxone (20 mg) somministrato come iniezione s.c. giornaliera dopo 40 settimane di trattamento sulla base del numero medio di lesioni captanti gadolinio (GD) pesate in T1 per paziente, e della scansione cerebrale mediante risonanza magnetica per immagini (RMI) alle Settimane 24, 28, 32, 36 e 40 in pazienti affetti da sclerosi multipla remittente recidivante (relapsing remitting multiple sclerosis, RRMS).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg), administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment
    Valutare l’efficacia di plovamer acetato (0,5 mg, 3 mg, 10 mg e 20 mg) somministrato in iniezioni s.c. settimanali rispetto a Copaxone (20 mg) somministrato come iniezione s.c. giornaliera s.c. dopo 40 settimane di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, between the ages of 18 and 60 years.
    2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
    3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).

    Other protocol defined inclusion criteria could apply
    1. Pazienti maschi e femmine di età compresa tra 18 e 60 anni
    2. Pazienti in grado di apprendere e di auto-somministrarsi iniezioni SC (un care-giver può essere formato per effettuare l’iniezione al paziente).
    3. Pazienti con attuale diagnosi di RRMS (in base ai criteri diagnostici MS di McDonald 2010).
    Potrebbero essere applicati altri criteri di inclusione definiti dal protocollo.
    E.4Principal exclusion criteria
    Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
    1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
    2. Any relapse of MS within 30 days of the Baseline Visit 2.
    3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
    4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed.)
    5. Contraindication to Copaxone use.

    Other protocol defined exclusion criteria could apply
    1. Qualsiasi SM classificata come progressiva primaria, secondaria progressiva e
    progressiva recidivante.
    2. Qualsiasi ricaduta di SM entro 30 giorni dalla visita 2 basale.
    3. Allergia al mannitolo, plovamer acetato, Copaxone (glatiramer acetato),
    Gd di contrasto per risonanza magnetica.
    4. Terapia con glucocorticoidi sistemici entro 30 giorni dalla visita 2 basale. Qualsiasi
    requisito per la continua somministrazione di glucocorticoidi sistemici
    durante il periodo di prova. (Nota: Il trattamento con interferoni come
    Avonex ®, Rebif ®, o Betaseron ® sarà consentito fino alla visita basale,
    poichè non è necessario alcun periodo di wash-out.)
    5. Controindicazione all'uso Copaxone.

    Potrebbero essere applicati altri criteri di esclusione definiti dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean number of T1 Gd-enhancing lesions per patient per scan measured over 5 monthly visits (Weeks 24, 28, 32, 36 and 40).
    Numero medio di nuove lesioni captanti il Gd pesate in T1 per paziente per scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
    E.5.1.1Timepoint(s) of evaluation of this end point
    40 weeks
    40 settimane
    E.5.2Secondary end point(s)
    Mean Annualized Relapse Rate.
    · Percentage of patients remaining relapse-free at
    Week 40.
    · Mean number of new T1 Gd-enhancing lesions per
    patient and scan from 5 serial MRI scans performed on
    Weeks 24, 28, 32, 36, and 40.
    · Mean number of new or enlarging T2 lesions per patient and scan from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
    · Mean number of new, unenhancing T1 lesions (black holes) per patient and scan on MRI scans from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.
    · Mean change in volume of T1 Gd-enhancing lesions per patient baseline vs. mean of 5 serial MRI scans performed on Weeks 24, 28, 32, 36, and 40.
    · Mean change per patient in volume of T2 Gd-enhancing lesions baseline vs. last MRI scan performed between Weeks 24 and 40.
    · Time to first relapse.
    · Mean change in brain volume per patient baseline vs. last MRI performed between Weeks 24 and 40.
    • Tasso annuale di recidive (ARR) medio alla Settimana 40.
    • Percentuale di pazienti rimasti privi di recidiva alla Settimana 40.
    • Numero medio di nuove lesioni captanti il Gd pesate in T1 per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
    • Numero medio di nuove lesioni o di lesioni in crescita pesate in T2 per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
    • Numero medio di nuove lesioni non captanti pesate in T1 (buchi neri) per paziente e scansione da 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
    • Variazione media in volume di lesioni captanti il Gd pesate in T1 per paziente al basale rispetto alle scansioni medie di 5 RMI seriali eseguite alle Settimane 24, 28, 32, 36 e 40.
    • Variazione media per paziente nel volume di lesioni captanti il Gd pesate in T2 al basale rispetto all’ultima scansione RMI eseguita tra le settimane 24 e 40.
    • Tempo alla prima recidiva.
    • Variazione media nel volume cerebrale per paziente al basale rispetto all’ultima RMI eseguita tra le Settimane 24 e 40.
    E.5.2.1Timepoint(s) of evaluation of this end point
    40 weeks
    40 settimane
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in cieco per colui che valuta (rater blinded)
    Rater blinded
    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 trial5
    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
    Bulgaria
    Colombia
    Croatia
    Czech Republic
    Finland
    Greece
    Hungary
    Italy
    Mexico
    Poland
    Serbia
    South Africa
    Spain
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 550
    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 335
    F.4.2.2In the whole clinical trial 550
    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 Decision2013-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-03
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