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    Summary
    EudraCT Number:2012-000827-42
    Sponsor's Protocol Code Number:N01372
    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:2012-06-08
    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 number2012-000827-42
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH EPILEPSY
    Studio in aperto, multicentrico, di follow-up per valutare l'efficacia e la sicurezza a lungo termine di brivaracetam usato come trattamento aggiuntivo nei soggetti di eta' uguale o superiore ai 16 anni con epilessia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Trial to look at the long-term safety and effectiveness of
    Brivaracetam used in addition to the subjects main treatment in subjects
    aged 16 years or older with epilepsy
    Studio in aperto per valutare l'efficacia e la sicurezza a lungo termine di Brivaracetam utilizzato in aggiunta al trattamento principale in soggetti di eta uguale o superiore a 16 anni con epilessia
    A.4.1Sponsor's protocol code numberN01372
    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 SponsorUCB PHARMA SA/NV.
    B.1.3.4CountryBelgium
    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 supportUCB PHARMA SA/NV.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 2173 48 1515
    B.5.5Fax number+49 2173 48 1573
    B.5.6E-mailclinicaltrials@ucb.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 nameBrivaracetam
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    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.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 nameBrivaracetam
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 nameBrivaracetam
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 INNBRIVARACETAM
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
    D.3.9.4EV Substance CodeSUB25397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Nonpyschotic Behavioural Side Effects in Subjects With Epilepsy
    Effetti collaterali comportamentali non psicotici in soggetti con epilessia
    E.1.1.1Medical condition in easily understood language
    epilepsy
    epilessia
    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 10015037
    E.1.2Term Epilepsy
    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
    To evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day as adjunctive treatment in adult subjects with epilepsy.
    Valutare la sicurezza e la tollerabilita' a lungo termine di BRV a dosi personalizzate fino a un massimo di 200 mg/die come trattamento adiuvante in soggetti adulti con epilessia.
    E.2.2Secondary objectives of the trial
    To evaluate the maintenance of efficacy of BRV over time
    Valutare il mantenimento dell’efficacia di BRV nel tempo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors. 2.Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted. 3. Subjects having completed the Treatment Period of N01394, or N01395, or other planned BRV Phase 3b studies in epilepsy, and have access to the present study. 4. Subject for whom the Investigator believes a reasonable benefit from the long-term administration of BRV may be expected. 5 Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least ethinylestradiol 30μg, monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods. Abstinence will be considered as an acceptable method of contraception if the Investigator can document that the subject agrees to be compliant. . 6 Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the Investigator.
    1. Il Comitato Etico Indipendente (IEC)/Institutional Review Board (IRB) ha approvato che il modulo di consenso informato sia firmato e datato dal soggetto o dal genitore o rappresentante legale. Il Modulo per il consenso o un modulo di assenso, se necessario, sarà firmato e datata da parte dei minori. 2. Soggetto maschio o femmina di eta' pari o superiore a 16 anni. I soggetti di eta' inferiore ai 18 anni possono essere inclusi solo laddove legalmente permesso ed eticamente accettato. 3. Soggetto che ha completato il periodo di trattamento dello studio N01394 o N01395, o altri studi di fase 3b pianificati con BRV nell’epilessia, e hanno accesso al presente studio. 4. Soggetto per il quale lo Sperimentatore crede che si possa attendere un beneficio ragionevole dalla somministrazione a lungo termine di BRV. 5. I soggetti di sesso femminile non fertili (in post menopausa da almeno 2 anni, con ovariectomia bilaterale o legatura delle tube, isterectomia completa) sono eleggibili. I soggetti di sesso femminile fertili sono eleggibili se usano un metodo contraccettivo accettabile dal punto di vista medico. Trattamento contraccettivo orale o depot con almeno 30 mcg di etinilestradiolo, rapporto monogamo con il partner vasectomizzato o doppia barriera di contraccezione sono metodi accettabili. Astinenza sarà considerato un metodo accettabile se il ricercatore può documentare che il soggetto accetta di essere compliante 6. Il soggetto/il rappresentante legale deve essere considerato affidabile e capace di aderire al protocollo, al programma delle visite, o all’assunzione dei farmaci secondo il giudizio dello Sperimentatore
    E.4Principal exclusion criteria
    • Hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the prior study. • Severe medical, neurological, or psychiatric disorders, or laboratory values that may have an impact on the safety of the subject. • Poor compliance with the visit schedule or medication intake in the previous BRV study. • Planned participation in any other clinical study of another investigational drug or device during this study. • Pregnant or lactating woman. • Any medical condition which, in the Investigator’s opinion, warrants exclusion. • Lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the previous study or at the EV of N01372 if not completed at the last visit of the previous study.
    • Ipersensibilita' ai componenti del prodotto medicinale in studio (IMP) o dei farmaci comparativi come indicato in questo protocollo durante il corso dello studio precedente. • Disturbi gravi medici, neurologici o psichiatrici, o valori di laboratorio che possono avere un impatto sulla sicurezza del soggetto. • Scarsa compliance con il programma delle visite o con l’assunzione del farmaco nel precedente studio su BRV. • Partecipazione pianificata in un altro studio clinico su un altro farmaco o dispositivo sperimentale durante questo studio. • Donne in gravidanza o in allattamento. • Qualsiasi condizione medica che nell’opinione dello Sperimentatore giustifichi l’esclusione. • Storia di tentativo di suicidio (incluso un tentativo attivo, un tentativo interrotto, o un tentativo abbandonato), o paziente che ha avuto un pensiero di suicidio nei 6 mesi precedenti come indicato da una risposta positiva (“Si'”) alla domanda 4 o alla domanda 5 della Scala per la valutazione della gravita' del rischio di suicidio della Columbia (C-SSRS) all’ultima visita dello studio precedente o alla EV dello studio N01372 se non completata all’ultima visita dello studio precedente.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day as adjunctive treatment in adult subjects with epilepsy.
    Valutare la sicurezza e la tollerabilità a lungo termine di BRV a dosi personalizzate fino a un massimo di 200 mg/die come trattamento adiuvante in soggetti adulti con epilessia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Occurrence of a TEAE, 'Withdrawal due to an AE' and 'Occurrence of an SAE' ongoing on a daily basis. Laboratory tests (hematology, blood chemistry, urinalysis), and Vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) every 3 months; and body weight, ECG, and Physical and neurological examinations every 6 months.
    Il verificarsi di una TEAE 'ritiro a causa di un AE', e il verificarsi di un SAE in corso su base giornaliera. I test di laboratorio (ematologia, chimica del sangue, analisi delle urine) e esami obiettivi (pressione arteriosa sistolica e diastolica, frequenza cardiaca) ogni 3 mesi, il peso corporeo, ECG, e esami fisiologici e neurologici ogni 6 mesi.
    E.5.2Secondary end point(s)
    Evaluate the maintenance of efficacy of BRV over time by means of seizure count information recorded on the Daily Record Card. Secondary efficacy variables for subjects with focal-onset epilepsy are the partialonset seizure (POS) (Type I) frequency per 28 days during the Evaluation Period, the percent reduction in POS (Type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period, and the responder rate in POS (Type I) frequency over the Evaluation Period. A responder is defined as a subject with a ≥50% reduction in seizure frequency from the Baseline Period of the previous study. No secondary efficacy variables are defined for subjects with generalized epilepsy. XML File Identifier: MeX8C6bTX4cU5wtsjc+HBL1CQY4= Page 20/29 Other efficacy variables for subjects with focal-onset epilepsy include the percentage of subjects continuously seizure free for all seizure types (I+II+III) for at least 6 months and at least 12 months during the Evaluation Period. Other efficacy variables for subjects with generalized epilepsy include the number of generalized (Type II) seizure days per 28 days during the Evaluation Period, the percent reduction in generalized (Type II) seizure days per 28 days from Baseline of the previous study to the Evaluation Period, the responder rate for generalized (Type II) seizure days over the Evaluation Period, and the percentage of subjects continuously seizure free for all seizure types (I+II+III) for at least 6 months and at least 12 months during the Evaluation Period.
    Valutare il mantenimento dell'efficacia del BRV nel tempo per mezzo di informazioni sul numero delle crisi registrate sulla scheda di registrazione giornaliera. (Daily Record Card). Le variabili secondarie di efficacia sono per i soggetti con epilessia focale le crisi epilettiche ad insorgenza parziale (POS) (Tipo I) frequenza di 28 giorni durante il Periodo di valutazione, la percentuale di riduzione delle POS (Tipo I) frequenza di 28 giorni dal basale dello studio precedente al periodo di valutazione, e il tasso di responder nei POS (Tipo I) frequenza sul periodo di valutazione. Un responder è definito come un soggetto con una riduzione ≥ 50% nella frequenza delle crisi dal periodo di riferimento dello studio precedente. Non vengono definite variabili secondarie di efficacia per i soggetti con epilessia generalizzata.
    Altre variabili di efficacia per i soggetti con epilessia focale includono la percentuale di soggetti costantemente liberi da crisi convulsive per tutti i tipi di crisi epilettiche (I + II + III) per almeno 6 mesi e almeno 12 mesi durante il Periodo di valutazione.
    Altre variabili di efficacia per i soggetti con epilessia generalizzata includono il numero di giorni di crisi generalizzate (tipo II) per 28 giorni durante il Periodo di valutazione, la percentuale di riduzione di giorni di crisi generalizzate (tipo II) per 28 giorni dal basale dello studio precedente al Periodo di valutazione, il tasso di responder di giorni di crisi generalizzate (tipo II) nel periodo di valutazione e la percentuale di soggetti che sono continuamente liberi da crisi convulsive per tutti i tipi di crisi epilettiche (I + II + III) per almeno 6 mesi e
    almeno 12 mesi durante il periodo di valutazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ongoing on a daily basis
    In corso su base giornaliera
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months59
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months61
    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 Yes
    F.1.1Number of subjects for this age range: 13
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 624
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 650
    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)
    Please see protocol.
    si prega di vedere protocollo
    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 Decision2012-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
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