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    Summary
    EudraCT Number:2013-004450-21
    Sponsor's Protocol Code Number:EMR200136-570
    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:2013-12-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-004450-21
    A.3Full title of the trial
    Multicenter, open-label, 12 weeks,
    phaseIV pRospectivE randomized study aimed at evaLuating whether sc IFN beta 1a
    (Rebif®) administered In the morning may affEct the severity of Flu-like syndrome
    and patient perceived invisible symptoms in subjects with relapsing multiple sclerosis
    Studio multicentrico, in aperto, di 12 settimane, di fase IV, prospettico, randomizzato, per valutare se l’IFN beta 1a (Rebif®) somministrato per via sottocutanea al mattino può avere effetto sulla severità della sindrome simil-influenzale e sui sintomi invisibili percepiti dal paziente nei soggetti con sclerosi multipla recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study to evaluate whether the administration of Rebif ® 44 three times a week in the morning can reduce the severity of flu-like symptoms compared to administration in the evening, in patients with relapsing multiple sclerosis not yet treated.
    studio volto a valutare se la somministrazione di Rebif® 44 tre volte alla settimana al mattino può ridurre la severità dei sintomi simil-influenzali rispetto alla somministrazione alla sera, nei pazienti con sclerosi multipla recidivante non ancora trattati.
    A.3.2Name or abbreviated title of the trial where available
    RELIEF
    RELIEF
    A.4.1Sponsor's protocol code numberEMR200136-570
    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 SponsorMerck Serono S.p.A.
    B.1.3.4CountryItaly
    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 Serono S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles S.p.A.
    B.5.2Functional name of contact pointSite Monitoring
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma, 108
    B.5.3.2Town/ cityCassina de' Pecchi (MI)
    B.5.3.3Post code20060
    B.5.3.4CountryItaly
    B.5.6E-mailfabrizio.marino@quintiles.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 Rebif 44 microgrammi/0.5ml soluzione iniettabile in cartuccia
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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.3.1Product nameRebif®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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.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 multiple sclerosis
    Sclerosi multipla recidivante
    E.1.1.1Medical condition in easily understood language
    autoimmune disease of CNS
    malattia autoimmune che colpisce il Sistema Nervoso centrale
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the severity of flu like symptoms (FLS), as measured by items 13-16 of the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ), in subjects injecting Rebif® 44 tiw in the morning compared to the evening administration.
    Valutare la gravità dei sintomi simil-influenzali (FLS), misurati mediante i punti 13-16 del questionario Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ), in soggetti trattati con iniezioni di Rebif® 44 tre volte alla settimana (tiw) al mattino, in confronto con la somministrazione alla sera.
    E.2.2Secondary objectives of the trial
    •To assess the longitudinal changes in the following other items of the MSTCQ: items 17-23 for subscales injection site reaction (ISR) and Global Side-Effects, item 35 (Benefits), and items 36-38 (Short-Form McGill Pain Questionnaire, Visual Analogue Scale [VAS], and Rating of Pain) regarding injection pain at Weeks 4, 8, and 12 or ET of treatment;
    •To assess the longitudinal changes in anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS) in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    •To assess the longitudinal changes in fatigue symptoms as measured by the Fatigue Severity Scale (FSS) in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    •To assess the longitudinal changes in sleep disorders as measured by the Pittsburgh Sleep Quality Index (PSQI) in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    •Valutare le variazioni nel tempo dei seguenti altri punti del MSTCQ: punti 17-23 per le sottoscale relative alla reazione nella sede dell’iniezione (ISR) e agli effetti collaterali globali, punto 35 (Benefici), e punti 36-38 (Questionario Short-Form McGill Pain, Scala visuo-analogica [VAS], e Scala del dolore), relativamente al dolore nella sede di iniezione alle settimane 4, 8, e 12, o all’interruzione prematura (ET) del trattamento;
    •Valutare le variazioni nel tempo dei sintomi dell’ansia misurati mediante la Hospital Anxiety and Depression Scale (HADS) in soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    •Valutare le variazioni nel tempo dei sintomi della fatica. misurati mediante la Fatigue Severity Scale (FSS) in soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluate (in a subset of patients participating in the substudy) the correlation between cytokines (leptin, resistin, adiponectin) and other immunological biomarkers (IL-12, IL-10, IL-6) linked to circadian rhythms measured at baseline and week 12 with the total duration of sleep (total sleep time, TST) and REM sleep as measured by polysomnography (PSG) at the same visits, in subjects treated with injections of Rebif ® 44 tiw in the morning, in comparison with the administration to evening.
    Valutare (in un sottogruppo di pazienti che prendono parte al sottostudio) la correlazione tra le citochine (leptina, resistina, adiponectina) e altri biomarcatori immunologici (IL-12, IL-10, IL-6) legati ai ritmi circadiani misurati al basale e alla settimana 12 con la durata totale del sonno (Total Sleep time, TST) e del sonno REM, misurati mediante polisonnografia (PSG) alle stesse visite, in soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera.
    E.3Principal inclusion criteria
    1. Males and females between 18 and 60 years of age;
    2. Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study;
    3. Patients have relapsing multiple sclerosis (RMS) according to the revised McDonald Criteria (2010);
    4. Patients with an expanded disability status scale (EDSS) score < 6.0;
    5. Patients naïve to treatment and eligible for treatment with Rebif® 44 tiw, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months;
    6. Patients able to self-inject treatment using RebiSmart™;
    7. Patients willing and able to comply with the protocol for the duration of the study;
    8. Patients have given written informed consent to take part in the study.
    1. Maschi e femmine di età compresa tra 18 e 60 anni;
    2. I soggetti di sesso femminile non devono essere in gravidanza o in fase di allattamento e non devono essere potenzialmente fertili. Inoltre, i soggetti di sesso femminile non devono essere stati in gravidanza per almeno tre mesi prima dell’ingresso nello studio;
    3. Pazienti con sclerosi multipla recidivante (RMS), in base ai criteri McDonald Criteria rivisti (2010);
    4. Pazienti con un punteggio della scala EDSS < 6.0;
    5. Pazienti non precedentemente trattati e idonei al trattamento con Rebif® 44 tiw, o pazienti precedentemente trattati con glatiramer acetato che abbiano completato un wash-out di almeno tre mesi, o pazienti precedentemente trattati con natalizumab o fingolimod che abbiano completato un wash-out di almeno tre mesi;
    6. Pazienti in grado di effettuare l’auto-iniezione con RebiSmart™;
    7. Pazienti disponibili ad aderire alle procedure del protocollo per tutta la durata dello studio;
    8. Pazienti che abbiano fornito il consenso informato scritto per la partecipazione allo studio.
    E.4Principal exclusion criteria
    1. Patients have any disease other than MS that could better explain their signs and symptoms;
    2. Patients received any immunosuppressive agents within 3 months prior to Baseline;
    3. Patients received any corticosteroids within 30 days prior to baseline;
    4. Patients have a MS relapse within 30 days prior to Baseline;
    5. Patients have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase;
    6. Patients have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal (LLN);
    7. Patients have moderate to severe renal impairment;
    8. Patients have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart™;
    9. Patients have hypersensitivity to natural or recombinant interferon, or to any of its excipients;
    10. Patients have any contra-indications to treatment with IFN-beta 1a according to Summary of Product Characteristics (SmPC);
    11. Patients have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC;
    12. Obese patients, defined by BMI >30 kg/m2;
    13. Patients have participated in any other investigational trial within 30 days from Baseline;
    14. Patients have any other significant disease that in the Investigator’s opinion would exclude the subject from the trial.
    1. Pazienti con altre malattie oltre alla sclerosi multipla che possono meglio spiegare i segni e sintomi;
    2. Pazienti trattati con farmaci immunosoppressori nei 3 mesi precedenti la visita basale;
    3. Pazienti trattati con corticosteroidi nei 30 giorni precedenti la visita basale;
    4. Pazienti con recidiva della sclerosi multipla nei 30 giorni precedenti la visita basale;
    5. Pazienti con funzionalità epatica alterata, definita come un valore di alanina aminotransferasi (ALT) > 3 volte il limite superiore di normalità (3 x ULN), o fosfatasi alcalina > 2 x ULN, o di bilirubina totale > 2 x ULN se associata con qualsiasi innalzamento di ALT o fosfatasi alcalina;
    6. Pazienti con riserva di midollo osseo inadeguata, definita come conta dei globuli bianchi inferiore a 0.5 x limite inferiore di normalità (LLN);
    7. Pazienti con insufficienza renale da moderata a severa;
    8. Pazienti con qualsiasi limitazione della vista o fisica che impedisca ai soggetti di auto-iniettare il trattamento mediante il RebiSmart™;
    9. Pazienti con ipersensibilità all’interferone naturale o ricombinante, o a uno qualsiasi dei relativi eccipienti;
    10. Pazienti con qualsiasi controindicazione al trattamento con IFN-beta 1a, in base al riassunto delle caratteristiche del prodotto (SmPC);
    11. Pazienti con qualsiasi controindicazione al trattamento con ibuprofene/paracetamolo in base al SmPC;
    12. Pazienti obesi, definiti come BMI >30 kg/m2;
    13. Pazienti che hanno preso parte a qualsiasi studio sperimentale nei 30 giorni precedenti la visita basale;
    14. Pazienti con altre malattie significative che, a giudizio dello sperimentatore, precludono la partecipazione del soggetto allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in FLS score at week 12, as measured by items 13-16 of the MSTCQ, in subjects injecting Rebif® 44 tiw in the morning compared to the evening.
    Differenza nel punteggio FLS alla 12.ma settimana, misurato mediante i punti 13-16 del MSTCQ, in soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    settimana 12
    E.5.2Secondary end point(s)
    • Difference in FLS score at week 4 and 8 in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Differences at week 4, 8 and 12 in subjects injecting Rebif® 44 tiw in the morning compared to the evening in MSTCQ scores of items 17-23 for injection site reaction (ISR) and Global Side-Effects, item 35 (Benefits), and items 36-38 (Short-Form McGill Pain Questionnaire, Visual Analogue Scale [VAS], and Rating of Pain) regarding injection pain;
    • Changes from baseline to week 4, 8 and 12 in HADS score in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Changes from baseline to week 4, 8 and 12 in FSS score in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Changes from baseline to week 4, 8 and 12 in PSQI score in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Changes from baseline to week 4, 8 and 12 in MusiQoL score in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Rate of adherence in subjects injecting Rebif® 44 tiw in the morning compared to the evening at week 4, 8 and 12;
    • Changes from baseline to Week 12 in circulating levels of cytokines (i.e. leptin, resistin, adiponectine) linked to circadian rhythm;
    • Correlations between changes from baseline to Week 12 in circulating levels of cytokines and in FLS score;
    • Correlations (explorative analysis) between changes from baseline to Week 12 in circulating levels of cytokines and in other MSTCQ items, HADS, FSS, PSQI and MusiQoL score.
    Substudy:
    • Changes from baseline to Week 12 in cytokines and hormone-like cytokines levels (i.e. leptin, resistin, adiponectine, IL-12, IL-10 and IL-6 [R&D systems]) in subjects injecting Rebif® 44 tiw in the morning compared to the evening;
    • Changes from baseline to Week 12 in Total sleep time (TST) and N1, N2, N3 and REM sleep time, as measured by PSG;
    • Correlations between changes from baseline to Week 12 in cytokines and hormone-like cytokines levels, and TST, N1, N2, N3 and REM sleep time.
    • Differenza nel punteggio FLS alle settimane 4 e 8 nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Differenza alle settimane 4, 8 e 12, nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera, per i punteggi MSTCQ relativi ai punti 17-23 per le reazioni nella sede di iniezione (ISR) e gli effetti collaterali globali, al punto 35 (benefici), e ai punti 36-38 (Short-Form McGill Pain Questionnaire, Scala visuale-analogica [VAS], e scala del dolore) relativi al dolore nella sede di iniezione;
    • Variazioni dal basale alle settimane 4, 8 e 12 per il punteggio HADS nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Variazioni dal basale alle settimane 4, 8 e 12 per il punteggio FSS nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Variazioni dal basale alle settimane 4, 8 e 12 per il punteggio PSQI nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Variazioni dal basale alle settimane 4, 8 e 12 per il punteggio MusiQol nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Percentuale di pazienti con aderenza al trattamento tra i soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera alle settimane 4, 8 e 12;
    • Variazioni dal basale alla settimana 12 nei livelli circolanti di citochine (ovvero leptina, resistina, adiponectina) legate al ritmo circadiano;
    • Correlazioni tra le variazioni dal basale alla settimana 12 nei livelli circolanti di citochine e nel punteggio FLS;
    • Correlazioni (analisi esplorativa) tra le variazioni dal basale alla settimana 12 nei livelli circolanti di citochine e nei punteggi degli altri punti del MSTCQ, HADS, FSS, PSQI e MusiQoL.
    Sottostudio:
    • Variazioni dal basale alla settimana 12 nei livelli di citochine e degli ormoni simil-citochine (ovvero leptina, resistina, adiponectina, IL-12, IL-10 e IL-6 [sistemi R&D]) nei soggetti trattati con iniezioni di Rebif® 44 tiw al mattino, in confronto con la somministrazione alla sera;
    • Variazioni dal basale alla settimana 12 nella durata totale del sonno (TST) e nel tempo di sonno N1, N2, N3 e REM, misurati mediante PSG;
    • Correlazioni tra le variazioni dal basale alla settimana 12 nei livelli di citochine e degli ormoni simil-citochine, e TST, tempo di sonno N1, N2, N3 e REM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    settimana 12
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    differenti dosaggi e tempi di somministrazione
    different dosages and time for administration
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned34
    E.8.5The trial involves multiple Member States No
    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
    database loked
    chiusura database
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 218
    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 state218
    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)
    standard therapy
    terapia standard
    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 Decision2014-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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