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    Summary
    EudraCT Number:2015-004775-78
    Sponsor's Protocol Code Number:1014802-203
    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:2021-09-06
    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 number2015-004775-78
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
    Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
    Uno studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di BIIB074 in soggetti con dolore neuropatico da radicolopatia lombosacrale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of
    BIIB074 in Subjects With Neuropathic Pain From
    Lumbosacral Radiculopathy
    Studio per valutare l'efficacia e la sicurezza di BIIB074 in pazienti con dolore neuropatico da radicolopatia lombosacrale
    A.3.2Name or abbreviated title of the trial where available
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Sa
    Uno studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli per valutare
    A.4.1Sponsor's protocol code number1014802-203
    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 SponsorCONVERGENCE PHARMACEUTICALS 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 supportConvergence Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConvergence Pharmaceuticals Ltd
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressMaia Building, Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailclinicaltrials@biogen.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 nameBIIB074
    D.3.2Product code BIIB074
    D.3.4Pharmaceutical form 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 INNRaxatrigine (proposed)
    D.3.9.1CAS number 934240-31-0
    D.3.9.2Current sponsor codeBIIB074
    D.3.9.4EV Substance CodeSUB32074
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameBIIB074
    D.3.2Product code BIIB074
    D.3.4Pharmaceutical form 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 INNRaxatrigine (proposed)
    D.3.9.1CAS number 934240-31-0
    D.3.9.2Current sponsor codeBIIB074
    D.3.9.4EV Substance CodeSUB32074
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neuropathic Pain
    From Lumbosacral Radiculopathy
    Dolore Neuropatico da Radicolopatia Lombosacrale
    E.1.1.1Medical condition in easily understood language
    Neuropathic Pain
    From Lumbosacral Radiculopathy
    Dolore Neuropatico da Radicolopatia Lombosacrale
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10050219
    E.1.2Term Lumbar radiculopathy
    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 the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.
    L'obiettivo primario dello studio è valutare l'efficacia di 2 regimi di dosaggio di BIIB074 sul dolore neuropatico in soggetti con PLSR.
    E.2.2Secondary objectives of the trial
    A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life.
    Un obiettivo secondario è valutare l'efficacia di 2 regimi di dosaggio di BIIB074 su misure di dolore neuropatico aggiuntive e valutazioni di dolore lombare, disabilità e qualità della vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    - Men and women aged 18 to 75 years inclusive
    - Has body weight =50 kg for men and =45 kg for women
    - Must have diagnosis of neuropathic PLSR
    - Has duration of neuropathic (leg) pain of at least 6 months before Screening

    Other protocol-defined inclusion/exclusion criteria may apply.
    Criteri Inclusione Principali:
    - Uomini e donne di età compresa tra 18 e 75 anni inclusi
    - Ha un peso corporeo di =50 kg per gli uomini e =45 kg per le donne
    - Deve presentare una diagnosi di PLSR neuropatico
    - Presenta dolore neuropatico (alla gamba) di durata di almeno 6 mesi prima dello screening

    Altri criteri di inclusione/esclusione definiti dal protocollo possono essere applicati.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    - Has pain of a different type in the legs (e.g. due to arthritis) that may interfere with the assessment of neuropathic pain in the legs.
    - Has planned surgical intervention for PLSR within the duration of the study.
    - Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
    - Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders
    - Unable to discontinue prior to Day 1 any prohibited concomitant monoamine oxidase inhibitors (MAOIs), potent CYP3A4 inducers or inhibitors, potent UGT inducers or inhibitors, including over the counter preparations, herbal remedies, vitamin, mineral supplements, food or drinks as detailed in 11.5.1.2
    - Is pregnant or lactating (female subjects only).
    - Male subject whose partner is pregnant
    - Has used paracetamol/acetaminophen at a daily dose of equal to or more than 2.5g/day on 5 or more days during 7 consecutive days in the run in phase.
    - Other protocol-defined inclusion/exclusion criteria may
    apply.
    Criteri di Esclusione Principali:
    - Presenta dolore di tipo diverso nelle gambe (es. dovuto ad artrite) che potrebbe interferire con la valutazione del dolore neuropatico nelle gambe.
    - Ha un intervento chirurgico programmato per PLSR entro la durata dello studio.
    - Ha un’anamnesi di neuropatia periferica (per esempio dovuta a diabete, consumo di alcol, altre cause, o idiopatica) o evidenza di neuropatia periferica, in seguito a esame neurologico.
    - Ha un’anamnesi o presenta rischio di crisi convulsive o di epilessia, danno cranico significativo dal punto di vista clinico, o malattie neurologiche correlate.
    - Non è in grado di interrompere prima del Giorno 1 i farmaci concomitanti proibiti: inibitori della monoammino ossidasi (MAOIs), potenti induttori o inibitori del CYP3A4, potenti induttori o inibitori di UGT, incluse preparazioni da banco, rimedi a base di erbe, vitamine, integratori minerali, cibi o bevande come dettagliato in 11.5.1.2.
    - È incinta o in fase di allattamento (solo per i soggetti di sesso femminile).
    - È un soggetto di sesso maschile la cui partner è incinta.
    - Ha assunto paracetamolo/acetaminofene ad una dose giornaliera uguale o superiore a 2.5 g/giorno per 5 o piu’ giorni durante 7 giorni consecutivi nella fase di run in.
    - Altri criteri di inclusione/esclusione definiti dal protocollo possono essere applicati.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS.
    Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period.
    *Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening.
    L'endpoint primario che si riferisce a questo obiettivo è la variazione dalla baseline (Settimana 2) alla Settimana 14 nella media settimanale del punteggio del dolore neuropatico* sulla scala da 11 punti PI-NRS (Scala di valutazione numerica dell'intensità del dolore PI-NRS). Ogni sera verrà chiesto ai soggetti di classificare il loro dolore neuropatico complessivo nel periodo delle ultime 24 ore.
    *Il dolore neuropatico sarà valutato nella gamba maggiormente colpita, identificata allo Screening.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14 last 24-hour period.
    Settimana 14 ultimo periodo di 24 ore
    E.5.2Secondary end point(s)
    Efficacy endpoints in neuropathic pain:
    1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a =50% reduction in the weekly average of the
    daily neuropathic pain score from Baseline (Week 2) to Week 14
    2. 30% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a =30% reduction in the weekly average of the
    daily neuropathic pain score from Baseline (Week 2) to Week 14¿
    3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit
    Efficacy endpoint in low back pain:
    4. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to
    rate their overall low back pain for the last 24-hour period
    Other efficacy endpoints:
    5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14, where a responder is defined as either "much improved" or "very much
    improved"
    6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index
    7. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality
    8.Change from Baseline (Week 2) to Week 14 in the Brief Pain Inventory (BPI)-Interference index
    9. Change from Baseline (Week 2) to Week 14 in the BPI-Pain index
    10. Change from Baseline (Week 2) to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
    11. Change from Baseline (Week 2) to Week 14 in the Short Form 36 Questionnaire (SF-36)
    12. Amount of rescue medication used (dosage/day)
    Another secondary objective is to investigate the safety and tolerability of 2 dose regimens of BIIB074.
    The endpoints that relate to this objective are as follows:
    ¿ AEs and SAEs
    ¿ Vital signs
    ¿ ECG parameters
    ¿ Laboratory safety tests
    ¿ Columbia-Suicide Severity Rating Scale (C-SSRS)
    Another secondary objective is to characterize the PK of BIIB074 in this population.
    • Endpoint di efficacia nel dolore neuropatico:
    - risposta di riduzione del 50% del dolore neuropatico giornaliero (sì/no) alla Settimana 14, in cui una risposta è definita come una diminuzione di =50% della media settimanale del punteggio del dolore neuropatico giornaliero dalla baseline (Settimana 2) alla Settimana 14
    - risposta di riduzione del 30% del dolore neuropatico giornaliero (sì/no) alla Settimana 14, in cui una risposta è definita come una diminuzione di =30% della media settimanale del punteggio del dolore neuropatico giornaliero dalla baseline (Settimana 2) alla Settimana 14
    - Variazione rispetto alla baseline (Settimana 2) della media settimanale del punteggio del dolore neuropatico giornaliero a ogni visita
    • Endpoint di efficacia relativo al dolore lombare:
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 nella media settimanale del punteggio del dolore lombare giornaliero; ogni sera verrà chiesto ai soggetti di classificare il loro dolore lombare complessivo nel periodo delle ultime 24 ore
    • Altri endpoint di efficacia:
    - Responder per il questionario Impressione globale di cambiamento da parte del paziente (sì/no) alla Settimana 14, in cui un responder è definito come o "migliorato molto" o "migliorato moltissimo"
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 del punteggio dell'Indice di Disabilità di Oswestry
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 nella media settimanale del punteggio del sonno quotidiano; ai soggetti verrà chiesto ogni mattina di valutare sulla Sleep Numerical Rating Scale (Scala di valutazione numerica del sonno) a 11 punti, a che livello il dolore alle gambe ha interferito con la qualità del sonno.
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 del punteggio dell'indice di interferenza del Brief Pain Inventory-interference index (BPI- Breve questionario di valutazione del dolore - indice di interferenza).
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 del punteggio del BPI-Pain index.
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 del punteggio del questionario EuroQoL a 5-Dimensioni a 5 Livelli relativo allo stato di salute
    - Variazione dalla baseline (Settimana 2) alla Settimana 14 del punteggio del questionario Short Form 36
    - Quantità di farmaco di salvataggio usato (dose/die)
    Un altro obiettivo secondario è valutare la sicurezza e la tollerabilità di 2 regimi di dosaggio di BIIB074
    • Eventi avversi ed eventi avversi seri
    • Funzioni vitali
    • Parametri dell'elettrocardiogramma
    • Analisi di sicurezza di laboratorio
    • Valutazione secondo la scala Columbia Suicide Severity Rating Scale
    Un altro obiettivo secondario è caratterizzare la farmacocinetica di BIIB074 in quest popolazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Points 1; 2; 6 - Week 14
    Point 3 - Changes from Baseline (Week 2) in the weekly average of the
    daily neuropathic pain score at each visit.
    Point 4-11 -Change from Baseline (Week 2) to Week 14
    Punti 1; 2; 6 - Settimana 14
    Punto 3 - cambiamenti dalla baseline (Seiìttimana 2) nella media settimanale del punteggio del dolore neuropatico giornaliero ad ogni visita.
    Punto 4 - 11 - Variazione dalla Baseline (Settimana 2) alla Settimana 14
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Georgia
    Serbia
    Austria
    Belgium
    Bulgaria
    France
    Italy
    Latvia
    Netherlands
    Romania
    Slovakia
    Spain
    United Kingdom
    Czechia
    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
    Ultima visita ultimo paziente
    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 months2
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 104
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 434
    F.4.2.2In the whole clinical trial 504
    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)
    Eligible subjects may continue into the extension study, Study 1014802-204.
    Soggetti eleggibili possono continuare nello studio di estensione, Studio 1014802-204
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-06
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