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    Summary
    EudraCT Number:2009-017723-26
    Sponsor's Protocol Code Number:Y-55-52120-142
    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:2012-03-29
    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 number2009-017723-26
    A.3Full title of the trial
    A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injection in the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.
    Studio di estensione di fase III, prospettico, multicentrico, in aperto, teso a valutare la sicurezza e l'efficacia a lungo termine del trattamento ripetuto di Dysport in iniezione intramuscolo nel trattamento della spasticita' dell'arto inferiore in soggetti adulti affetti da emiparesi spastica secondaria a ictus o lesione cerebrale traumatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injection in the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.
    Studio di estensione di fase III, prospettico, multicentrico, in aperto, teso a valutare la sicurezza e l'efficacia a lungo termine del trattamento ripetuto di Dysport in iniezione intramuscolo nel trattamento della spasticita' dell'arto inferiore in soggetti adulti affetti da emiparesi spastica secondaria a ictus o lesione cerebrale traumatica
    A.4.1Sponsor's protocol code numberY-55-52120-142
    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 SponsorIPSEN PHARMA SAS
    B.1.3.4CountryFrance
    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 supportIPSEN PHARMA SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Innovation
    B.5.2Functional name of contact pointMedical Development
    B.5.3 Address:
    B.5.3.1Street Address5 Avenue du Canada
    B.5.3.2Town/ cityLes Ulis, Cedex
    B.5.3.3Post code91966
    B.5.3.4CountryFrance
    B.5.4Telephone number+ 33(0)1 60 92 94 89
    B.5.5Fax number+ 33(0)1 60 92 94 61
    B.5.6E-mailct-application@ipsen.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 Dysport for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Biopharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOTULINUM TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeTossina
    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
    Leg Spasticity
    Spasticità degli arti inferiori
    E.1.1.1Medical condition in easily understood language
    Leg Spasticity
    Spasticità degli arti inferiori
    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 SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 study objective is to assess the long term safety of Dysport in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated Treatment Cycles
    L'obiettivo primario dello studio consiste nella valutazione della sicurezza a lungo termine di Dysport somministrato a soggetti emiparetici affetti da spasticità dell'arto inferiore secondaria a ictus o a lesione cerebrale traumatica in trattamento con cicli ripetuti.
    E.2.2Secondary objectives of the trial
    The secondary study objective is the assessment of the long term efficacy including: • Muscle tone in the gastrocnemius-soleus complex (GSC) (knee extended), • Muscle tone in the soleus muscle (knee flexed), • Physician’s Global Assessment (PGA) of treatment response, • Maximal and comfortable barefoot walking speeds, • Maximal and comfortable walking speeds with shoes, • Spasticity in the GSC (knee extended), • Spasticity in the soleus muscle (knee flexed), • Step length and cadence under different conditions, • Range of active ankle dorsiflexion, • Lower limb pain, • Quality of life (QoL), • Use of walking aids
    L'obiettivo secondario dello studio è la valutazione dell'efficacia a lungo termine, che comprende: • tono muscolare del complesso gastrocnemio-soleo (GSC) (ginocchio esteso); • tono muscolare del muscolo soleo (ginocchio flesso); • valutazione globale del medico (PGA) della risposta al trattamento; • velocità massima e confortevole di deambulazione a piedi scalzi; • velocità massima e confortevole di deambulazione con scarpe; • spasticità del GSC (ginocchio esteso); • spasticità del muscolo soleo (ginocchio flesso); • lunghezza del passo e cadenza in diverse condizioni; • range di flessione dorsale attiva della caviglia; • dolore all'arto inferiore; • qualità della vita (QdL); • uso di ausili per la deambulazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who have completed the double blind study (Study 140), up to the Week 12, Week 16, Week 20 or Week 24 follow up visit, and who do not have any major protocol deviation and/or any ongoing AEs (either of which, in the opinion of the Investigator, would pose an unacceptable risk to the subjects were they to continue receiving treatment) will be eligible for the study. Additionally, an informed consent for this open label extension study will be signed
    Tutti i pazienti arruolati in questo studio in aperto devono aver concluso lo studio in doppio cieco (Studio 140) senza deviazioni importanti dal protocollo e/o non presenteranno alcun evento indesiderato (AE) in corso (uno dei due casi, secondo il giudizio dello sperimentatore, potrebbe determinare un rischio inaccettabile per i pazienti qualora continuassero a ricevere il trattamento in questa fase in aperto del programma). Inoltre i pazienti devranno aver firmato un nuovo modulo di consenso informato.
    E.4Principal exclusion criteria
    Major limitation in the passive range of motion at the affected hip, knee or ankle, as defined by: ∘ maximum passive hip flexion (knee flexed) < 30º, ∘ maximum passive knee flexion (hip flexed) < 70º, ∘ maximum passive ankle dorsiflexion (knee flexed) < 10º, ∘ maximum passive knee extension < 160º. • Previous surgery on the affected muscles and ligaments, tendons or nerve trunks of the treated lower limb. • Previous treatment with phenol and/or alcohol in the treated lower limb at any time before the study. • Cognitive impairment altering the capacity to comply with the trial according to Investigator’s judgement. • Severe neurological impairment (not associated with the stroke or brain trauma) due to an underlying neuromuscular disease or any other underlying disease or condition affecting gait (for example, Multiple Sclerosis). • Known disease of the neuromuscular junction (such as Lambert Eaton myasthenic syndrome or myasthenia gravis). • Unwillingness or inability to comply with the protocol. • Major hypoaesthesia or ataxia on the paretic side. • Known sensitivity to Botulinum toxin (BTX) or any Dysport excipients. • Infection at the injection site(s). • Current or planned treatment with any drug that interferes either directly or indirectly with neuromuscular function (for example, aminoglycosides) within the last 4 weeks prior to study treatment. • Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study. • Treatment with a new investigational drug within 4 weeks prior to enrolment into the study or scheduled treatment with such a drug during the study period. • Any medical condition (or laboratory finding), that in the opinion of the Investigator may compromise compliance with the objectives and/or procedures of this protocol or preclude the administration of BTX.
    I pazienti saranno esclusi, se si verifica una qualsiasi delle seguenti condizioni: • Limitazioni maggiori nel range passivo di movimento dell'anca, del ginocchio o della caviglia affetta, definito da:  flessione passiva massima dell'anca (ginocchio flesso) &lt; 30°;  flessione passiva massima del ginocchio (anca flessa) &lt; 70°;  flessione dorsale passiva massima della caviglia (ginocchio flesso) &lt; 10°;  estensione passiva massima del ginocchio &lt; 160°. • Intervento chirurgico pregresso ai muscoli o ai legamenti affetti, ai tendini o ai tronchi nervosi dell'arto inferiore trattato. • Trattamento pregresso con fenolo e/o alcool dell'arto inferiore trattato in qualsiasi momento prima dello studio. • Compromissione cognitiva che, secondo il giudizio dello sperimentatore, altera la capacità di attenersi al protocollo della sperimentazione. • Grave compromissione neurologica (non associata a ictus o a trauma cerebrale) secondaria a una patologia neuromuscolare sottostante o a qualsiasi altra patologia sottostante o condizione che influisce sulla deambulazione (per esempio, la sclerosi multipla). • Nota patologia delle giunzioni neuromuscolari (come la sindrome miastenica di Lambert-Eaton o la miastenia gravis). • Non volontà o incapacità di attenersi al protocollo. • Ipoestesia maggiore o atassia sul lato paretico. • Sensibilità nota alla tossina botulinica (BTX) o a qualsiasi eccipiente di Dysport. • Infezione al(i) punto(i) di iniezione. • Trattamento in corso o pianificato con qualsiasi farmaco che interferisce direttamente o indirettamente con la funzione neuromuscolare nelle ultime quattro settimane che precedono il trattamento dello studio (per esempio, gli aminoglicosidi). • Donne in gravidanza o in premenopausa, che non intendono usare misure anticoncezionali durante la durata dello studio. • Trattamento con un nuovo farmaco sperimentale nelle quattro settimane che precedono l'arruolamento nello studio o un trattamento programmato con tale farmaco durante lo studio. • Qualsiasi condizione medica (o risultato di laboratorio), che, secondo il giudizio dello sperimentatore, possa compromettere la compliance con gli obiettivi e/o le procedure di questo protocollo o precludere la somministrazione della BTX.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints: • Adverse events. • Vital signs (systolic and diastolic BP and HR) • Clinical laboratory parameters (haematology and clinical chemistry). • Presence of BTX A Abs . The antibodies will be measured in serum samples, initially by screening radioimmunoprecipitation assay (RIPA). If RIPA is positive, the result will be confirmed by a competitive RIPA confirmatory assay. Samples positive for the presence of binding antibodies in both the screening and confirmatory RIPAs, will be analysed for the presence of neutralising antibodies using the mouse protection assay (MPA). • A 12 lead ECG performed - Efficacy endpoints: In all of the following endpoints, the baseline is defined as the baseline in the double blind study. • Mean change from baseline in the muscle tone (MAS) measured in the GSC (knee extended). • Mean change from baseline in the muscle tone (MAS) measured in the soleus muscle (knee flexed). • Proportion of subjects with at least one grade reduction in the muscle tone (MAS) measured in the GSC (knee extended). • Proportion of subjects with at least one grade reduction in the muscle tone (MAS) measured in the soleus muscle (knee flexed). • Mean PGA score. • Mean change from baseline in the 10 metre comfortable WST with shoes and without walking aids: walking speed, step length and cadence. • Mean change from baseline in the 10 metre maximal WST with shoes and without walking aids: walking speed, step length and cadence. • Mean change from baseline in the 10 metre comfortable WST barefoot and without walking aids: walking speed, step length and cadence. • Mean change from baseline in the 10 metre maximal WST barefoot and without walking aids: walking speed, step length and cadence. • Mean change from baseline in spasticity (TS) measured in the GSC with the knee extended (angle of catch (Xv3), spasticity angle (X) and spasticity grade (Y)). • Mean change from baseline in spasticity (TS) measured in the soleus muscle with the knee flexed (angle of catch (Xv3), spasticity angle (X) and spasticity grade (Y)). • Mean change from baseline in the range of active ankle dorsiflexion, both with the knee flexed (90°) and with the knee extended. • Mean change from baseline in lower limb pain. • Change from baseline in the use of walking aids/orthoses. • Mean change from baseline in QoL scales. • Mean change from baseline in muscle tone (MAS) measured in each of the injected upper limb muscle groups.</
    Endpoint di sicurezza • Eventi avversi. • Segni vitali (BP sistolica e diastolica e HR) • Parametri clinici di laboratorio (ematologia e chimica clinica). • Presenza di anticorpi anti-BTX-A al giorno 1 del ciclo di trattamento 1, alla settimana 4 di ogni ciclo di trattamento e al termine dello studio o al ritiro precoce dallo studio. Gli anticorpi saranno misurati in campioni di siero, inizialmente mediante il saggio di screening di radioimmunoprecipitazione (RIPA). Se il RIPA sarà positivo, il risultato verrà confermato da un saggio RIPA competitivo, di conferma. I campioni positivi per la presenza di anticorpi sia nel saggio RIPA di screening sia di conferma, saranno analizzati per la presenza di anticorpi neutralizzanti usando il saggio MPA. • Un ECG a 12 derivazioni al giorno 1 del ciclo di trattamento 1, alla settimana 4 di ogni ciclo di trattamento e al termine dello studio o al ritiro precoce dallo studio. Endpoint di efficacia In tutti i seguenti endpoint, il basale è definito come il basale nello studio in doppio cieco. • Variazione media rispetto al basale del tono muscolare (MAS) misurato nel GSC (ginocchio esteso). • Variazione media rispetto al basale del tono muscolare (MAS) misurato nel muscolo soleo (ginocchio flesso). • Percentuale di pazienti con almeno una riduzione di un grado del tono muscolare (MAS) misurato nel GSC (ginocchio esteso). • Percentuale di pazienti con almeno una riduzione di un grado del tono muscolare (MAS) misurato nel muscolo soleo (ginocchio flesso). • Punteggio medio della PGA. • Variazione media rispetto al basale del WST confortevole di 10 m con scarpe e senza ausili per la deambulazione: velocità di deambulazione, lunghezza del passo e cadenza. • Variazione media rispetto al basale del WST massimo di 10 m con scarpe e senza ausili pert la deambulazione: velocità di deambulazione, lunghezza del passo e cadenza. • Variazione media rispetto al momento iniziale del WST confortevole di 10 m a piedi scalzi e senza deambulatori: velocità di deambulazione, lunghezza del passo e cadenza. • Variazione media rispetto al basale del WST massimo di 10 m a piedi scalzi e senza ausili per la deambulazione: velocità di deambulazione, lunghezza del passo e cadenza. • Variazione media rispetto al basale della spasticità (TS) misurata nel GSC con il ginocchio esteso (clono, Xv3; angolo di spasticità, X, e grado di spasticità, Y). • Variazione media rispetto al basale della spasticità (TS) misurata nel muscolo soleo con il ginocchio flesso (clono, Xv3; angolo di spasticità, X e grado di spasticità, Y). • Variazione media rispetto al basale del range di flessione dorsale attiva della caviglia con ginocchio flesso (90°) ed esteso. • Variazione media rispetto al basale del dolore all'arto inferiore. • Variazione media rispetto al basale dell'uso di ausili per la deambulazione/ortesi. • Variazione media rispetto al basale della scala della QoL. • Variazione media rispetto al basale del tono muscolare (MAS) misurato in ogni gruppo di muscoli iniettati dell'arto superiore.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events: throughout the study • Vital signs (systolic and diastolic BP and HR) at Day 1 of Treatment Cycle 1 and at each study visit. • Clinical laboratory parameters at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal (haematology and clinical chemistry). • Presence of BTX A Abs at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal. • A 12 lead ECG performed at Day 1 of Treatment Cycle 1, Week 4 of each Treatment Cycle and at the end of study or early withdrawal.
    -Eventi avversi: per tutta la durata dello studio. -Segni vitali (BP sistolica e diastolica e HR) al giorno 1 del ciclo di trattamento 1 e a ogni visita dello studio. -Parametri clinici di laboratorio al giorno 1 del ciclo di trattamento 1, alla settimana 4 di ogni ciclo di trattamento e al termine dello studio o al ritiro precoce dallo studio (ematologia e chimica clinica). -Presenza di anticorpi anti-BTX-A al giorno 1 del ciclo di trattamento 1, alla settimana 4 di ogni ciclo di trattamento e al termine dello studio o al ritiro precoce dallo studio. -Un ECG a 12 derivazioni al giorno 1 del ciclo di trattamento 1, alla settimana 4 di ogni ciclo di trattamento e al termine dello studio o al ritiro precoce dallo studio.
    E.5.2Secondary end point(s)
    not applicable
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicabile
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Russian Federation
    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 months10
    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 months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 191
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 157
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 348
    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)
    not applicable
    non applicabile
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-14
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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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