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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43886   clinical trials with a EudraCT protocol, of which   7296   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2016-001005-16
    Sponsor's Protocol Code Number:CL2-44819-004
    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:2021-06-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001005-16
    A.3Full title of the trial
    Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event. International, multi-centre, randomized, double-blind placebo-controlled phase II study.
    Studio randomizzato sulla sicurezza e l'efficacia di S 44819 per somministrazione orale dopo un evento cerebrale ischemico recente. Studio di fase II, internazionale, multicentrico, randomizzato, in doppio cieco controllato con placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety trial with S 44819 after recent ischemic cerebral event
    Studio di efficacia e sicurezza con S 44819 dopo un evento ischemico cerebrale recente
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCL2-44819-004
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-8991
    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.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 supportADIR
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerca Servier
    B.5.2Functional name of contact pointProject Manager Eleonora GRIPPA
    B.5.3 Address:
    B.5.3.1Street AddressVIA LUCA PASSI 85
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00166
    B.5.4Telephone number06669081
    B.5.5Fax number0666908738
    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 nameS44819
    D.3.2Product code [S44819]
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeS44819
    D.3.9.4EV Substance CodeSUB128536
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 placeboPowder for oral suspension
    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
    Post stroke recovery
    Recupero post-ictus
    E.1.1.1Medical condition in easily understood language
    Post stroke recovery
    Recupero post-ictus
    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 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    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 demonstrate the superiority of at least one of the two doses of S 44819 versus placebo on functional recovery from ischemic stroke measured with the modified Rankin Scale (mRS) after 90 days of treatment.
    Dimostrare la superiorità di almeno una delle due dosi di S 44819 rispetto al placebo nel recupero funzionale da ictus ischemico, misurata con la scala di Rankin modificata (mRS) dopo 90 giorni di terapia
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of the two doses of S 44819 versus placebo in stroke recovery using neurological evaluation (NIHSS), activities of daily living test (BI) and cognitive performance tests (Moca, TMT)
    - To assess the safety and tolerability of S 44819.
    Valutare l'efficacia delle due dosi di S 44819 nel recupero dall'ictus utilizzando i test di valutazione neurologica (scala NIHSS), il test delle attività della vita quotidiana (BI) ed i test della performance cognitiva (MoCA, TMT)
    Valutare la sicurezza e la tollerabilità di S 44819
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged between 18 and 85 years (both inclusive)
    - Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion
    - Pazienti di 18-85 anni di età (estremi compresi), con ictus ischemico occorso tra le 72 ore (3 giorni) e le 192 ore (8 giorni) (estremi compresi) prima dell’inclusione
    E.4Principal exclusion criteria
    - Any non-selection criteria, which could have occurred after the selection visit
    - Positive urinary or blood pregnancy test (for female patients of child bearing potential)
    - Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome
    - Severe renal impairment
    - Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test
    - Stroke due to cerebral venous thrombosis
    - Brain MRI showing a severe microangiopathy
    - Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
    - Qualifying ischemic cerebral event older than 192 hours at inclusion
    - Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome
    - Repeated prolongation of ECG QTcF
    - Patient or authorised representative refusing to attend study visits or to take part in the study
    - Eventuali criteri di non selezione che potrebbero essersi verificati dopo la visita di selezione.
    - Esito positivo del test di gravidanza mediante analisi delle urine o del sangue (per le pazienti di sesso femminile in età fertile).
    - Anomalie clinicamente significative alle analisi eseguite dal laboratorio che possono interferire con la possibilità di partecipare allo studio e/o con l’esito dello studio.
    - Insufficienza renale grave
    - insufficienza epatica grave o anomalie degli enzimi epatici riscontrate nelle analisi eseguite dal laboratorio locale
    - Ictus dovuto a trombosi venosa cerebrale.
    - RMN cerebrale che mostra microangiopatia grave
    - Imaging cerebrale che mostra emorragia cerebrale come per esempio un ictus emorragico acuto, emorragia subaracnoide, ematoma subdurale etc o una trasformazione emorragica sintomatica dell’infarto cerebrale
    - Evento ischemico cerebrale qualificante avvenuto più di 192 ore dall’inclusione.
    - Qualsiasi anomalia clinicamente rilevante individuata durante gli esami suscettibile di interferire con le procedure di studio o l’esito dello studio.
    - Prolungamento ripetuto del QTcF all’ECG
    - Paziente o rappresentante legale che si rifiuta di presenziare alle visite dello studio o di partecipare allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Modified Rankin Scale (mRS) after 90 days treatment
    Scala di Rankin modificata dopo 90 giorni
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 90 days
    Fino a 90 giorni
    E.5.2Secondary end point(s)
    - National Institutes of Health Stroke Scale (NIHSS) total score
    - Barthel Index (BI) total score
    - Montreal Cognitive Assessment scale (Moca) total score
    - Trail Making Test (TMT) time for part A and time for part B
    - Safety criteria: adverse events, suicidal ideation and suicidal behaviour using the C-SSRS, body weight, BMI, vital signs (supine for Systolic and Diastolic Blood Pressure), 12 lead-ECG, laboratory parameters (haematology and biochemistry)
    Criteri di efficacia secondari
    - Punteggio totale della National Institute of Health Stroke Scale (NIHSS)
    - Punteggio totale dell’indice di Barthel (BI).
    - Punteggio totale della scala del Montreal Cognitive Assessment (MoCA).
    - Tempo impiegato per la parte A e tempo impiegato per la parte B del Trail Making Test (TMT).

    Criteri di sicurezza secondari
    - Eventi avversi;
    - ideazione suicidaria e comportamento suicidario mediante C-SSRS
    - peso corporeo, IMC;
    - parametri vitali (pressione arteriosa sistolica e diastolica misurata con il paziente in posizione supina);
    - ECG a 12 derivazioni;
    - parametri di laboratorio (profilo ematologico e biochimico).
    E.5.2.1Timepoint(s) of evaluation of this end point
    NIHSS: ASSE D0 D5 D30 D60 D90 D105
    BI: D30 D60 D90 D105
    Moca/TMT: D30 D90
    Adverse events: all over the study
    C-SSRS: D5 D30 D60 D90 D105
    Physical examination: ASSE D0 D5 D30 D60 D90 D105
    Supine vital signs (SBP/DBP): ASSE D0 D5 D30 D60 D90 D105
    12-lead ECG: D0 D5 D30 D60 D90 D105
    Body weight: ASSE D30 D60 D90 D105
    Local biochemistry + haematology : D0
    Central biochemistry + haematology: D0 D30 D60 D90 D105
    NIHSS: ASSE G0 G5 G30 G60 G90 G105
    BI: G30 G60 G90 G105
    Moca/TMT: G30 G90
    C-SSRS: G5 G30 G60 G90 G105
    ESAME FISICO: ASSE G0 G5 G30 G60 G90 G105
    ECG 12-derivazioni: G0 G5 G30 G60 G90 G105
    PESO CORPOREO: ASSE G30 G60 G90 G105
    Biochimica ed Ematologia locale: G0
    Biochimica ed Ematologia CENTRALE: G0 G30 G60 G90 G105
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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. 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Korea, Republic of
    Russian Federation
    United Kingdom
    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
    Last visit Last Participant as stated in the protocol
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In 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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 435
    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 Yes
    F. of subjects incapable of giving consent
    Participants who can be enrolled in the study with the consent of an authorised representative according to local regulations, (participants unable to well understand the study nature or to sign as a consequence of his/her disease (aphasia)). In Ital
    Il protocollo prevede la partecipazione di soggetti incapaci di dare il proprio consenso come conseguenza della malattia stessa (afasia) in accordo alle norme locali. In Italia questa tipologia di soggetti non parteciperanno allo studio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 458
    F.4.2.2In the whole clinical trial 580
    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)
    After the discontinuation of the IMP, the participant will be provided with appropriate medical care by his physician. S 44819 is not yet licensed nor available for use other than for research purposes. The IMP will only be dispensed during the study.
    Specific rules may be followed in some countries according to local regulations.
    Dopo la sospensione dell’IMP il partecipante sarà appropriatamente seguito dal suo medico. S 44819 non ha ancora un’autorizzazione all’immissione in commercio ne è disponibile al di fuori di un uso sperimentale. L’IMP sarà dispensato solamente durante lo studio e regole specifiche potrebbero essere seguite in alcuni paesi in accordo con la legislazione locale
    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 Decision2017-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-10
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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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