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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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    Summary
    EudraCT Number:2016-001005-16
    Sponsor's Protocol Code Number:CL2-44819-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-26
    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 ConcernedSpain - AEMPS
    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.
    Ensayo aleatorizado de eficacia y seguridad con S44819 oral tras un accidente isquémico cerebral reciente. Estudio de fase II internacional, multicéntrico, aleatorizado, doble ciego y controlado frente a 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
    Ensayo de eficacia y seguridad con S44819 tras un accidente isquémico cerebral reciente
    A.3.2Name or abbreviated title of the trial where available
    RESTORE BRAIN study
    Estudio RESTORE BRAIN
    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.1.1Name of SponsorLaboratorios Servier S.L.
    B.1.3.4CountrySpain
    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 supportLaboratorios Servier S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Servier S.L.
    B.5.2Functional name of contact pointMaria de Quintana Barajas
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de los Madroños 33
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917489670
    B.5.5Fax number+34913003249
    B.5.6E-mailmaria.dequintanabarajas@ervier.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 nameS44819
    D.3.2Product code S44819
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INN-
    D.3.9.2Current sponsor codeS44819
    D.3.9.3Other descriptive nameS44819
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    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
    Recuperación post ictus
    E.1.1.1Medical condition in easily understood language
    Post stroke recovery
    Recuperación tras un accidente cerebrovascular
    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 19.0
    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.
    demostrar la superioridad de al menos una de las dos dosis de S44189 frente a placebo en la recuperación funcional de un ictus isquémico medida mediante la escala Rankin modificada (mRS) tras 90 días de tratamiento.
    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.
    - Evaluar la eficacia de las dos dosis de S 44189 en la recuperación del ictus utilizando pruebas de evaluación neurológica (NIHSS), de actividades de la vida diaria (BI) y de funciones cognitivas (Moca, TMT),
    - Evaluar la seguridad y tolerabilidad de S 44189
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged between 18 and 80 years (both inclusive)
    - Acute ischemic stroke that occured at least 72 hours (3 days) and less than 144 hours (6 days) (both inclusive) before inclusion.
    Pacientes de entre 18 y 80 años (ambos incluidos) con un ictus isquémico agudo ocurrido entre al menos las 72 horas (3 días) y menos de 144 horas (6 dias) (ambos incluidos) previas a la inclusión
    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 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 MRI showing an acute lesion in brain stem or cerebellum
    - Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
    - Qualifying ischemic cerebral event older than 144 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
    - Cualquier criterio de no-selección ocurrido tras la visita de selección
    -Test de embarazo positivo en orina o sangre (en mujeres en edad fértil)
    - Cualquier anomalía clínicamente significativa vista en el análisis de laboratorio que pudiera interferir con la participación en el estudio o con su evolución en el mismo
    - Insuficiencia renal grave
    -Insuficiencia hepática grave o encimas hepáticas anómalas vistas en el análisis del laboratorio
    - Ictus causado por trombosis venosa cerebral
    - Imágenes de la resonancia magnética cerebral (RMC) que muestren microangioaptía grave.
    - Imágenes de la RMC que muestren lesión aguda en el tronco cerebral o en el cerebelo
    - Imágenes cerebrales que muestren ictus hemorrágico o transformación sintomática del mismo en hemorrágico
    -Acontecimiento cerebral isquémico de mas de 144 horas de evolución en el momento de la inclusión
    - Cualquier anomalía clínicamente relevante detectada durante las pruebas realizadas que pudiera interferir con los procedimientos del estudio o con la evolución en el mismo.
    - Intervalo QTcF del ECG prolongado de forma repetida.
    - El hecho de que el paciente o su representante legal no acepten acudir a las visitas del estudio o participar en el mismo
    E.5 End points
    E.5.1Primary end point(s)
    Modified Rankin Scale (mRS) after 90 days treatment
    La escala Rankin modificada (mRS) tras 90 días de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 90 days
    Hasta 90 días de tratamiento
    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)
    - Puntuación total en la escala “National Institutes of Health Stroke Scale”(NIHSS),
    - Puntuación total en el índice de Barthel (BI),
    - Puntuación total en la escala de evaluación cognitiva de Montreal (MoCA),
    - Trail Making Test (TMT): tiempo para la parte A y tiempo para la parte B
    - Medidas de seguridad: Acontecimientos adversos, Escala Columbia – Suicide Severity Rating Scale (C-SSRS) para evaluar comportamiento o ideación de suicidio, Peso corporal, índice de Masa corporal, Constantes vitales (supino para la tensión arterial sistólica y diastólica), ECG de doce derivaciones
    y Parámetros analíticos (hematología y bioquímica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    NIHSS: 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
    - Escala “National Institutes of Health Stroke Scale”(NIHSS)/ índice de Barthel (BI): en ASSE D0 D5 D30 D60 D90 y D105
    - escala de evaluación cognitiva de Montreal (MoCA)/ Trail Making Test (TMT): en D30 y D90
    - Escala Columbia – Suicide Severity Rating Scale (C-SSRS): en D5 D30 D60 D90 y D105
    - Acontecimientos Adversos: Durante todo el estudio.
    - Examen físico: en ASSE D0 D5 D30 D60 D90 y D105
    - Constantes Vitales en posición supino (TAS/TAD): ASSE D0 D5 D30 D60 D90 D105
    - ECG de 12 derivaciones: en D0 D5 D30 D60 D90 D105
    - Peso Corporal : ASSE D30 D60 D90 D105
    - Parametros analíticos locales (Hematología+bioquímica): D0
    - Parámetros analítico centralizados (Hematología + bioquímica): D0 D30 D60 D90 D105
    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.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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Australia
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    United Kingdom
    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
    Last visit Last Participant as stated in the protocol
    La última Visita del último paciente tal y como figura en el protocolo
    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 months8
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years1
    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.1.1.1In 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.3.3.6.1Details 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)).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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.
    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 Decision2016-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
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