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    Summary
    EudraCT Number:2018-002747-29
    Sponsor's Protocol Code Number:BIA-2093-213
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-22
    Trial 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 number2018-002747-29
    A.3Full title of the trial
    Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate
    Prevención de la epilepsia en pacientes que han sufrido un ictus y presentan un alto riesgo de desarrollar crisis no provocadas: efectos antiepileptogénicos del acetato de eslicarbazepina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic treatment of stroke patients with eslicarbazepine acetate to prevent the development of epilepsy
    Tratamiento profiláctico en pacientes que han sufrido ictus con acetato de eslicarbazepina para prevenir el desarrollo de epilepsia
    A.4.1Sponsor's protocol code numberBIA-2093-213
    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 SponsorBial - Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 supportBial - Portela & Ca, S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial - Portela & Ca, S.A.
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number0035122 98661 00
    B.5.5Fax number0035122 98661 92
    B.5.6E-mailinfo@bial.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 nameEslicarbazepine Acetate
    D.3.2Product code BIA 2-093
    D.3.4Pharmaceutical form 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 INNESLICARBAZEPINE ACETATE
    D.3.9.1CAS number 236395-14-5
    D.3.9.2Current sponsor codeBIA 2-093
    D.3.9.3Other descriptive nameESLICARBAZEPINE ACETATE
    D.3.9.4EV Substance CodeSUB30424
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 placeboTablet
    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
    Adult patients at high-risk to develop post-stroke epilepsy
    Pacientes adultos con alto riesgo de desarrollar epilepsia post-ictus
    E.1.1.1Medical condition in easily understood language
    Adult patients at high-risk to develop post-stroke epilepsy
    Pacientes adultos con alto riesgo de desarrollar epilepsia 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10076982
    E.1.2Term Post stroke epilepsy
    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 assess if eslicarbazepine acetate (ESL) treatment (started within 96 hours after stroke occurrence and continued for 30 days) changes the incidence of unprovoked seizures (USs) within the first 6 months after randomisation as compared to placebo.
    Evaluar si el tratamiento con acetato de eslicarbazepina (ESL) (iniciado en un plazo de 96 horas tras un ictus e ininterrumpido durante 30 días) cambia la incidencia de las crisis epilépticas no provocadas (unprovoked seizures, USs) durante los 6 primeros meses después de la aleatorización en comparación con el placebo.
    E.2.2Secondary objectives of the trial
    To assess if ESL treatment (started within 96 hours after stroke occurrence and continued for 30 days) 1. changes the incidence of USs within the first 12 months after randomisation as compared to placebo 2. changes the incidence of USs during the course of the trial - until 18 months after randomisation as compared to placebo
    3.To assess the number of acute symptomatic seizures 4.Time to first US after randomisation 5.Time to first US after stroke occurrence 6.Number and 4-week rate of USs 7.Functional outcome, assessed by Barthel Index original 10-item version 8.Functional outcome, assessed by National Institutes of Health Stroke Scale 9.Post-stroke depression, assessed by Patient Health Questionnaire 10.Overall survival 11.Treatment emergent adverse events incl. findings from physical and neurological examinations 12.Laboratory parameters 13.Vital signs 14.Electrocardiogram 15. Suicidal ideation and behaviour, assessed by PHQ-9
    1.Evaluar si el tratamiento con ESL (iniciado en un plazo de 96 horas tras un ictus e ininterrumpido durante 30 días) cambia la incidencia de las USs durante los 12 primeros meses después de la aleatorización en comparación con el placebo. 2.Evaluar si el tratamiento con ESL (iniciado en un plazo de 96 horas tras un ictus e ininterrumpido durante 30 días) cambia la incidencia de las USs durante todo el ensayo, hasta 18 meses después de la aleatorización en comparación con el placebo. 3.Evaluar el número de crisis epilépticas sintomáticas agudas (acute symptomatic seizures, ASs).Evaluar el efecto del tratamiento con ESL durante el periodo de seguimiento de 18 meses en lo que respecta al: 4.Tiempo hasta la primera US tras la aleatorización. 5.Tiempo hasta la primera US tras un ictus. 6.Número y frecuencia a las 4 semanas de las CENP.

    Referir al documento "Resumen Protocolo" para texto completo en español.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet ALL of the following criteria:
    1. Male or female patient aged 18 years or above.
    2. Acute intracerebral haemorrhage with a CAVE score ≥ 3 or acute ischaemic stroke with a SeLECT score ≥ 6, in each case confirmed by magnetic resonance imaging (MRI)/computed tomography (CT).
    3. Time of stroke occurrence is known and V1b is planned within 96 hours.
    4. Brain scan analysis has reliably excluded structural brain lesions that can mimic stroke, e.g. cerebral tumour or brain abscess, etc.
    5. a. Patient is able to give informed consent and to write and has signed written informed consent OR
    b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent OR
    c. Patient is unable to give informed consent, but likely to regain this ability until V2, and the informed consent is deferred OR
    d. Patient is unable to give informed consent, but likely to regain this ability until V2, and patient’s legal representative (according to the respective national/local requirements) has provided written informed consent.
    6. Female patients without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female patients with childbearing potential must not be pregnant as confirmed by a negative pregnancy test and sexually active females must use a medically acceptable effective non-hormonal method of contraception up to the end of the current menstrual cycle after stopping treatment. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, double-barrier methods, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised male partner, provided that he is the sole partner of that patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    The requirements of the relevant ethics committees must be adhered to at all times. Written or verbal witnessed informed consent from the patient must be obtained until V2.
    Inclusion criteria at V1b
    7. V1b is within 96 hours after stroke occurrence.
    Inclusion criteria at V2 (only applicable for patients who were unable to give informed consent at V1a.)
    8. a. Patient is able to give informed consent and to write and has signed a written informed consent OR
    b. Patient is able to give informed consent, but unable to write and has provided verbal witnessed consent.
    1.Hombres o mujeres de 18 o más años de edad.
    2.Hemorragia intracerebral aguda con puntuación en la escala CAVE ≥ 3 o ictus isquémico agudo con puntuación en la escala SeLECT ≥ 6, en cada caso verificado por resonancia magnética nuclear (RMN)/tomografía axial computerizada (TAC).
    3.Se conoce la hora en la que se produjo el ictus y la visita V1b se organiza en un plazo de 96 horas.
    4.La gammagrafía cerebral ha excluido con fiabilidad lesiones cerebrales estructurales que pueden imitar los síntomas de un ictus, p. ej. tumor cerebral o absceso cerebral, etc.
    5.a. El paciente puede escribir y es capaz de dar su consentimiento informado, y ha firmado un consentimiento informado por escrito, O
    b.el paciente es capaz de dar su consentimiento informado pero no puede escribir, y ha dado su consentimiento oral frente a un testigo, O
    c.el paciente no es capaz de dar su consentimiento informado, pero es posible que recupere esta capacidad antes de la visita V2, por lo que se aplaza el consentimiento informado, O
    d.el paciente no es capaz de dar su consentimiento informado, pero es posible que recupere esta capacidad antes de la visita V2, y su representante legal (conforme a los correspondientes requisitos nacionales/locales) ha dado consentimiento informado por escrito.
    6.Las pacientes sin posibilidad de quedar embarazadas (2 años después de la menopausia, ooforectomía bilateral o ligadura de trompas, o histerectomía completa) pueden participar. Las pacientes con posibilidad de quedar embarazadas no deben estar embarazadas, lo que debe confirmarse con una prueba de embarazo negativa, y las mujeres sexualmente activas deben utilizar un método anticonceptivo eficaz no hormonal que sea aceptable desde el punto de vista médico hasta que finalice su actual ciclo menstrual después de suspender el tratamiento. Entre los métodos aceptables para mujeres figuran las intervenciones quirúrgicas (p. ej. oclusión de las trompas), dispositivo intrauterino, métodos de barrera doble, verdadera abstinencia sexual (es decir, cuando esto se adapta al estilo de vida habitual y preferido de la paciente) y pareja masculina vasectomizada, siempre que esta sea la única pareja de la paciente. La abstinencia periódica (p. ej. métodos del calendario, la ovulación, sintotérmico, posovulatorio) y el coito interrumpido no son métodos anticonceptivos aceptables.
    Se deben cumplir en todo momento los requisitos de los relevantes comités de ética. Antes de la visita V2 se debe obtener el consentimiento informado del paciente oralmente o por escrito ante testigos.
    Criterios de inclusión en la visita V1b
    7.La visita V1b tiene lugar en un plazo de 96 horas desde el ictus.
    Criterios de inclusión en la visita V2 (solo procede para los pacientes que fueron incapaces de dar su consentimiento informado en visita V1a.)
    8. a. El paciente es capaz de escribir y dar su consentimiento informado, y ha firmado un consentimiento informado por escrito, O
    b. el paciente es capaz de dar su consentimiento informado pero no puede escribir, y ha dado su consentimiento oral frente a un testigo.
    E.4Principal exclusion criteria
    Patients are to be excluded from the trial for ANY ONE of the following reasons:
    1. Contraindication to ESL, i.e. known hypersensitivity to ingredients of ESL formulation or other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine), or second or third degree atrioventricular (AV) block not corrected with a permanent pacemaker.
    2. Known Han Chinese or Thai ancestry.
    3. History of previous stroke (other than the one described in inclusion criteria no. 2 - 3).
    4. Sinus venous thrombosis.
    5. Spontaneous sub-arachnoid haemorrhage due to e.g. aneurysmatic or arteriovenous malformation.
    6. History of USs prior to primary stroke.
    7. Impaired pre-stroke level of function, i.e. modified Rankin Scale (mRS) score > 3 prior to first stroke occurrence.
    8. History of AED use before primary stroke within the last 5 years as defined in the list of not allowed AEDs.
    9. Use of ESL, unless provided as IMP of this trial, and oxcarbazepine.
    10. Severe hepatic impairment.
    11. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1a).
    12. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
    13. History of suicidal ideation or suicide attempt within the past 3 years.
    14. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the trial treatment or may jeopardise the patient’s safety, compliance or adherence to protocol requirements, such as significant psychiatric, cardiovascular, respiratory, metabolic, endocrine, haematologic, infectious or neurological disease.
    15. For women: Pregnancy or breast-feeding.
    16. Previous enrolment in this trial or participation in any other investigational drug trial within the past 30 days (or 5 half-lives of IMP whichever is longer) prior to V1a.
    17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    18. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the investigator.
    Se excluirá a pacientes del ensayo por CUALQUIERA de los siguientes motivos:
    1.Contraindicaciones del ESL, es decir, hipersensibilidad conocida a los ingredientes de la formulación del ESL u otros derivados de la carboxamida (p.ej., oxcarbazepina, carbamazepina), o bloqueo auricoventricular (AV) de segundo o tercer grado que no se haya rectificado con un marcapasos permanente.
    2.Ascendencia conocida tailandesa o de etnia Han china.
    3.Antecedentes de ictus (distinto al descrito en los criterios de inclusión n.º 2 - 3).
    4.Trombosis del seno venoso.
    5.Hemorragia subaracnoidea espontánea debida, por ejemplo, a una malformación arteriovenosa o aneurismática.
    6.Antecedentes de USs antes del ictus primario.
    7.Nivel funcional alterado antes del ictus, es decir, puntuación en la escala Rankin modificada (mRS) > 3 antes del primer episodio de ictus.
    8.Antecedentes de uso de antiepilépticos antes del ictus primario durante los últimos 5 años, según se define en la lista de antiepilépticos no permitidos.
    9.Uso de ESL, excepto el facilitado como IMP de este ensayo, y oxcarbazepina.
    10.Alteración hepática grave.
    11.Tasa de filtración glomerular estimada (eGFR) < 30 ml/min/1,73 m2 (comprobada en la visita V1a).
    12.Alcoholismo crónico o agudo conocido o sospechado, delirium tremens, o psicósis tóxica.
    13.Antecedentes de ideas suicidas o intento de suicidio durante los 3 últimos años.
    14.Presencia de cualquier otra enfermedad significativa o progresiva/inestable que, en opinión del investigador, alteraría la evaluación del tratamiento del ensayo o podría afectar a la seguridad, el cumplimiento o el seguimiento de los requisitos del protocolo del paciente, como enfermedades psiquiátricas, cardiovasculares, respiratorias, metabólicas, endocrinas, hematológicas, infecciosas o neurológicas de consideración.
    15.Para mujeres: embarazo o lactancia materna.
    16.Participación previa en este ensayo o participación en cualquier otro ensayo de un medicamento en investigación durante los últimos 30 días (o 5 semividas del IMP, lo que sea más largo) antes de la visita V1a.
    17.Personas internadas en una institución por orden judicial o de cualquier otra autoridad.
    18.Empleados del centro del investigador o del ensayo, con relación directa con el ensayo propuesto o cualquier otro estudio bajo la dirección de ese investigador o centro del ensayo, además de los familiares de los empleados o del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who experience the first US within the first 6 months after randomisation (failure rate). Deaths before the first US or patients without evaluable assessment of the primary endpoint will be counted as treatment failures.
    Proporción de pacientes que sufren la primera US durante un plazo de 6 meses después de la aleatorización (tasa de fracaso). Las muertes antes de la primera CENP o los pacientes sin evaluación medible del criterio de valoración primario se contabilizarán como fracasos terapéuticos
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomisation
    6 meses después de la aleatorización
    E.5.2Secondary end point(s)
    1.Proportion of patients who experience the first US during the first 12 months after randomisation (12 months failure rate)
    2.Proportion of patients who experience the first US during the course of the trial – until 18 months after randomisation (18 months failure rate)
    3.Number of ASs
    4.Time to first US after randomisation
    5.Time to first US after stroke occurrence
    6. Number and 4-week rate of US
    7. BI
    8. NIHSS
    9. PHQ-9
    10. Overall survival
    Safety endpoints:
    11. TEAEs incl. findings from physical and neurological examinations
    12. Laboratory parameters (haematology, biochemistry, including eGFR and coagulation, and urinalysis)
    13. Vital signs
    14. ECG
    15. Suicidal ideation and behaviour (as per PHQ-9, question 9)
    Exploratory endpoint:
    16. EEG, optional
    1.Proporción de pacientes que sufren la primera US durante un plazo de 12 meses después de la aleatorización (tasa de fracaso a 12 meses).
    2.Proporción de pacientes que sufren la primera US durante el ensayo y hasta 18 meses después de la aleatorización (tasa de fracaso a 18 meses).
    3.Numero de ASs.
    4.Tiempo hasta la primera US tras la aleatorización.
    5.Tiempo hasta la primera US tras un ictus.
    6.Número y tasa a las 4 semanas de CENP.
    7.IB
    8.NIHSS
    9.PHQ-9
    10.Supervivencia general
    De seguridad:
    11.Acontecimientos adversos durante el tratamiento (treatment emergent adverse events, TEAEs), incluidos los resultados de las exploraciones físicas y neurológicas.
    12.Parámetros de laboratorio.
    13.Constantes vitales.
    14.Electrocardiograma (ECG).
    15.Ideas y conductas suicidas, evaluadas según el PHQ-9 (pregunta 9).
    Exploratorios:
    16.Electroencefalograma (EEG), opcional
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 12 months after randomisation (12 months failure rate)
    2. 18 months after randomisation (18 months failure rate)
    3. during the first 7 days after stroke
    4. to 16 up to 18 months after randomisation
    1.12 meses después de la aleatorización (tasa de fracaso a 12 meses)
    2.18 meses después de la aleatorización (tasa de fracaso a 18 meses)
    3.durante los primeros 7 días tras un ictus
    4.de 16 hasta 18 meses después de la aleatorización
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Austria
    France
    Germany
    Israel
    Italy
    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 of the last subject (LVLS)
    última visita del último paciente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Patients with acute intracerebral haemorrhage with a CAVE score ≥ 3 or acute ischaemic stroke with a SeLECT score ≥6
    - Patients unable to give informed consent at the time of inclusion into the trial, but likely to regain this ability until V2
    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 180
    F.4.2.2In the whole clinical trial 220
    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)
    None
    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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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