E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post stroke recovery |
Recuperación post ictus |
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E.1.1.1 | Medical condition in easily understood language |
Post stroke recovery |
Recuperación tras un accidente cerebrovascular |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061256 |
E.1.2 | Term | Ischaemic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Modified Rankin Scale (mRS) after 90 days treatment |
La escala Rankin modificada (mRS) tras 90 días de tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 90 days |
Hasta 90 días de tratamiento |
|
E.5.2 | Secondary 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) |
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E.5.2.1 | Timepoint(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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 69 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If 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 |
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E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |