E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post stroke recovery |
Recupero post-ictus |
|
E.1.1.1 | Medical condition in easily understood language |
Post stroke recovery |
Recupero post-ictus |
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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 | 22.1 |
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 |
|
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. |
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.2.2 | 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. |
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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.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 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.5.1 | Primary end point(s) |
Modified Rankin Scale (mRS) after 90 days treatment |
Scala di Rankin modificata dopo 90 giorni |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 90 days |
Fino a 90 giorni |
|
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) |
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.5.2.1 | Timepoint(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 EVENTI AVVERSI: TUTTI PER TUTTO LO STUDIO C-SSRS: G5 G30 G60 G90 G105 ESAME FISICO: ASSE G0 G5 G30 G60 G90 G105 SEGNI VITALI IN POSIZIONE SUPINA (PAD e PAS): 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 |
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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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 77 |
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 | Information not present in EudraCT |
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 |
Brazil |
Canada |
Korea, Republic of |
Russian Federation |
Belgium |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Slovenia |
Spain |
Sweden |
United Kingdom |
Czechia |
|
E.8.7 | Trial 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 |
LVLS |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |