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. - RESTORE BRAIN study

Institut de Recherches Internationales Servier0 个研究点目标入组 585 人开始时间: 2016年7月1日最近更新: 2022年1月24日

研究概览

暂无简介。

•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 145
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 435

•- 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 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
•- Absence of signed informed consent by the patient, patients unable to provide informed consent: patients with aphasia (verbal Glasgow Coma Scale (GCS) score < 5 and NIHSS score > 0 on item 9), patients with impaired consciousness (GCS < 14, Reaction Level Scale (RLS)>1, NIHSS total score = 1 on item 1

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