Cerebrovascular accidents CVA stroke
Conditions
Interventions
The study treatment period is divided into 3 arms: a first one receives placebo
wheras the second arm will be given 300 mg S44819 twice daily. The third arm
will be allocated to 150 mg S44819 twice
Sponsors
Institut de Recherches Internationales Servier I.R.I.S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients aged between 18 and 80 years (both inclusive), - Acute ischemic stroke (IS) that occurred at least 48 hours (2 days) and less than 144 hours (6 days) (both inclusive) before selection. If the exact stroke onset time is unknown, by convention it will be defined as the moment the patient was seen well for the last time. Those patients can be included if the time interval between last seen well and stroke discovery is less than 12 hours, - No previous disability (neither physical nor cognitive pre-stroke impairment), - NIHSS 7-20 (both inclusive), - Patient clinically stable according to the investigator's judgement. - Inclusion done between 72 hours (3 days) and 144 hours (6 days) (both inclusive) after IS onset, - Brain MRI results available with at least DWI, T2*, FLAIR, - Brain MRI showing an acute supratentorial cortical ischemic stroke responsible for the clinical picture of the patient.
Exclusion criteria
Exclusion criteria: - Impossibility to undertake an adequate rehabilitation in a specialised centre, and / or ambulatory rehabilitation services - Stroke due to cerebral venous thrombosis, - Vascular surgery or endovascular treatment likely to be required during the next 3 months - Severe co-morbid medical conditions with a life expectancy 480ms (at least 2 ECGs out of 3 with a QTcf > 480ms),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to demonstrate the superiority of at lest one of the two doses of S44819 versus placebo on functional recovery from ischaemic stroke measured with the mRS after 90 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: - to assess the efficacy of two doses of S44819 in stroke recovery using neurological evaluations (NIHSS), activities of daily living test (BI) and cognitive performance tests (Moca, TMT) - to assess the safety and tolerability of S44819. | — |
Countries
Netherlands
Outcome results
None listed