The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

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

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 detected in the local laboratory test
• 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

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

They can ask all interventional clinical studies:

• submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
• Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

After Marketing Authorisation in EEA or US if the study is used for the approval.

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.