ICTUS Study: International Citicoline Trial on Acute Stroke

Inclusion Criteria: * Male or female, \>18 years old * Patients must be treated within 24 hours of their initial stroke symptoms onset. * Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes. * Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized. * Patients must have an acute ischemic stroke referable to the middle cerebral artery territory * At inclusion, NIHSS score \> 7, with at least 2 of these points from sections 5 \& 6 (motor) * Immediately (i.e. minutes) pre-stroke, MRS \< 2 * Women of childbearing potential must have a negative pregnancy test prior to enrolment * Signed informed consent Exclusion Criteria: * Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a) * CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage * History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study * Previous disorders that may c…