Citicoline in Ischemic Stroke

Inclusion Criteria:

• • Both genders aged > 18 years.
• Patients must be treated within 24 hours of their initial stroke symptoms onset.
• Patients not eligible to receive rTPA.
• Patients with a measurable focal neurological deficit (NIHSS score ≥ 8) lasting for aminimum of 60 minutes. This deficit must persist from onset and up to the time oftreatment without clinically significant improvement
• Patients must have a CT scan and/or conventional MRI compatible with the clinicaldiagnosis of acute ischemic stroke prior to being randomized.
• Patients must have an acute ischemic stroke with symptoms referrable to internalcarotid territory.
• At inclusion, NIHSS score 8-15, with at least 2 of these points from sections 5 & 6 (motor).
• Immediately (i.e. minutes) pre-stroke, mRS ≤ 1. [History of past stroke does not, byitself, preclude study entrance].
• Women of childbearing potential must have a negative pregnancy test prior toenrolment.
• Signed informed consent (following a full explanation of the nature and purpose ofthis study, the patient or legal guardian(s) or representative(s) must consent toparticipate by signing the Informed Consent document

Exclusion Criteria:

• Patients eligible for rTPA treatment.
• Patients in coma: patients having a score of 2 or higher in the items regarding thelevel of consciousness in the NIHSS (1a).
• CT or conventional MRI evidence of any structural brain disorder other than ischemicstroke.
• History of ventricular dysrhythmias, acute myocardial infarction within 72 hours priorto enrolment, unstable angina, decompensated congestive heart failure or any otheracute, severe, uncontrollable or sustained cardiovascular condition that, in theInvestigator's opinion, may interfere with effective participation in the study.
• Previous disorders that may confound the interpretation of the neurological scales.
• Drug addiction-related disorders.
• Pre-existing dementia, when dementia implies a disability, measured as an score of 2or higher in the previous mRS.
• Pre-existing medical condition that, in the Investigator's opinion, may interfere withthe patient's suitability and participation in the study.
• Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening.
• Patients under current treatment with citicoline.
• Prior (over past 3 months) or concomitant administration of other neuroprotectantdrugs (such as nimodipine, vinponcetine, piracetam, cerebrolysin,…).