Citicoline Stroke Study "Citicoline 001"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

Focal neurologic deficit >60 minutes, CT (or MRI) compatible with clinical diagnosis or acute ischemic stroke, stroke of middle cerebral arterial origin, MIH stroke scale >=5, ambulatory and functionally independent prior to stroke, Rankin scale score <=2 prior to stroke, randomized within 24 hours of onset.

Exclusion Criteria

Evidence of brain tumor or cerebral edema with subsequent effects, previous disorder that would impair neurological assessment, improvement of neurological signs and symptoms during baseline screening, preexisting medical or psychiatric conditions that might interfere with suitability or participation, patients requiring surgery.