Sygen in Acute Stroke Study "SASS"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

CT compatible with anterior and middle cerebral artery ischemic stroke, at least 21 years of age, residence near study center, negative pregnancy test and reliable contraception, cooperative and willing to accept injections, virtually independent in activities of daily living before onset, informed consent.

Exclusion Criteria

Lesions interfering with neurological assessment, onset of symptoms more than 48 hours before first dose, stupor or coma, significant mass effect on computed tomogram (CT), unstable or evolving stroke, inability to perform required psychological tests (except for aphasics), concomitant neurological condition affecting evaluation, acute or unstable medical conditions, metabolic and systemic disorders, alcoholism or drug abuse, clinically significant abnormal laboratory values, lactating or pregnant women, need for disallowed medications, significant allergy.