Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours "GMAIS"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

- > 18 years old
- Be eligible for MRI or CT scan
- Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening DWI abnormality and Screening PWI abnormality
- Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening
- Have suffered acute ischemic stroke within 18 hours
- Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke
- Patients who received tPA or FDA approved mechanical device can also enroll
- completed informed consent form

Exclusion Criteria

- Have history of stroke in the past 3 months
- Cannot be evaluated using MRI/CT
- Have stroke of the brainstem or cerebellum
- Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening
- Have hemorrhage revealed by CT or MRI scan
- Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO intensity as seen on CT
- Have blood sugar level >400 mg/DL or<50 mg/dL
- Have kidney disease, creatinine > 2.0
- Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness
- Have any prior history of seizure
- Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2)
- Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS)
- Life expectancy of less than 6 months due to comorbid conditions
- Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period
- Have participated in any other trial of an investigational agent within 90 days prior to screening
- Informed consent cannot be obtained
- Unable to participate in study visits