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

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genervon Biopharmaceuticals, LLC
• Collaborators: California Pacific Medical Center Research Institute; Columbia University; Hoag Memorial Hospital Presbyterian; Huntington Hospital; Sarasota Memorial Hospital; University Hospital Erlangen; University of California, Los Angeles; University of Louisville

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 diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (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