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

Completed · Phase 2 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01221246

Run by

Genervon Biopharmaceuticals, LLC

People needed

34

Starts

2011-03-08

Expected to finish

2016-07-07

Last updated by the study team

2019-08-12

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• 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

Where it is running

• UCLA Stroke Center (Departments of Emergency Medicine and Neurology at the University of California, Los Angeles Medical Center) — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Huntington Memorial Hospital Stroke Center — Pasadena, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• University of Louisville — Louisville, Kentucky, United States
• Columbia University Medical Center — New York, New York, United States
• University Erlanger Hospital — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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