Status:
COMPLETED
Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours
Lead Sponsor:
Genervon Biopharmaceuticals, LLC
Collaborating Sponsors:
University of California, Los Angeles
Huntington Hospital
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic drug tissue plasmino...
Eligibility Criteria
Inclusion
- \> 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
- 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
Key Trial Info
Start Date :
March 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01221246
Start Date
March 8 2011
End Date
July 7 2016
Last Update
August 12 2019
Active Locations (8)
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1
UCLA Stroke Center (Departments of Emergency Medicine and Neurology at the University of California, Los Angeles Medical Center)
Los Angeles, California, United States, 90095
2
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
3
Huntington Memorial Hospital Stroke Center
Pasadena, California, United States, 91105
4
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94107