Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke … (NCT01221246) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours
United States34 participantsStarted 2011-03-08
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, i…
What they're measuring
1
Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 90 days in patients treated with GM602 within 18 hours compared to treated with placebo as primary efficacy endpoint