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 range
18 Years – 90 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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