Glyburide Advantage in Malignant Edema and Stroke Pilot (NCT01268683) | Clinical Trial Compass
CompletedPhase 1/2
Glyburide Advantage in Malignant Edema and Stroke Pilot
United States10 participantsStarted 2011-05-26
Plain-language summary
The primary objective of this study is to assess the feasibility of enrolling, evaluating, and treating with glyburide for injection severe anterior circulation ischemic stroke participants, whether or not treated with standard of care intravenous (IV) recombinant tissue plasminogen activator (rtPA). Participants must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 -210 centimeters cubed (cm3), and time from symptom onset to start of study infusion must be ≤10 hour(hr). The secondary objectives are to assess the initial safety and tolerability, and pharmacokinetics (PK) /pharmacodynamics (PD) of glyburide in severe stroke participants, as well as to compare the clinical and magnetic resonance imaging (MRI) outcome data to benchmark data derived from published literature.
Who can participate
Age range
18 Years – 80 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.
Key Inclusion Criteria:
* A clinical diagnosis of acute ischemic stroke in the MCA or MCA/ACA territory.
* Pre-morbid mRS 0 - 1.
* A baseline DWI lesion between 82 cm3 and 210 cm3 on MRI.
* Patients treated with IV rtPA should meet established criteria for IV rtPA administration in the 0-3 and 3-4.5 hr time periods, respectively.
* The time to the start of infusion of study compound must be ≤ 10 hr after time of symptom onset
* Age ≥18 years and ≤70 years.
* Provision of written informed consent by the patient or from a legally authorized representative according to institutional guidelines and national regulations.
Key Exclusion Criteria:
* Evidence from imaging or pre-enrollment investigation of any diagnosis other than acute ischemic stroke likely to cause the presenting symptoms and signs.
* Commitment to decompressive craniectomy (DC) prior to enrollment, or follow-ing enrollment and prior to start of study compound.
* Treatment with IA rtPA or by mechanical means for clot disruption or with hypo-thermia.
* Patients unable to tolerate MRI scanning, e.g. those with pacemakers or automatic defibrillators.
* Pre-morbid mRS ≥ 2.
* Clinical signs of herniation, e.g. one or two dilated, fixed pupils; unconsciousness (i.e., ≥ 2 on item 1a on the NIHSS); loss of other brain stem reflexes attributable to herniation according to the investigator's judgment.
* CT or MRI evidence of hemorrhage or anteroseptal/pineal shift greater ≥2 mm prior to enrollment.
* Rapidly improving sym…
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
Rate of Enrollment
Timeframe: Day 1
2
Percentage of Enrolled Participants to Screened Participants
Timeframe: Day 1
3
Percentage of Participants Completing 90-Day Follow-Up
Timeframe: Day 90
4
Percentage of Dose Reductions/ Dose Suspensions
Timeframe: Up to Day 3
5
Percentage of Participants With All Four MRI Assessments Per Protocol
Timeframe: Up to Day 3
6
Number of MRI Assessments Per Participant
Timeframe: Up to Day 3
7
Percentage of Participants Requiring One or More Hypoglycemia Treatments
Timeframe: Up to Day 4
8
Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol