People Hospitalized for large hemispheric infarction stroke
Protocol: STUDY00004197
Full Title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction CHARM Study: Glibenclamide for large hemispheric infarction analyzing mRS and mortality
Description
This is a Phase 3 study, which means that BIIB093 (study drug) has already been investigated in previous clinical research studies with a small number of people with large hemispheric infarction (LHI).

You will be randomly selected (like flipping a coin) to have either the study drug or a placebo. A placebo looks like a drug but has no active ingredient. The study medication will be given once through an infusion (a needle into your vein). It will be given continuously over 72 hours (3 days). You will be in this study for up to 1 year including the follow up period and you will come in or be contacted by telephone for follow up visits during that time. Study takes place at Kaleida Health Facilities in Buffalo, NY.

Technical Description

To determine if BBII093 improves functional outcome at Day 90 as measured by modified Rankin Scale (mRS ) when compared with placebo in subjects with LHI. To determine if BIIB093 improves functional outcome at Day 90 when compared with placebo in modified intent to treat populations.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18-85.
Have had a type of stroke called a large hemispheric infarction (LHI).
It is within 10 hours of onset of LHI.
Age Group: Adults
Principal Investigator: MARILOU CHING
Contact(s)
ANNEMARIE CRUMLISH
ac35@buffalo.edu
+1 716-859-7540
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.