Glyburide Advantage in Malignant Edema and Stroke Pilot
Status:
Completed
Trial end date:
2012-06-07
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Biogen Remedy Pharmaceuticals, Inc.
Collaborators:
Massachusetts General Hospital University of Maryland University of Maryland, College Park