Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals
Completed · Phase 2 · Has a placebo group
Conditions studied: Ischemic Stroke, Malignant Edema
In brief
This is a randomized, multi-center, prospective, double blind study. The primary objective is to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.This objective will be addressed by comparing the proportion of glyburide treated particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of RP-1127 compared to placebo in participants with a severe anterior circulation ischemic stroke who were likely to develop malignant edema.
Key facts
- Study ID
- NCT01794182
- Run by
- Remedy Pharmaceuticals, Inc.
- People needed
- 86
- Starts
- 2013-06-13
- Expected to finish
- 2016-04-04
- Last updated by the study team
- 2024-11-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Arizona Medical Center — Tucson, Arizona, United States
- Stanford University Medical Center — Stanford, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- University of Florida, Jacksonville — Jacksonville, Florida, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- University of Louisville Hospital — Louisville, Kentucky, United States
- Maine Medical Center — Scarborough, Maine, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- UMASS Memorial Medical Center — Worcester, Massachusetts, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Oregon Health & Science University Hospital — Portland, Oregon, United States
- Abington Memorial Hospital — Abington, Pennsylvania, United States
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Utah Healthcare — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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