Trial ID or NCT#

NCT01794182

Status

RECRUITING

Purpose

This is a randomized, multi-center, prospective, double blind study. The primary objective is to demonstrate the efficacy of RP-1127 compared to placebo in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. This objective will be addressed by comparing the proportion of RP-1127 treated patients and placebo treated patients with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC).

Official Title

A Randomized, Multi-center, Prospective, Double Blind, Phase II Trial of RP- 1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Develop Malignant Edema

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Gregory W. Albers, MD
Stroke and vascular neurologist
The Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery at the Stanford University Medical Center

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CONTACT

Stephanie Kemp
skemp@stanford.edu