Glyburide Advantage in Malignant Edema and Stroke Pilot "GAMES-PILOT"

Completed

Phase 1/2 Results

Summary of Purpose

The study objective is to assess the feasibility of enrolling, evaluating, and treating with RP-1127 (Glyburide for Injection) severe anterior circulation ischemic stroke patients, whether or not treated with standard of care IV rtPA. Patients must be between 18-80 years of age, must have a baseline diffusion weighted image (DWI) lesion volume 82 - 210 cm3, and time from symptom onset to start of study infusion...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 14 May 2014.

1 May 2011 29 Dec 2010 1 Jun 2012 1 Feb 2013 1 May 2014 11 Mar 2014
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Contacts

  • Kevin Sheth, MD