Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals "GAMES-RP"

Active, not recruiting

Phase 2 Results N/A

Trial Description

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).

Detailed Description

The study population consists of subjects with a clinical diagnosis of acute severe anterior circulation ischemic stroke, a baseline diffusion weighted image (DWI) lesion between 82 and 300 cm3, age 18-80 years, and time from symptom onset to start of study infusion of ≤10 hours. The study will enroll both patients that do not receive IV rtPA and those that receive IV rtPA within 4.5 hours of stroke.
Enrollment will be randomized controlling for site, age ≤60 (yes/no), and IV rtPA treatment at baseline (yes/no). Subjects will be randomized equally between RP-1127 and placebo.

Conditions

Interventions

  • RP-1127 (Glyburide for injection) Drug
    Other Names: glibenclamide; glybenclamide
    Intervention Desc: Glyburide (5-chloro-N-(4-[N-(cyclohexylcarbamoyl) sulfamoyl]phenethyl)-2- methoxybenzamide) is an anti-diabetic medication in a class of medications known as sulfonylureas. RP-1127 is a formulation of glyburide designed for intravenous administration.
    ARM 1: Kind: Experimental
    Label: RP-1127 (Glyburide for Injection)
    Description: Subjects will receive the active agent, RP-1127 (Glyburide for Injection)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The proportion of patients with a modified Rankin Scale (mRS) at Day 90 ≤ 4 without the need for decompressive craniectomy 90 Days No
Primary Safety of RP-1127 in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. 90 Days Yes
Secondary Proportion of subjects that develop malignant edema 7 days No
Secondary Proportion of subjects undergoing DC, and DC-associated AEs and SAEs 90 Days Yes
Secondary Proportion of subjects that experience early neurological deterioration 72 Hours No
Secondary Proportion of subjects that develop parenchymal hematomas 7 Days No
Secondary Ipsilateral hemispheric swelling measured by MRI 96 Hours No
Secondary Proportion of subjects with 90 day mRS 0-3 and 0-4 90 Day No
Secondary Activities of Daily Living (as measured by the Barthel Index) at 90 days 90 Days No
Secondary All-cause mortality at 90 days 90 Days Yes
Primary The proportion of patients with a modified Rankin Scale (mRS) at Day 90 ≤ 4 without decompressive craniectomy 90 Days No
Secondary Proportion of subjects undergoing DC or dead within 14 days 14 days No
Secondary The change between baseline and 72-96 hours in ipsilateral hemispheric swelling measured by MRI 96 hours No
Secondary The change between baseline and 72-96 hours in lesional swelling measured by MRI 96 hours No

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