Clinical Trial: Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: Remedy Pharmaceuticals, Inc.

Current Primary Outcome:

  • The proportion of patients with a modified Rankin Scale (mRS) at Day 90 ≤ 4 without decompressive craniectomy [ Time Frame: 90 Days ]
  • Safety of RP-1127 in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. [ Time Frame: 90 Days ]
    Addressed by comparing the frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)in the RP-1127 and placebo groups, with a specific focus on all cause mortality, cardiac mortality, and cardiac-related and blood glucose-related AEs/SAEs.


Original Primary Outcome:

  • The proportion of patients with a modified Rankin Scale (mRS) at Day 90 ≤ 4 without the need for decompressive craniectomy [ Time Frame: 90 Days ]
  • Safety of RP-1127 in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema. [ Time Frame: 90 Days ]
    Addressed by comparing the frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)in the RP-1127 and placebo groups, with a specific focus on all cause mortality, cardiac mortality, and cardiac-related and blood glucose-related AEs/SAEs.


Current Secondary Outcome:

  • Proportion of subjects undergoing DC or dead within 14 days [ Time Frame: 14 days ]
  • The change between baseline and 72-96 hours in ipsilateral hemispheric swelling measured by MRI [ Time Frame: 96 hours ]
  • The change between baseline and 72-96 hours in lesional swelling measured by MRI [ Time Frame: 96 hours ]


Original Secondary Outcome:

  • Proportion of subjects that develop malignant edema [ Time Frame: 7 days ]
  • Proportion of subjects undergoing DC, and DC-associated AEs and SAEs [ Time Frame: 90 Days ]
  • Proportion of subjects that experience early neurological deterioration [ Time Frame: 72 Hours ]
  • Proportion of subjects that develop parenchymal hematomas [ Time Frame: 7 Days ]
  • Ipsilateral hemispheric swelling measured by MRI [ Time Frame: 96 hours ]
  • Proportion of subjects with 90 day mRS 0-3 and 0-4 [ Time Frame: 90 Day ]
  • Activities of Daily Living (as measured by the Barthel Index) at 90 days [ Time Frame: 90 Days ]
  • All-cause mortality at 90 days [ Time Frame: 90 Days ]


Information By: Remedy Pharmaceuticals, Inc.

Dates:
Date Received: February 14, 2013
Date Started: May 2013
Date Completion: April 2016
Last Updated: May 31, 2015
Last Verified: May 2015