Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals (GAMES-RP)
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|ClinicalTrials.gov Identifier: NCT01794182|
Recruitment Status : Unknown
Verified May 2015 by Remedy Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : February 18, 2013
Last Update Posted : June 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Malignant Edema||Drug: RP-1127 (Glyburide for Injection)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||April 2016|
Placebo Comparator: Matching Placebo
Subjects will receive matching placebo.
Experimental: RP-1127 (Glyburide for Injection)
Subjects will receive the active agent, RP-1127 (Glyburide for Injection)
Drug: RP-1127 (Glyburide for Injection)
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794182
|Principal Investigator:||Kevin N Sheth, MD||Yale University|
|Principal Investigator:||W. Taylor Kimberly, MD, PhD||Massachusetts General Hospital|