This study evaluates the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.
This study, previously posted by Remedy Pharmaceuticals, Inc., has transitioned to Biogen with the acquisition of CIRARA.
- Placebo Drug
Intervention Desc: Administered as specified in the treatment arm. ARM 1: Kind: Experimental Label: Placebo Description: Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
- CIRARA (glyburide for injection) Drug
ARM 1: Kind: Experimental Label: CIRARA Description: CIRARA (glyburide for injection)
- Placebo (for CIRARA) Drug
ARM 1: Kind: Experimental Label: Placebo for CIRARA Description: Placebo (for CIRARA)
- BIIB093 Drug
Other Names: glibenclamide; glibenclamide intravenous (IV); glyburide; CIRARA Intervention Desc: Administered as specified in the treatment arm. ARM 1: Kind: Experimental Label: BIIB093 Description: BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Proportion of participants with improvement in functional outcome at 90 days assessed via the modified Rankin Scale||Change from baseline at 90 days||No|
|Secondary||Proportion of participants with improvement in overall survival at 90 days||Change from baseline at 90 days||No|
|Secondary||Proportion of participants with a reduction in midline shift at 72 hours assessed via non-contrast computed tomography||Change from baseline at 72 hours||No|
|Secondary||Safety of CIRARA via collection of adverse events and serious adverse events||Change from baseline through 15 days||Yes|
|Primary||Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)||Baseline up to Day 90|
|Secondary||Time to All-Cause Death||Baseline up to Day 90|
|Secondary||Proportion of Participants Who Achieved mRS 0-4 at Day 90||Baseline up to Day 90|
|Secondary||Reduction in Midline Shift at 72 Hours||Baseline up to 72 hours|
|Secondary||Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline up to Day 90|