This study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (AIS) at risk of developing Malignant Cerebral Edema (MCE)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Intravenous Solution
Matching Intravenous Solution
CPMC Comprehensive Stroke Care Center
San Francisco, California, United States
Amount of midline shift (MLS) at 72 hours from Last Known Well (LKW)
Midline shift will be measured in millimeter on non-contrast computer tomography (NCCT)
Time frame: 72 Hours from Last Known Well
Percentage of Participants with modified Rankin Scale-Structured Interview (mRS-SI) score </= 4 vs. >4
Time frame: At Day 90
Amount of MLS
MLS will be measured in millimeter on NCCT
Time frame: At 48 hours and 96-120 hours from LKW
Percentage of Participants with Surgical DHC Performed
Time frame: From Baseline up to Day 90
Percentage of Participants Who Received Hyperosmolar therapy following initiation of study treatment
Time frame: From Baseline up to Day 90
National Institute of Health Stroke Scale (NIHSS) score
Time frame: At Day 4 and Day 90
Mortality
Mortality in the first 30 days after the enrollment
Time frame: At Day 30
mRS-SI score
Time frame: At Day 30
Functional Independence Measure (FIM) score
Time frame: At Discharge or Day 10 and Day 90
Glasgow Outcome Scale Extended (GOSE) Score
Time frame: at Discharge or Day 10, Day 30 and Day 90
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Stroke Impact Scale-16 (SIS-16) score
Time frame: At Day 30 and Day 90
Length (in days) of ICU and Hospital Stay
Time frame: From Baseline to Day 90
Number of participants with adverse events and severity of adverse events
Severity will be determined according to the NCI CTCAE v5.0
Time frame: From Baseline to Day 90
Plasma concentrations of balovaptan at specified timepoints
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)
Area under the concentration-time curve from Time 0 to 24 hours after a given dose (AUC24hr)
As calculated by NCA from measured concentration
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Maximum observed concentration (Cmax)
As calculated by NCA or taken directly from measured concentration
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Plasma drug concentration 24hours after the administration of a given dose (C24hr)
As calculated by NCA or taken directly from measured concentration
Time frame: From Baseline to 120 Hours After the End of the Last Infusion (or at discharge)]
Number of participants with safety findings on brain imaging
Time frame: From Baseline to Day 90