The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging \[MRI\] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).
Time frame: Baseline up to 96 hours (Day 4)
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180
The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery.
Time frame: Day 180
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90
The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.
Time frame: Day 90
Percentage of Participants Requiring Delayed Intubation
Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury.
Time frame: Day 1 (24 hours) up to Day 4 (96 hours) post-injury
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Barrow Neurological Institute
Phoenix, Arizona, United States
Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
WellStar Medical Group Neurosurgery
Marietta, Georgia, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
...and 53 more locations
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging
Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT.
Time frame: Baseline up to 24 hours (Day 1)
Change From Baseline in Absolute Hematoma Volume at 24 Hours
Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO.
Time frame: Baseline up to 24 hours (Day 1)
Change From Baseline in Absolute Edema Volume at 96 Hours
Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO.
Time frame: Baseline up to 96 hours (Day 4)
Time to All-Cause Death Through Day 90
Time to all-cause death is defined as the time from randomization to the time of death and includes all-cause death along with neurological death.
Time frame: Randomization up to Day 90