Brain Contusion
Conditions
Brief summary
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.
Interventions
DRUGBIIB093
Administered as specified in the treatment arm.
DRUGPlacebo
Administered as specified in the treatment arm.
Sponsors
Remedy Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling \>3 mL in volume per Investigator assessment of baseline non-contrast computed tomography scan (NCCT) at Screening. * A score of 5 to 15 on the Glasgow Coma Scale (GCS). * Functionally independent, in the opinion of the Investigator, prior to index head injury. Key
Exclusion criteria
* In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours. * Indication for immediate evacuation of IPH or DC. * Clinical signs of brainstem herniation, in the opinion of the Investigator. * NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain parenchyma. Cerebrospinal fluid leak in isolation is not exclusionary unless evidence of parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed skull fracture). * Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination. * Presence of concomitant spinal cord injury as assessed by imaging and clinical examination. * Life-threatening or nonsurvivable polytrauma, per Investigator's judgment. * Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3 days prior to the injury, if known. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Baseline up to 96 hours (Day 4) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | 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. |
| Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | 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. |
| Percentage of Participants Requiring Delayed Intubation | Day 1 (24 hours) up to Day 4 (96 hours) post-injury | Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury. |
| Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Baseline up to 24 hours (Day 1) | 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. |
| Change From Baseline in Absolute Hematoma Volume at 24 Hours | Baseline up to 24 hours (Day 1) | 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. |
| Change From Baseline in Absolute Edema Volume at 96 Hours | Baseline up to 96 hours (Day 4) | 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 to All-Cause Death Through Day 90 | Randomization up to 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. |
Countries
France, Germany, Israel, Italy, Japan, Spain, United States
Participant flow
Recruitment details
Participants were enrolled at study centers in Israel, France, Japan, Italy, Spain, and the United States.
Pre-assignment details
A total of 92 participants were enrolled and randomized, out of which 86 participants were dosed with BIIB093 or a matching placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were administered with BIIB093 matching placebo as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 44 |
| BIIB093 3 mg/Day Participants were administered with BIIB093 up to 3 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 21 |
| BIIB093 5 mg/Day Participants were administered with BIIB093 up to 5 mg/day as an IV bolus followed by a rapid IV infusion and a slow IV infusion for 4 days. | 21 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 0 | 1 |
| Overall Study | Death by neurologic criteria | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 | 6 |
| Overall Study | Reason not specified | 7 | 4 | 2 |
| Overall Study | Withdrew prior to dosing | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | BIIB093 3 mg/Day | BIIB093 5 mg/Day |
|---|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 17.39 | 59.3 years STANDARD_DEVIATION 14.18 | 55.7 years STANDARD_DEVIATION 19.87 | 55.0 years STANDARD_DEVIATION 21.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 39 Participants | 15 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 3 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 22 Participants | 12 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Reported | 9 Participants | 2 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 51 Participants | 26 Participants | 12 Participants | 13 Participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 72 Participants | 36 Participants | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 44 | 0 / 23 | 2 / 19 |
| other Total, other adverse events | 36 / 44 | 20 / 23 | 18 / 19 |
| serious Total, serious adverse events | 12 / 44 | 7 / 23 | 8 / 19 |
Outcome results
Primary
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)
Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Baseline | 29.45 mL | Standard Deviation 29.688 |
| Placebo | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Change From Baseline at 96 Hours | 18.91 mL | Standard Deviation 23.804 |
| BIIB093 3 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Baseline | 21.21 mL | Standard Deviation 26.659 |
| BIIB093 3 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Change From Baseline at 96 Hours | 30.07 mL | Standard Deviation 29.418 |
| BIIB093 5 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Baseline | 21.33 mL | Standard Deviation 26.637 |
| BIIB093 5 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging | Change From Baseline at 96 Hours | 18.78 mL | Standard Deviation 12.771 |
Comparison: Statistical analysis of combined BIIB093 vs placebop-value: =0.375295% CI: [-5.74, 14.98]ANCOVA
Secondary
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)
Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute Edema Volume at 96 Hours | Baseline | 22.41 mL | Standard Deviation 23.234 |
| Placebo | Change From Baseline in Absolute Edema Volume at 96 Hours | Change From Baseline at 96 Hours | 16.13 mL | Standard Deviation 20.872 |
| BIIB093 3 mg/Day | Change From Baseline in Absolute Edema Volume at 96 Hours | Baseline | 15.10 mL | Standard Deviation 16.366 |
| BIIB093 3 mg/Day | Change From Baseline in Absolute Edema Volume at 96 Hours | Change From Baseline at 96 Hours | 25.87 mL | Standard Deviation 27.772 |
| BIIB093 5 mg/Day | Change From Baseline in Absolute Edema Volume at 96 Hours | Baseline | 17.52 mL | Standard Deviation 24.103 |
| BIIB093 5 mg/Day | Change From Baseline in Absolute Edema Volume at 96 Hours | Change From Baseline at 96 Hours | 14.98 mL | Standard Deviation 10.459 |
Comparison: Statistical analysis of combined BIIB093 vs placebop-value: =0.656995% CI: [-7.61, 11.98]ANCOVA
Secondary
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)
Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Baseline | 6.72 mL | Standard Deviation 10.012 |
| Placebo | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Change From Baseline at 24 Hours | 2.07 mL | Standard Deviation 5.92 |
| BIIB093 3 mg/Day | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Baseline | 6.11 mL | Standard Deviation 12.086 |
| BIIB093 3 mg/Day | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Change From Baseline at 24 Hours | 2.13 mL | Standard Deviation 3.667 |
| BIIB093 5 mg/Day | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Baseline | 3.62 mL | Standard Deviation 3.737 |
| BIIB093 5 mg/Day | Change From Baseline in Absolute Hematoma Volume at 24 Hours | Change From Baseline at 24 Hours | 2.23 mL | Standard Deviation 3.537 |
Comparison: Statistical analysis of combined BIIB093 vs placebop-value: =0.931495% CI: [-2.2, 2.02]ANCOVA
Secondary
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)
Population: mITT population=all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. 'Number analyzed' signifies number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Baseline | 29.45 mL | Standard Deviation 29.688 |
| Placebo | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Change From Baseline at 24 Hours | 8.16 mL | Standard Deviation 18.824 |
| BIIB093 3 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Baseline | 21.21 mL | Standard Deviation 26.659 |
| BIIB093 3 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Change From Baseline at 24 Hours | 11.24 mL | Standard Deviation 13.909 |
| BIIB093 5 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Baseline | 21.33 mL | Standard Deviation 26.637 |
| BIIB093 5 mg/Day | Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging | Change From Baseline at 24 Hours | 6.67 mL | Standard Deviation 13.483 |
Comparison: Statistical analysis of combined BIIB093 vs placebop-value: =0.647895% CI: [-8.19, 5.13]ANCOVA
Secondary
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
Population: mITT population included all the randomized participants who received any study drug (BIIB093 or placebo) and had at least one final read per central review of contusion volume from a NCCT or MRI scan acquired between 10 hours after the initiation of study drug infusion and the Hour 96 visit or NSx or CMO, if earlier.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Requiring Delayed Intubation | 2.3 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants Requiring Delayed Intubation | 4.8 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants Requiring Delayed Intubation | 0 Percentage of participants |
Secondary
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
Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit/NSx/CMO. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 3 | 13.3 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 6 | 26.7 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 5 | 13.3 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 1/2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 8 | 40.0 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 7 | 6.7 Percentage of participants |
| Placebo | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 4 | 0 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 5 | 6.7 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 1/2 | 0 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 3 | 13.3 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 4 | 26.7 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 6 | 0 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 7 | 13.3 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 8 | 40.0 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 6 | 0 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 3 | 27.3 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 8 | 36.4 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 7 | 27.3 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 5 | 0 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 4 | 9.1 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180 | Score: 1/2 | 0 Percentage of participants |
Comparison: Statistical analysis of combined BIIB093 vs placebo95% CI: [0.4, 3.36]
Secondary
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
Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT/MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 4 | 10.3 Percentage of participants |
| Placebo | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 3 | 12.8 Percentage of participants |
| Placebo | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 0/1 | 38.5 Percentage of participants |
| Placebo | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 2 | 25.6 Percentage of participants |
| Placebo | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 5/6 | 12.8 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 3 | 21.1 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 0/1 | 31.6 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 2 | 26.3 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 4 | 15.8 Percentage of participants |
| BIIB093 3 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 5/6 | 5.3 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 5/6 | 14.3 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 4 | 21.4 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 0/1 | 57.1 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 3 | 0 Percentage of participants |
| BIIB093 5 mg/Day | Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90 | Score: 2 | 7.1 Percentage of participants |
Comparison: Statistical analysis of combined BIIB093 vs placebop-value: =0.430695% CI: [0.56, 3.86]Regression, Logistic
Secondary
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
Population: mITT population included all randomized participants who received any study drug (BIIB093/placebo), had at least one final read per central review of contusion volume from NCCT or MRI scan acquired between 10 hours after study drug infusion initiation and Hour 96 visit or NSx or CMO, if earlier. 'Overall number of participants analyzed' signifies the number of participants who died from randomization up to Day 90.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to All-Cause Death Through Day 90 | NA days |
| BIIB093 5 mg/Day | Time to All-Cause Death Through Day 90 | NA days |