A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

Phase 2

Terminated

Conditions: Brain Contusion

Interventions: Drug: BIIB093
Drug: Placebo

Registration Number: NCT03954041

Lead Sponsor: Remedy Pharmaceuticals, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 92

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In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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/Exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIIB093 3 mg	BIIB093	Participants will be administered BIIB093 3 milligrams per day (mg/day) as a IV bolus followed by rapid and slow intravenous (IV) infusions for 96 hours.
Placebo	Placebo	Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.
BIIB093 5 mg	BIIB093	Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (63): 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
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Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States