Overview

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

Status:
Recruiting
Trial end date:
2022-05-29
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biogen
Treatments:
Glyburide
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withdrawn within 24 hours.

- 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.

- Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical
management, if known. Minor fractures requiring splinting or reduction of dislocations
are permitted, as are nonoperative intra-abdominal injuries or placement of
noninvasive external fixation devices.

- 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.