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• In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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.