For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 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.
  2. A score of 5 to 15 on the Glasgow Coma Scale (GCS).
  3. Functionally independent, in the opinion of the Investigator, prior to index head injury. Key

EXCLUSION CRITERIA

  1. In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.
  2. Indication for immediate evacuation of IPH or DC.
  3. Clinical signs of brainstem herniation, in the opinion of the Investigator.
  4. 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).
  5. Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination.
  6. Presence of concomitant spinal cord injury as assessed by imaging and clinical examination.
  7. Life-threatening or nonsurvivable polytrauma, per Investigator's judgment.
  8. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 866-633-4636Email iconEmail Study Center

Study’s details


Contition

Brain Contusion

Age

18+

Phase

Phase 2

Participants needed

90

Est. Completion Date

Jun 2025

Treatment type

Interventional


Sponsor

Biogen

ClinicalTrials.gov identifier

NCT03954041

Study number

252BN201

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