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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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  • In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BIIB093 3 mg 		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.
  • Drug: BIIB093
    Administered as specified in the treatment arm.
    Other names:
    • Glibenclamide
    • CIRARA
    • RP 1127
Experimental
BIIB093 5 mg 		Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours.
  • Drug: BIIB093
    Administered as specified in the treatment arm.
    Other names:
    • Glibenclamide
    • CIRARA
    • RP 1127
Placebo Comparator
Placebo 		Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.
  • Drug: Placebo
    Administered as specified in the treatment arm.

More Details

Status
Terminated
Sponsor
Biogen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.