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

Remedy Pharmaceuticals, Inc.

Status and phase: Terminated; Phase 2

Conditions: Brain Contusion

Treatments: Drug: Placebo; Drug: BIIB093

Study type: Interventional

Funder types: Industry

Identifiers

NCT03954041

2018-003858-24 (EudraCT Number)

252BN201

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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• In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 3 patient groups, including a placebo group

BIIB093 3 mg

Experimental group

Description:

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.

Treatment:

Drug: BIIB093

BIIB093 5 mg

Experimental group

Description:

Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours.

Treatment:

Drug: BIIB093

Placebo

Placebo Comparator group

Description:

Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.

Treatment:

Drug: Placebo