A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants with Brain Contusio

Phase 1

Conditions: Brain contusion
MedDRA version: 20.0Level: PTClassification code 10052346Term: Brain contusionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2018-003858-24-ES

Lead Sponsor: Biogen Idec Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 160

Inclusion 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 14 on the Glasgow Coma Scale (GCS)
• Functionally independent, in the opinion of the Investigator, prior to index head injury.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

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• In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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 injury.
• 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 is permitted, as are nonoperative intraabdominal injuries.
•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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.;Secondary Objective: 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<br>hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.;Timepoint(s) of evaluation of this end point: Within 96 hours of start of study treatment infusion;Primary end point(s): Proportion of Participants With Contusion Expansion.<br><br>Participants with contusion expansion will be determined by comparison of the baseline images and the 96-hour scan or the scan obtained prior to any neurosurgical intervention (NSx) or comfort measures only (CMO). NSx includes craniotomy and decompressive<br>craniectomy (DC).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of Participants With Improvement in Glasgow Outcome Scale – Extended (GOS-E).<br>- Proportion of Participants With Improvement in Modified Rankin Scale (mRS).<br>- Proportion of Participants Requiring Delayed Intubation<br>- Change from Baseline in Absolute Hematoma Volume at Hour 24<br>- Change from Baseline in Absolute Edema Volume at Hour 96<br>- Time to All-cause Death;Timepoint(s) of evaluation of this end point: - GOS-E: Day 90<br>- mRS: Day 90<br>- Delayed Intubation: Day 1 (Hour 24) to Day 4 (Hour 96)<br>- Absolute Hematoma: Baseline up to Day 1 (Hour 24)<br>- Absolute Edema Volume: Baseline up to Day 4 (Hour 96)<br>- All-cause Death: Baseline up to Day 90

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