A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 63
- 主要终点
- Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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.
研究组 & 干预措施
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.
干预措施: BIIB093 (Drug)
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.
干预措施: BIIB093 (Drug)
Placebo
Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
时间窗: Baseline up to 96 hours (Day 4)
Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging \[MRI\] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).
次要结局
- Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180(Day 180)
- Change From Baseline in Absolute Hematoma Volume at 24 Hours(Baseline up to 24 hours (Day 1))
- Change From Baseline in Absolute Edema Volume at 96 Hours(Baseline up to 96 hours (Day 4))
- Time to All-Cause Death Through Day 90(Randomization up to Day 90)
- Percentage of Participants Requiring Delayed Intubation(Day 1 (24 hours) up to Day 4 (96 hours) post-injury)
- Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging(Baseline up to 24 hours (Day 1))
- Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90(Day 90)