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

Biogen Idec Research Limited0 个研究点目标入组 160 人开始时间: 2019年6月11日最近更新: 2021年6月7日

研究概览

暂无简介。

•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

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•In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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

发起方