EUCTR2018-003858-24-IT进行中（未招募）1 期
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 - .
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •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
排除标准
- •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- •supportive care withdrawn within 24 hours.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 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.
- •Polytrauma (intra-abdominal or orthopedic trauma) requiring
- •operative/surgical management, if known.
- •Minor fractures requiring splinting or reduction of dislocations are
- •permitted, as are nonoperative intraabdominal injuries or
- •placement of noninvasive external fixation devices.
- •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.
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants with Brain ContusioEUCTR2018-003858-24-ESBiogen Idec Research Limited160
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized Placebo-Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Type I Diabetic Male and Female Patients with GastroparesisDiabetic GastroparesisEUCTR2008-008175-34-SEGlaxoSmithKline Research & Development Ltd18
进行中（未招募）
不适用
A Multicenter, Double-Blind, Randomized Placebo-Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Type I Diabetic Male and Female Patients with GastroparesisDiabetic GastroparesisEUCTR2008-008175-34-BEGlaxoSmithKline Research & Development Ltd18
进行中（未招募）
1 期
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK-0594 in Patients With Overactive Bladder - NDoveractove bladderMedDRA version: 6.1 Level: PT Classification code 10046494EUCTR2005-006201-12-ITMERCK SHARP DOHME530
进行中（未招募）
1 期
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK-0594 in Patients With Overactive Bladder - MK-0594 Overactive Bladder Dose-Ranging StudyOveractive BladderEUCTR2005-005606-23-DKMerck & Co. Inc.530