A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) on Reducing Infarct Volume in Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])
研究概览
简要总结
The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at >6 to ≤9 hours from when they were last known normal (LKN).
The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.
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
- Double (Participant, Investigator)
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
- •Diagnosis of acute ischemic stroke.
- •Score of ≥6 points on the National Institute of Health Stroke Scale (NIHSS) at Screening.
- •At least 1 acute infarct with largest diameter of more than 2 cm on Baseline brain diffusion-weighted imaging (DWI).
- •Participants who have received reperfusion therapy may be eligible to participate but must meet all eligibility criteria and perform the Baseline study magnetic resonance imaging (MRI) after reperfusion therapy has been completed.
- •Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 3 months after their dose of study treatment.
排除标准
- •Presence of any intracranial hemorrhage (ICH) on head computed tomography (CT) or non-petechial ICH on screening MRI.
- •Stroke isolated to the brainstem.
- •Presence of coma
- •Expected to die OR unable to be evaluated within 5 days.
- •Hypotension requiring the use of intravenous (IV) vasopressor support or systolic blood pressure <90 mmHg at the time of randomization.
- •Known prior treatment with natalizumab.
- •Immunocompromised subjects, as determined by the Investigator.
- •History of progressive multifocal leukoencephalopathy (PML).
- •Contraindications to MRI, e.g., implanted pacemaker or other contraindicated implanted metal devices, history of or risk for side effects from gadolinium, or claustrophobia that cannot be medically managed.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
A single IV dose of placebo
干预措施: Placebo (Drug)
natalizumab
300 mg single intravenous (IV) injection
干预措施: natalizumab (Drug)
结局指标
主要结局
Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])
时间窗: Baseline, Day 5
Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.
次要结局
- Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)(24 hours, Day 30)
- Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)(Baseline, Day 30)
- Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)(24 hours, Day 5)
- Barthel Index at Day 5, Day 30, and Day 90(Day 5, Day 30, and Day 90)
- Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)(Day 5, Day 30)
- Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)(Baseline, 24 hrs)
- Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90(Day 5, Day 30, and Day 90)
- Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90(Baseline, 24 hours, Day 5, Day 30, Day 90)
- Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 90 ± 5 days)