Acute Ischemic Stroke Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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