NCT01955707

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	natalizumab	Administered as described in the treatment arm
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2013-10-07
• Last updated: 2016-07-01
• Results posted: 2016-07-01

Locations

50 sites across 3 countries: United States, Germany, Spain