Conditions: Acute Ischemic Stroke
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 161
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 300 mg single intravenous (IV) injection arm 2: A single IV dose of placebo

Interventions: intervention 1: natalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as described in the treatment arm intervention 2: Matched placebo

Protocol document: