Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial.

ABSTRACT:

Objective

We evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).

Methods

In this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model; p values were not used for hypothesis testing.

Results

A

SUBMITTER: Elkind MSV 

PROVIDER: S-EPMC7668547 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature