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

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Title: Natalizumab in acute ischemic stroke (ACTION II): a randomized, placebo-controlled trial
Authors: Elkind, MSV
Veltkamp, R
Montaner, J
Johnston, SC
Singhal, AB
Becker, K
Lansberg, MG
Tang, W
Kasliwal, R
Elkins, J
Item Type: Journal Article
Abstract: OBJECTIVE: We evaluated the effect of two doses of natalizumab on functional outcomes in acute ischemic stroke (AIS) patients. METHODS: In this double-blind phase 2b trial, AIS patients aged 18-80 years with National Institutes of Health 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 intravenous 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: An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90%, 92%, and 92%, respectively), serious adverse events (26%, 33%, and 21%, respectively), or deaths (7%, 5%, and 6%, respectively). CONCLUSIONS: Natalizumab administered ≤24 hours after AIS did not improve patient outcomes. CLINICALTRIALSGOV IDENTIFIER: NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.
Issue Date: 25-Aug-2020
Date of Acceptance: 14-Feb-2020
URI: http://hdl.handle.net/10044/1/82018
DOI: 10.1212/WNL.0000000000010038
ISSN: 0028-3878
Publisher: Lippincott, Williams & Wilkins
Journal / Book Title: Neurology
Volume: 95
Issue: 8
Copyright Statement: © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloadingand sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Sponsor/Funder: Commission of the European Communities
Funder's Grant Number: 754517
Keywords: Neurology & Neurosurgery
1103 Clinical Sciences
1109 Neurosciences
1702 Cognitive Sciences
Publication Status: Published
Conference Place: United States
Online Publication Date: 2020-06-26
Appears in Collections:Department of Brain Sciences

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