Imperial College London
Alternate

ProfessorRolandVeltkamp

Faculty of Medicine, Department of Brain Sciences

Professor of Neurology and Chair of Stroke Medicine
 
 
 
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Contact

 

r.veltkamp

 
 
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Location

 

3 East6East WingCharing Cross Campus

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Summary

 

Publications

Citation

BibTex format

@article{Elkind:2020:10.1212/WNL.0000000000010038,
author = {Elkind, MSV and Veltkamp, R and Montaner, J and Johnston, SC and Singhal, AB and Becker, K and Lansberg, MG and Tang, W and Kasliwal, R and Elkins, J},
doi = {10.1212/WNL.0000000000010038},
journal = {Neurology},
title = {Natalizumab in acute ischemic stroke (ACTION II): a randomized, placebo-controlled trial},
url = {http://dx.doi.org/10.1212/WNL.0000000000010038},
volume = {95},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 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.
AU  - Elkind,MSV
AU  - Veltkamp,R
AU  - Montaner,J
AU  - Johnston,SC
AU  - Singhal,AB
AU  - Becker,K
AU  - Lansberg,MG
AU  - Tang,W
AU  - Kasliwal,R
AU  - Elkins,J
DO  - 10.1212/WNL.0000000000010038
PY  - 2020///
SN  - 0028-3878
TI  - Natalizumab in acute ischemic stroke (ACTION II): a randomized, placebo-controlled trial
T2  - Neurology
UR  - http://dx.doi.org/10.1212/WNL.0000000000010038
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32591475
UR  - http://hdl.handle.net/10044/1/82018
VL  - 95
ER  -
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