Evidence map›Paper›PMID 32591475›Full record

Trial reportNeurology2020

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

Mitchell S V Elkind, Roland Veltkamp, Joan Montaner, S Claiborne Johnston, Aneesh B Singhal, Kyra Becker, Maarten G Lansberg, Weihua Tang, Rachna Kasliwal, Jacob Elkins

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02730455 (Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02730455 phase2completednot on this map

Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

TypeinterventionalSponsorBiogenRan2016 to 2017Enrolled277ConditionsAcute Ischemic StrokeArmsnatalizumab, Placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
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  9. Overestimation of ischemic core on baseline MRI in acute stroke.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Mitchell S V ElkindFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA. mse13@columbia.edu.
Roland VeltkampFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Joan MontanerFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
S Claiborne JohnstonFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Aneesh B SinghalFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Kyra BeckerFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Maarten G LansbergFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Weihua TangFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Rachna KasliwalFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Jacob ElkinsFrom Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.
Alfried Krupp Hospital · DEImperial College London · GBMassachusetts General Hospital · USStanford Medicine · USUniversity of Washington · USVall d'Hebron Institut de Recerca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

methodsIn 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;

resultsAn excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 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 (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).

conclusionsNatalizumab 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.

Indexed as

AgedBrain IschemiaDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansImmunologic FactorsMaleMiddle AgedNatalizumabRecovery of FunctionStrokeImmunologic FactorsNatalizumab

Identifiers

PMID32591475
PMCPMC7668547
OpenAlexW3037542909

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.