Natalizumab in acute ischemic stroke (ACTION II)
| Autor: | Mitchell S.V. Elkind, Roland Veltkamp, Rachna Kasliwal, Joan Montaner, Jacob Elkins, S. Claiborne Johnston, Kyra Becker, Weihua Tang, Maarten G Lansberg, Aneesh B. Singhal |
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| Přispěvatelé: | Commission of the European Communities |
| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Randomization 1702 Cognitive Sciences Placebo-controlled study Placebo Brain Ischemia law.invention 03 medical and health sciences 0302 clinical medicine Natalizumab Double-Blind Method Randomized controlled trial law Modified Rankin Scale Internal medicine Clinical endpoint medicine Humans Immunologic Factors Aged Neurology & Neurosurgery Dose-Response Relationship Drug business.industry 1103 Clinical Sciences Recovery of Function Middle Aged Confidence interval 3. Good health Stroke 030104 developmental biology Female Neurology (clinical) 1109 Neurosciences business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Neurology. 95:e1091-e1104 |
| ISSN: | 1526-632X 0028-3878 |
| DOI: | 10.1212/wnl.0000000000010038 |
| Popis: | 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;pvalues were not used for hypothesis testing.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.ClinicalTrials.gov identifierNCT02730455Classification of evidenceThis study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo. |
| Databáze: | OpenAIRE |
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