Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial

Trials
Ji Man Hongon the behalf of the SONIC investigators

Abstract

The potential of neuroprotective agents should be revisited in the era of endovascular thrombectomy (EVT) for acute large-artery occlusion because their preclinical effects have been optimized for ischemia and reperfusion injury. Neu2000, a derivative of sulfasalazine, is a multi-target neuroprotectant. It selectively blocks N-methyl-D-aspartate receptors and scavenges for free radicals. This trial aimed to determine whether neuroprotectant administration before EVT is safe and leads to a more favorable outcome. This trial is a phase-II, multicenter, three-arm, randomized, double-blinded, placebo-controlled, blinded-endpoint drug trial that enrolled participants aged ≥ 19 years undergoing an EVT attempt less than 8 h from symptom onset, with baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 8, Alberta Stroke Program Early CT score ≥ 6, evidence of large-artery occlusion, and at least moderate collaterals on computed tomography angiography. EVT-attempted patients are randomized into control, low-dose (2.75 g), and high-dose (5.25 g) Neu2000KWL over 5 days. Seventy participants per group are enrolled for 90% power, assuming that the treatment group has a 28.4% higher proportion of participants with functional in...Continue Reading

References

Feb 22, 2002·The New England Journal of Medicine·Stephen A BernardKaren Smith
Aug 3, 2002·Stroke; a Journal of Cerebral Circulation·David J GladstoneUNKNOWN Heart and Stroke Foundation of Ontario Centre of Excellence in Stroke Recovery
Nov 16, 2006·Journal of Cerebral Blood Flow and Metabolism : Official Journal of the International Society of Cerebral Blood Flow and Metabolism·Byoung Joo GwagSung Ig Cho
Sep 26, 2008·The New England Journal of Medicine·Werner HackeUNKNOWN ECASS Investigators
Dec 10, 2008·Stroke; a Journal of Cerebral Circulation·Myron D Ginsberg
Dec 27, 2012·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Nishant P VisavadiyaJoe E Springer
Nov 10, 2013·Stroke; a Journal of Cerebral Circulation·Ji Man HongKiwon Lee
Dec 24, 2013·Progress in Neurobiology·Ted Weita LaiYu Tian Wang
Dec 18, 2014·The New England Journal of Medicine·Olvert A BerkhemerUNKNOWN MR CLEAN Investigators
Feb 12, 2015·The New England Journal of Medicine·Mayank GoyalUNKNOWN ESCAPE Trial Investigators
Jun 30, 2015·Lancet Neurology·Bruce C V CampbellStephen M Davis
Sep 24, 2015·Annals of Neurology·Mayank GoyalMarc Fisher

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Citations

Jul 12, 2019·Journal of Neuroinflammation·Richard L JayarajGary A Rosenberg
Aug 29, 2020·International Journal of Molecular Sciences·Chung-Yang YehElias Aizenman
Jan 25, 2020·Drug Discovery Today·Saeideh NozohouriThomas J Abbruscato

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Methods Mentioned

BETA
pharmacotherapy
PCA

Software Mentioned

Neu2000

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