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Loberamisal, a small-molecule, dually targets the PSD-95 pathway and the α2-GABAA receptor. In the LAIS multicenter, double-blind, randomized, placebo-controlled phase 3 trial, adults enrolled within 48 hours of symptom onset received intravenous loberamisal or placebo once daily for 10 days, alongside standard care. At 90 days, more loberamisal-treated patients achieved mRS 0–1.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/loberamisal-for-acute-ischemic-stroke-lais-randomized-clinical-trial/436428/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/loberamisal-for-acute-ischemic-stroke-lais-randomized-clinical-trial/436428.png","ImageObject",300,407,{"name":92,"@type":93},"Fans","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-05","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is loberamisal intended to do in acute ischemic stroke?","Question",{"text":112,"@type":113},"Loberamisal is designed as a dual-target therapy that interferes with PSD-95 pathway signaling and positively modulates the α2-GABAA receptor, aiming to support neuroprotection and neurorecovery.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was the LAIS trial designed and conducted?",{"text":117,"@type":113},"The LAIS study was a multicenter, double-blind, randomized, placebo-controlled phase 3 trial conducted at 32 hospitals in China.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the primary and key safety outcomes?",{"text":121,"@type":113},"The primary outcome was full functional outcome at 90 days (mRS 0–1). Safety outcomes included adverse events, serious adverse events, and all-cause mortality.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},436428,1790854841,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},5909892330395,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Research  \nJAMA | Original Investigation  \nLoberamisal for Acute Ischemic Stroke The LAIS Randomized Clinical Trial  \nShuya Li, MD; Baoyu Feng, PhD; Dandan He, PhD; Xuechun Wang, PhD; Hao Li, PhD; Shuhong Xu, PhD; Hong-Qiu Gu, PhD; Xiaohua Xiao, MD; Dan Deng, MD; Xiaoli Wang, MD; Aihong Guo, MD; Hongguo Dai, MD; Zixiao Li, MD; Yilong Wang, MD; Xingquan Zhao, MD; Liping Liu, MD; Yongjun Wang, MD; for the LAIS investigators  \nIMPORTANCE Effective neuroprotective and neuroreparative therapies for acute ischemic stroke remain limited. Loberamisal is a small-molecule compound that dually targets the postsynaptic density 95 (PSD-95) pathway and α2 γ-aminobutyric acid type α (α2-GABAA)  \nreceptor.  \nOBJECTIVE To evaluate the efficacy and safety of intravenous loberamisal for improving functional outcomes in patients with acute ischemic stroke.  \nDESIGN, SETTING, AND PARTICIPANTS The Loberamisal for Acute Ischemic Stroke (LAIS) trial was a multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial conducted at 32 hospitals in China. Adults aged 18 to 80 years with acute ischemic stroke, a baseline National Institutes of Health Stroke Scale score of 7 to 20, and no prestroke disability (modified Rankin Scale score, 􀀂1) who presented within 48 hours of symptom onset were enrolled between July 24, 2024, and December 7, 2024, with final follow-up on April 8, 2025 .  \nINTERVENTIONS Participants were randomly assigned (1:1) to receive intravenous loberamisal (40 mg) or matching placebo once daily for 10 consecutive days, in addition to standard stroke care.  \nMAIN OUTCOMESAND MEASURES The primary outcome was achieving a full functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 1. Safety outcomes included adverse events, serious adverse events, and mortality.  \nRESULTS Among 998 randomized participants, 997 received at least 1 dose of the study drug and were included in the primary analysis (502 in the loberamisal group and 495 in the placebo group) . The median age was 64 years (IQR, 57-71), 336 participants (33 .7%) were women, and the median baseline NIHSS score was 8 (IQR, 7-9) . At 90 days, 350 participants (69.7%) in the loberamisal group achieved an mRS score of 0 to 1 compared with 279 (56.3%) in the placebo group (relative risk, 1.24; 95% CI, 1.12-1.36; risk difference, 13.28%; 95% CI, 7.24%-19.32%). Adverse events occurred in 441 participants (87.8%) in the loberamisal group and 439 (88 .7%) in the placebo group. Serious adverse events occurred in 43 participants (8.6%) in the loberamisal group and 53 (10.7%) in the placebo group. All-cause mortality occurred in 6 participants (1 .2%) in the loberamisal group and 10 (2 .0%) in the placebo group.  \nCONCLUSIONSAND RELEVANCE Among patients with acute ischemic stroke treated within 48 hours of symptom onset, intravenous loberamisal, compared with placebo, resulted in a higher proportion of patients achieving full functional outcomes at 90 days. Further studies are needed to validate these findings and establish whether the benefits could extend to a broader patient population.  \nTRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT06517173  \nJAMA. doi:10.1001/jama.2026.16557 Published online September 10, 2026.  \n Visual Abstract  \n Research Summary  \n Editorial  \n Supplemental content  \nAuthor Affiliations: Author affiliations are listed at the end of this article.  \nGroup Information: A full list of the  \nLAIS investigators appears in  \nSupplement 4 .  \nCorresponding Authors: Yongjun Wang, MD(yongjunwang@ncrcnd.  \n[org.cn](org.cn)), and Shuya Li, MD (shuyali85 @[163.com](163.com)), Department of Neurology, Beijing Tiantan Hospital,  \nNo. 119 S Fourth Ring W Rd, Fengtai  \nDistrict, Beijing 100070, China.  \nE1  \n© 2026 American Medical Association. All rights reserved, including those for text and data mining, AI training, and similar technologies.  \nResearch Original Investigation Loberamisal for Acute Ischemic Stroke  \nD  \nespite","cbCaifRBKXxXwNME","https://ap.wps.com/l/cbCaifRBKXxXwNME","pdf",217668,"English","# Importance\n# Objective\n# Design, Setting, and Participants\n# Interventions\n# Main Outcomes and Measures\n# Results\n# Conclusions and Relevance\n# Trial Registration","[{\"question\":\"What is loberamisal intended to do in acute ischemic stroke?\",\"answer\":\"Loberamisal is designed as a dual-target therapy that interferes with PSD-95 pathway signaling and positively modulates the α2-GABAA receptor, aiming to support neuroprotection and neurorecovery.\"},{\"question\":\"How was the LAIS trial designed and conducted?\",\"answer\":\"The LAIS study was a multicenter, double-blind, randomized, placebo-controlled phase 3 trial conducted at 32 hospitals in China.\"},{\"question\":\"What were the primary and key safety outcomes?\",\"answer\":\"The primary outcome was full functional outcome at 90 days (mRS 0–1). Safety outcomes included adverse events, serious adverse events, and all-cause mortality.\"}]","Loberamisal for Acute Ischemic Stroke - LAIS Randomized Clinical Trial | PDF",1790677906,23]