Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial. Issue 11 (6th September 2022)

• Record Type: Journal Article
• Authors: Hong, Ji Man; Lee, Jin Soo; Lee, Yeong-Bae; Shin, Dong Hoon; Shin, Dong-Ick; Hwang, Yang-Ha; Ahn, Seong Hwan; Kim, Jae Guk; Sohn, Sung-Il; Kwon, Sun U.; Lee, Ji Sung; Gwag, Byoung Joo; Chamorro, Ángel; Choi, Dennis W.
• Other Names: Chammorro Ángel author non-byline.; Kim Eung Yeop author non-byline.; Choi Jin Wook author non-byline.; Yeo Min-Ju author non-byline.; Kwak Jaehyuk author non-byline.; Lee Sung Eun author non-byline.; Hong Jeong-Ho author non-byline.; Lee Sangkil author non-byline.; Lee Yoon-Joo author non-byline.; Lee Min-Joo author non-byline.
• Is Part Of: Stroke. Volume 53:Issue 11(2022)
• Page Start: 3250
• Page End: 3259
• Publication Date: 2022-09-06
• Subjects: cerebral infarction -- ischemic stroke -- neuroprotective agent -- odds ratio -- reperfusion; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.122.039649
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : Background: Nelonemdaz is a multitarget neuroprotectant that selectively blocks N-methyl-D-aspartate receptors and scavenges free radicals, as proven in preclinical ischemia-reperfusion studies. We aimed to evaluate the safety and efficacy of nelonemdaz in patients with acute ischemic stroke receiving endovascular reperfusion therapy. Methods: This phase II randomized trial involved participants with large-artery occlusion in the anterior circulation at baseline who received endovascular reperfusion therapy <8 hours from symptom onset at 7 referral stroke centers in South Korea between October 29, 2016, and June 1, 2020. Two hundred thirteen patients were screened and 209 patients were randomly assigned at a 1:1:1 ratio using a computer-generated randomization system. Patients were divided into 3 groups based on the medication received—placebo, low-dose (2750 mg) nelonemdaz, and high-dose (5250 mg) nelonemdaz. The primary outcome was the proportion of patients with modified Rankin Scale scores of 0–2 at 12 weeks. Results: Two hundred eight patients were assigned to the placebo (n=70), low-dose (n=71), and high-dose (n=67) groups. The groups had similar baseline characteristics. The primary outcome was achieved in 183 patients, and it did not differ among the groups (33/61 [54.1%], 40/65 [61.5%], and 36/57 [63.2%] patients; P =0.5578). The common odds ratio (90% CI) indicating a favorable shift in the modified Rankin Scale scores at 12 weeks was 1.55 (0.92–2.60) between the placebo and low-dose groups and 1.61 (0.94–2.76) between the placebo and high-dose groups. No serious adverse events were reported. Conclusions: The study arms showed no significant difference in the proportion of patients achieving modified Rankin Scale scores of 0–2 at 12 weeks. Nevertheless, nelonemdaz-treated patients showed a favorable tendency toward achieving these scores at 12 weeks, without serious adverse effects. Thus, a large-scale phase III trial is warranted. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT02831088.