Abstract TP15: Rationale And Ongoing Status In A Phase 3 Trial Of Nelonemdaz, A Novel Neuroprotection Drug, For Patients With Acute Ischemic Stroke And Reperfusion

Autor: Jin Soo Lee, Ji Sung Lee, Byoung Joo Gwag, Dennis W Choi, Chun San An, Hyun Goo Kang, Tae-Jin Song, Seong Hwan Ahn, Chang Hun Kim, Sun U Kwon
Rok vydání: 2023
Předmět:
Zdroj: Stroke. 54
ISSN: 1524-4628
0039-2499
DOI: 10.1161/str.54.suppl_1.tp15
Popis: Background: A phase III Rescue On reperfusion Damage in cerebral Infarction by Nelonemdaz (RODIN) trial has been launched since December, 2021 and patients are being enrolled. Rationale: Nelonemdaz (previously, neu2000) targets (1) selectively the 2B subunit of the N-methyl-D-aspartate glutamate receptor, the activation of which causes Na+ and Ca++ influx into neuronal cells and then induces downstream death-signaling pathways, and (2) free radical species, which are released both from the downstream pathways of glutamate receptors and from following reperfusion injury. Phase I and II trials showed its safety and a tendency of clinical outcome improvements. Methods: RODIN is a multicenter, double-blinded clinical trial. A total of 496 patients will be randomly assigned into nelonemdaz and placebo groups. Patients will be included if they have an acute ischemic stroke (National Institutes of Health Stroke Scale score ≥8 scores) caused by intracranial large vessel occlusion in the anterior circulation (Alberta Stroke Program Early CT Score ≥4), and they are expected to undergo endovascular thrombectomy within 12 hours after stroke onset. The primary endpoint is a favorable shift in the modified Rankin Scale (mRS) score at 90 days after the first dose of drug, analyzed by the Cochran-Mantel-Haenszel shift test. Ongoing status: By August 23, 2022, 210 patients have been enrolled. It is expected that enrollment could be finalized until spring season of 2023. Conclusions: This trial will clarify the efficacy and safety of nelonemdaz in patients with acute ischemic stroke and endovascular thrombectomy. This study was registered in ClinicalTrials.gov, number NCT05041010.
Databáze: OpenAIRE
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