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最高研发阶段批准上市 |
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首次获批日期2020-07-29 |
/ Not yet recruiting临床3期IIT Treatment of Acute Ischemic Stroke with Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease: a Randomized, Double-Blind, Placebo-Controlled Study
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period followed by a 28-week follow-up.
The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score.
Secondary endpoints include additional functional and cognitive assessments at 24 and 52 weeks, as well as MRI markers of white matter hyperintensities, new infarctions, microbleeds, and brain atrophy. Safety assessments will include adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.
Clinical efficacy of edaravone dexborneol combined with hyperbaric oxygen therapy (HBOT) in the treatment of acute ischemic stroke based on real-world data - A study on clinical efficacy of edaravone dexborneol combined with hyperbaric oxygen therapy (HBOT) in the treatment of acute ischemic stroke
/ Not yet recruiting临床4期IIT Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.
100 项与 CPT1A x PRDX1 相关的临床结果
100 项与 CPT1A x PRDX1 相关的转化医学
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