The TASTE-SL (Treatment of Acute Ischemic Stroke with Sublingual Edaravone Dextanone) randomized clinical trial aimed to investigate the efficacy and safety of sublingual edaravone dextanone in improving 90-day functional outcomes in patients with acute ischemic stroke (AIS). The study was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China and included patients aged 18 to 80 years with a National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20, a total motor deficit score of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke.
Patients were randomly assigned in a 1:1 ratio to receive sublingual edaravone dextanone (edaravone 30 mg, dextanone 6 mg) or placebo (edaravone 0 mg, dextanone 60 μg) twice daily for 14 days. The primary efficacy outcome was the proportion of patients with an mRS score of 1 or less on day 90 after randomization. Secondary outcomes included mRS scores, NIHSS scores, and adverse events.
The study found that the sublingual edaravone dextanone group had a significantly higher proportion of patients with good functional outcomes (mRS score of 1 or less) compared to the placebo group (64.4% vs 54.7%, risk difference 9.70%, P = .003). The rate of adverse events was similar between the two groups. The study concluded that sublingual edaravone dextanone can improve the proportion of patients achieving favorable functional outcomes at 90 days compared to placebo, without increasing the risk of adverse events. This innovative, multitarget brain cytoprotective agent offers several clinical advantages, including faster onset of action, lower dose requirement, better patient compliance, and increased bioavailability.The TASTE-SL (Treatment of Acute Ischemic Stroke with Sublingual Edaravone Dextanone) randomized clinical trial aimed to investigate the efficacy and safety of sublingual edaravone dextanone in improving 90-day functional outcomes in patients with acute ischemic stroke (AIS). The study was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China and included patients aged 18 to 80 years with a National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20, a total motor deficit score of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke.
Patients were randomly assigned in a 1:1 ratio to receive sublingual edaravone dextanone (edaravone 30 mg, dextanone 6 mg) or placebo (edaravone 0 mg, dextanone 60 μg) twice daily for 14 days. The primary efficacy outcome was the proportion of patients with an mRS score of 1 or less on day 90 after randomization. Secondary outcomes included mRS scores, NIHSS scores, and adverse events.
The study found that the sublingual edaravone dextanone group had a significantly higher proportion of patients with good functional outcomes (mRS score of 1 or less) compared to the placebo group (64.4% vs 54.7%, risk difference 9.70%, P = .003). The rate of adverse events was similar between the two groups. The study concluded that sublingual edaravone dextanone can improve the proportion of patients achieving favorable functional outcomes at 90 days compared to placebo, without increasing the risk of adverse events. This innovative, multitarget brain cytoprotective agent offers several clinical advantages, including faster onset of action, lower dose requirement, better patient compliance, and increased bioavailability.