The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS
Status:
Not yet recruiting
Trial end date:
2025-05-30
Target enrollment:
Participant gender:
Summary
SIM0308-302 is a multicenter, randomized, double-blind, placebo-controlled clinical III trial
with the primary objective of evaluating the efficacy of Edaravone Dexborneol sequential
therapy, consisting of Edaravone Dexborneol Injections followed by Edaravone Dexborneol
Sublingual Tablets for total 14 days, in patients with acute ischemic stroke (AIS). The
subject has a clinical diagnosis of AIS, within 48 hours from stroke onset to start of study
treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a
total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the
proportion of subjects with modified Rankin scale score ≤ 2 at 90 days after treatment.