drugset / Trial / NCT02430350

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

NCT02430350 ↗

Phase 3 Completed 1200 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Timeline

Start
2015-05
Primary completion
2016-12
Completion
2016-12

Outcome

Met primary endpoint

paper The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12-1.81]; P=0.004). PMID 33588596 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Edaravone Unknown 30 mg Intravenous
Subject Edaravone Dexborneol Unknown 37.5 mg Intravenous

Indications