drugset / Trial / NCT02430350
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Edaravone | Unknown | 30 mg | Intravenous |
| Subject | Edaravone Dexborneol | Unknown | 37.5 mg | Intravenous |