Compound Edaravone Injection for Acute Ischemic Stroke

Summary

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients; 2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.

Timeline

Start

2013-08

Primary completion

2014-12

Completion

2015-02

Outcome

Missed primary endpoint

paper No significant difference was observed among the four groups on mRS score (mRS ≤1, p=0.4054) PMID 31709115 ↗

paper or NIHSS score change at 14 days (p=0.6799). PMID 31709115 ↗

paper although no significant improvement in functional outcomes was observed at 90days. PMID 31709115 ↗

Publications

• Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Edaravone	Unknown	30 mg	Intravenous
Subject	Edaravone Dexborneol	Unknown	12.5 mg	Intravenous
Subject	Edaravone Dexborneol	Unknown	37.5 mg	Intravenous
Subject	Edaravone Dexborneol	Unknown	62.5 mg	Intravenous

Indications