You are here

  • Home
  • Archive
  • Volume 4, Issue 3
  • 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

Article Text

Article menu

Download PDFPDF

Original article
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
  1. Jie Xu1,2,
  2. Yilong Wang1,2,
  3. Anxin Wang1,2,
  4. Zhiqiang Gao3,
  5. Xiaoping Gao4,
  6. Huisheng Chen5,
  7. Junshan Zhou6,
  8. Xingquan Zhao1,2,
  9. Yongjun Wang1,2
  1. 1 Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  2. 2 China National Clinical Research Center for Neurological Diseases, Beijing, China
  3. 3 Department of Neurology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China
  4. 4 Department of Neurology, The First Affiliated Hospital of Hunan Normal University, Changsha, China
  5. 5 Department of Neurology, General Hospital, PLA Shenyang Military Region, Shenyang, China
  6. 6 Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
  1. Correspondence to Prof. Xingquan Zhao; zxq{at}vip.163.com and Professor Yongjun Wang; yongjunwang{at}ncrcnd.org.cn

Abstract

Background Edaravone Dexborneol is a novel neuroprotective agent that comprised edaravone and (+)-borneol, a food additive with an anti-inflammatory effect in animal ischaemic stroke models. This study aims to assess the safety and efficacy of Edaravone Dexborneol compared with edaravone in treating patients with acute ischaemic stroke (AIS).

Methods In this multicentre, randomised, double-blind, multiple-dose, active-controlled, phase II clinical trial, patients with AIS within 48 hours after stroke onset were randomly assigned (1:1:1:1) to low-dose (12.5 mg), medium-dose (37.5 mg) or high-dose (62.5 mg) Edaravone Dexborneol groups, and an active control group with edaravone (30 mg) by 30 min intravenous infusion every 12 hours, for 14 consecutive days. The primary efficacy outcome was the proportion of modified Rankin Scale (mRS)score ≤1 at 90 days and National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 14 days after randomisation. The safety outcome included any adverse event during 90 days after treatment.

Results Of 385 patients included in the efficacy analysis, 94 were randomised to low-dose group, 97 to medium-dose group, 98 to high-dose group and 96 to the control group. No significant difference was observed among the four groups on mRS score (mRS ≤1, p=0.4054) at 90 days or NIHSS score change at 14 days (p=0.6799). However, a numerically higher percentage of patients with mRSscore ≤1 at 90 days in the medium-dose (69.39%) and high-dose (65.63%) groups was observed than in the control group (60.64%). No significant difference in severe adverse events was found among the four groups (p=0.3815).

Conclusions Compared with edaravone alone, Edaravone Dexborneol was safe and well tolerated at all doses, although no significant improvement in functional outcomes was observed at 90days.

Trial registration number NCT01929096.

  • compound edaravone
  • ischemic stroke
  • neuroprotection
  • edaravone

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/svn-2018-000221

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • JX and YW contributed equally.

    • Contributors YoW had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. JX and YiW contributed equally to this work. Study concept and design: YoW. Supplying patients: XZ, YiW, ZG, XG, HC and JZ. Drafting of the manuscript: JX and YiW. Critical revision of the manuscript for important intellectual content: XZ and YiW. Statistical analysis: AW. Study supervision: YoW.

    • Funding Simcere Pharmaceutical Group supported the present study.

    • Competing interests None declared.

    • Ethics approval The study was approved by the institutional review board of each study centre and was conducted in accordance with the principles of the Declaration of Helsinki.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Correction notice This article has been corrected since it first published. The chemical name of the medicine ’compound edaravone‘ has been changed to ’edaravone dexborneol' throughout the article.

    • Patient consent for publication Parental/guardian consent obtained.