NCT06645522

Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke

Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Yi Yang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Detailed description

In this study, 1200 patients with acute ischemic stroke within 48 hours from the onset are included in several centres in China according to the principles of randomization, double-blind, and parallel control. The experimental group receives basic treatment and edaravone dexborneol injection for 7 consecutive days, and sequentially receives a sublingual dose of edaravone dexborneol for 21 consecutive days. The placebo group receives basic treatment and edaravone dexborneol placebo injection for 7 consecutive days and sequentially receives a sublingual dose of edaravone dexborneol placebo drug for 21 consecutive days. Two groups will be followed up at day 90 to evaluate the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Edaravone dexborneol	Edaravone dexborneol injection 37.5mg (edaravone 30mg and dexborneol 7.5mg) and 100ml of 0.9% saline every 12 hours for 7 days; sequentially a sublingual dose of edaravone dexborneol 36 mg (edaravone, 30 mg; dexborneol, 6 mg) twice a day for 21 days.
DRUG	Placebo	Placebo injection every 12 hours for 7 days; sequentially a sublingual dose of placebo drug twice a day for 21 days.

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-10-30
• Completion: 2027-01-30
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: China