NCT06315231

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients

Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, exploratory Phase II clinical trial. The goal of this clinical trial is to assess the safety and efficacy of edaravone dexborneol sublingual tablets for post-stroke cognitive impairment in patients with acute ischemic stroke. Participants will be required to receive 24 weeks treatment of edaravone dexborneol sublingual tablets or placebo during this study. The safety and efficacy endpoints will be compared in the patients with edaravone dexborneol sublingual tablets or placebo.

Conditions

• Post-stroke Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Edaravone dexborneol sublingual tablet	Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
DRUG	Placebo	Patients will receive one placebo twice daily for 24 weeks

Timeline

• Start date: 2024-04-08
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-03-18
• Last updated: 2025-09-03

Locations

21 sites across 1 country: China