Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-03-11; most recent amendment 2025-09-01.
Status change: Not Yet Recruiting → Recruiting 2024-06-10
Trial Details
NCT Number NCT06315231
Lead Sponsor Simcere Pharmaceutical Co., Ltd
Conditions Post-stroke Cognitive Impairment
Enrollment 226 participants
Start Date 2024-04-08
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-03