drugset / Trial / NCT06315231

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

NCT06315231

Phase 2 Recruiting 226 enrolled Simcere Pharmaceutical Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-04-08
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Edaravone Dexborneol Unknown Subcutaneous