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

NCT06315231 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-09-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315231 on ClinicalTrials.gov