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Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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.

NCT06315231•Simcere Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 40 years and ≤ 80 years, male or female.
•2. Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
•3. The National Institutes of Stroke Scale score ≤ 20 points.
•4. Time from onset to obtained informed consent form is within 7 days (including 7 days).
•5. Presence of cognitive dysfunction at screening, i.e., MoCA scale score \< 22.
•6. Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.
•7. Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.
•8. female subjects of childbearing potential and male subjects whose female partners are of childbearing potential must be willing to and use contraception during the study treatment and within 30 days after the last dose of study drug and have no plans to donate sperm or eggs; female subjects of childbearing potential will have a negative pregnancy test;
•9. obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.

Exclusion Criteria

•1. Presence of intracranial hemorrhagic disease confirmed by brain imaging.
•2. Severe disturbance of consciousness: NIHSS 1a level of consciousness item score \> 1 point.
•3. Transient ischemic attack (TIA).
•4. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
•5. Poorly controlled diabetes (fasting blood glucose \>10mmol/L and/or HbA1c\>8%).
•6. Patients with contraindications to MRI imaging.
•7. For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
•8. Presence of cognitive dysfunction prior to stroke assessed by informants, that is, the average score of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, 16-item version) during the screening period was ≥ 3.19 and the total score was ≥ 51.
•9. Patients who have been diagnosed with severe mental disorders prior to stroke.
•10. Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.
+11 more criteria

Locations (21)

Taihe County People's Hospital

Fuyang, Anhui, China

Hefei First People's Hospital

Hefei, Anhui, China

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

The Second People's Hospital of Hefei

Hefei, Anhui, China

Huangshan City People's Hospital

Huangshan City, Anhui, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Zhumadian Central Hospital

Zhumadian, Henan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

April 8, 2024

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2026

Last Updated

September 3, 2025

Enrollment

226

ESTIMATED participants

Conditions

Post-stroke Cognitive Impairment

Interventions

Edaravone dexborneol sublingual tablet

DRUG

Placebo

DRUG

Contacts

Chunchen Huang, Doctor

CONTACT

+8618502113382 huangchunchen@simcere.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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