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

September 1, 2025 updated by: Simcere Pharmaceutical Co., Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of USTC Anhui Provincial Hospital
        • Contact:
      • Hefei, Anhui, China
      • Hefei, Anhui, China
        • Recruiting
        • Hefei First People's Hospital
        • Contact:
      • Huangshan City, Anhui, China
        • Recruiting
        • Huangshan City People's Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
    • Guangxi
      • Wuzhou, Guangxi, China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhumadian, Henan, China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Benxi, Liaoning, China
        • Recruiting
        • Liaoning Health Industry Group Bensteel General Hospital
        • Contact:
      • Dalian, Liaoning, China
        • Recruiting
        • The First Hospital of Dalian Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • The first people's hospital of Shenyang
        • Contact:
    • Shandong
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical College
        • Contact:
      • Liaocheng, Shandong, China
      • Taian, Shandong, China
        • Recruiting
        • Tai'an Central Hospital
        • Contact:
    • Sichuan
      • Suining, Sichuan, China
    • Zhejiang
      • Dongyang, Zhejiang, China
        • Recruiting
        • Dongyang People's Hospital
        • Contact:
      • Huzhou, Zhejiang, China
        • Recruiting
        • The First People's Hospital of Huzhou
        • Contact:
      • Zhuji, Zhejiang, China
        • Recruiting
        • Zhuji People's Hospital of Zhejiang Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. Patients have received the cognitive enhancers and other anti-dementia drugs within 1 month before the screening period, including but not limited to cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and non-competitive N-methyl-D-aspartate (NMDA) receptor antagonists (memantine) and other drugs (such as mannitol sodium capsules, Ginkgo Biloba Extract Injection, Compound Ginkgo Biloba Tablets, oxiracetam, aniracetam, piracetam，nicergoline, Lecanemab, Donanemab, Aducanumab, etc. ).
  12. Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 × ULN.
  13. Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine > 1.5 × ULN.
  14. Thrombectomy or interventional therapy has been applied or planned after this episode.
  15. History of malignancy; except for subjects with non-melanoma skin cancer (NMSC) that has been successfully treated and limited cervical cancer in situ. Subjects with a diagnosis of malignancy after enrollment may continue to participate in the study or not at the discretion of the investigator and at the discretion of the subject;
  16. Suffering from a severe systemic disease with an expected survival period of <1 year;
  17. hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);
  18. pregnancy, lactation, and patients planning pregnancy;
  19. history of major surgery within 4 weeks prior to enrollment;
  20. participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;
  21. in the opinion of the investigator, not suitable for participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of edaravone dexborneol sublingual tablet
Patients will receive edaravone dexborneol sublingual tablet twice daily of 24 weeks.
Drug: Edaravone dexborneol sublingual tablet
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
Placebo Comparator: Placebo
Patients will receive placebo twice daily of 24 weeks.
Drug: Placebo
Patients will receive one placebo twice daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Until follow up 26 weeks or early termination
Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.
Until follow up 26 weeks or early termination
Number of discontinuation/withdrawal patients
Time Frame: Until follow up 26 weeks or early termination
Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.
Until follow up 26 weeks or early termination
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
Time Frame: Until follow up 24 weeks
The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 24 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.
Until follow up 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group
Time Frame: Week 12 and Week 24
The incidence of PSCI in each group at the 12th and 24th week of treatment, defined as Proportion of patients with MoCA score <22
Week 12 and Week 24
The changes of Mini-Mental State Examination (MMSE) score
Time Frame: Week 12 and Week 24
Mini-Mental State Examination (MMSE) at the 12th and 24th week of treatment (MMSE) score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Week 12 and Week 24
The changes of Montreal Cognitive Assessment (MoCA) scale
Time Frame: Week 12 and Week 24
Montreal Cognitive Assessment at the 12th and 24th week of treatment (MoCA) scale score changes from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Week 12 and Week 24
The changes of MoCA subscales
Time Frame: Week 12 and Week 24
MoCA subscales (including visuospatial and execution) at the 12th and 24th week of treatment Function, naming, delayed recall, attention, language, abstraction, Orientation 7 subitems) from baseline. The minimum score is 0 and maximum score is 30 and the higher scores means the better outcome.
Week 12 and Week 24
Modified Rankin Scale (mRS) scores
Time Frame: Week 12 and Week 24
Modified Rankin Scale (mRS) scores at the 12th and 24th week of treatment. The minimum score is 0 and maximum score is 5 and the higher scores means the worse outcome.
Week 12 and Week 24
The changes of National Institutes of Health Stroke Scale
Time Frame: Week 4 , Week 12 and Week 24
National Institutes of Health Stroke Scale at the 4th,12th and 24th weeks of treatment (NIHSS) score changes from baseline. The minimum score is 0 and maximum score is 42 and the higher scores means the worse outcome.
Week 4 , Week 12 and Week 24
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
Time Frame: Week 12
The changes of the scores of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) in each group after 12 weeks of treatment were compared with baseline. The minimum score is 0 and maximum score is 115 and the higher scores means the worse outcome.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simcere Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM0308-02-Y-2-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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