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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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.

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (NCT06315231) is a Phase 2 interventional studying Post-stroke Cognitive Impairment, sponsored by Simcere Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Post-stroke Cognitive Impairment and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 226 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Post-stroke Cognitive Impairment subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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 willing to sign a consent form from the patient or his/her legal representative approved by the Ethics Committee. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Health Industry Group Bensteel General Hospital
Benxi, Liaoning, China
The First Hospital of Dalian Medical University
Dalian, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Tai'an Central Hospital
Taian, Shandong, China
Suining Central Hospital
Suining, Sichuan, China
Dongyang People's Hospital
Dongyang, Zhejiang, China
The First People's Hospital of Huzhou
Huzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06315231), the sponsor (Simcere Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06315231 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06315231?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06315231?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06315231. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06315231. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.