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Could a simple tablet protect your brain after a stroke?

NCT ID NCT06315231

Disease control Sponsor: Simcere Pharmaceutical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a sublingual tablet called edaravone dexborneol can help prevent or reduce thinking problems that often occur after a stroke. About 226 people who recently had a stroke and already show some cognitive issues will take the tablet or a placebo twice daily for 24 weeks. Researchers will measure side effects and changes in thinking skills to see if the drug is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
edaravone dexborneol sublingual tablet
What this could lead to
If it works, this could lead to a new treatment to reduce cognitive decline after a stroke, helping people think more clearly.
What could go wrong
This is an early Phase II trial with only 226 people, so results may not apply to everyone. The drug may not improve cognition more than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post-stroke cognitive impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical College

    RECRUITING

    Jining, Shandong, China

  • Dongyang People's Hospital

    RECRUITING

    Dongyang, Zhejiang, China

  • Hefei First People's Hospital

    RECRUITING

    Hefei, Anhui, China

  • Huangshan City People's Hospital

    RECRUITING

    Huangshan City, Anhui, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, China

  • Liaoning Health Industry Group Bensteel General Hospital

    RECRUITING

    Benxi, Liaoning, China

  • Suining Central Hospital

    RECRUITING

    Suining, Sichuan, China

  • Tai'an Central Hospital

    RECRUITING

    Taian, Shandong, China

  • Taihe County People's Hospital

    RECRUITING

    Fuyang, Anhui, China

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, China

  • The First Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • The First People's Hospital of Huzhou

    RECRUITING

    Huzhou, Zhejiang, China

  • The First People's Hospital of Shenyang

    RECRUITING

    Shenyang, Liaoning, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second People's Hospital of Hefei

    RECRUITING

    Hefei, Anhui, China

  • Wuzhou Red Cross Hospital

    RECRUITING

    Wuzhou, Guangxi, China

  • Zhuji People's Hospital of Zhejiang Province

    RECRUITING

    Zhuji, Zhejiang, China

  • Zhumadian Central Hospital

    RECRUITING

    Zhumadian, Henan, China

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