Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
NCT ID: NCT06315231
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
226 participants
INTERVENTIONAL
2024-04-08
2026-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group of edaravone dexborneol sublingual tablet
Patients will receive edaravone dexborneol sublingual tablet twice daily of 24 weeks.
Edaravone dexborneol sublingual tablet
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
Placebo
Patients will receive placebo twice daily of 24 weeks.
Placebo
Patients will receive one placebo twice daily for 24 weeks
Interventions
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Edaravone dexborneol sublingual tablet
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
Placebo
Patients will receive one placebo twice daily for 24 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
No
Sponsors
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Simcere Pharmaceutical Co., Ltd
OTHER
Responsible Party
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Locations
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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
Zhuji People's Hospital of Zhejiang Province
Zhuji, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SIM0308-02-Y-2-201
Identifier Type: -
Identifier Source: org_study_id
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