Post-stroke Cognitive ImpairmentPhase 2NCT06315231
Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
A Phase 2 study testing Edaravone dexborneol sublingual tablet in people with Post-stroke Cognitive Impairment, run by Simcere Pharmaceutical Co., Ltd at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Post-stroke Cognitive Impairment
- What is being tested?
- Edaravone dexborneol sublingual tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 21 sitesChina
- Study dates
- 8 Apr 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years and ≤ 80 years, male or female.
- Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
- The National Institutes of Stroke Scale score ≤ 20 points.
- Time from onset to obtained informed consent form is within 7 days (including 7 days).
- Presence of cognitive dysfunction at screening, i.e., MoCA scale score < 22.
- Patients with good cognitive function prior to stroke, without significant cognitive dysfunction and dementia.
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- Education level: primary school or above, and can complete the cognitive function test required per investigator's judgement.
- 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;
- obtain voluntary signed informed consent from the patient or his/her legal representative approved by the Ethics Committee.
Who cannot join
- Presence of intracranial hemorrhagic disease confirmed by brain imaging.
- Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1 point.
- Transient ischemic attack (TIA).
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
- Poorly controlled diabetes (fasting blood glucose >10mmol/L and/or HbA1c>8%).
- Patients with contraindications to MRI imaging.
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- For subjects who are scheduled to undergo EEG examination, Patients with contraindications for EEG examination.
- 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.
- Patients who have been diagnosed with severe mental disorders prior to stroke.
- Severe limb hemiplegia and aphasia and significantly affect cognitive function assessment.
- 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. ).
- Have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0 × ULN.
- Has been diagnosed with severe active kidney disease, renal insufficiency; or serum creatinine > 1.5 × ULN.
- Thrombectomy or interventional therapy has been applied or planned after this episode.
- 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;
- Suffering from a severe systemic disease with an expected survival period of <1 year;
- hypersensitivity to dextran camphene, natural ice chips or edaravone or excipients (mannitol, copovidone, microcrystalline cellulose, cross-linked povidone, silicon dioxide, magnesium stearate);
- pregnancy, lactation, and patients planning pregnancy;
- history of major surgery within 4 weeks prior to enrollment;
- participation in another clinical study within 30 days prior to randomization, or ongoing participation in another clinical study;
- in the opinion of the investigator, not suitable for participation in this clinical study.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
China21 sites, 21 recruiting
- Recruiting
Liaoning Health Industry Group Bensteel General Hospital
Benxi, Liaoning
Zhang Yutao, lnbxzyt@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Li Sun, sunli99@jlu.edu.cn
- Recruiting
The First Hospital of Dalian Medical University
Dalian, Liaoning
Liang Zhanhua, zhanhualiang@163.com
- Recruiting
Dongyang People's Hospital
Dongyang, Zhejiang
Xu Dongjuan, xdj0108@128.com
- Recruiting
Taihe County People's Hospital
Fuyang, Anhui
Zhao Shuguang, Shuguang6139@163.com
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Liu Jun, docliujun@126.com
- Recruiting
Hefei First People's Hospital
Hefei, Anhui
Xi Chunhua, xch3149@126.com
- Recruiting
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui
Jiong Shi, Doctor, Jshi2022@ustc.edu.cn
- Recruiting
The Second People's Hospital of Hefei
Hefei, Anhui
Wu Juncang, Wujuncang126@126.com
- Recruiting
Huangshan City People's Hospital
Huangshan City, Anhui
Ni Chuyuan, hssjnk2013@163.com
- Recruiting
The First People's Hospital of Huzhou
Huzhou, Zhejiang
Ru Sun, Doctor, sunjin2010@tom.com
- Recruiting
Affiliated Hospital of Jining Medical College
Jining, Shandong
Wang Yuzhong, Wangyuzhong_ni@163.com
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Guo Dong, guodonglc@126.com
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Tu Jianglong, tujianglong85@126.com
- Recruiting
The First People's Hospital of Shenyang
Shenyang, Liaoning
Sui Yi, tjyiia@hotmail.com
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Dong Mei, dm-mp@126.com
- Recruiting
Suining Central Hospital
Suining, Sichuan
Xu Lei, 182439789@qq.com
- Recruiting
Tai'an Central Hospital
Taian, Shandong
Liu Yunlin, bb0538@126.com
- Recruiting
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
Chen Xun, 9569819332@qq.com
- Recruiting
Zhuji People's Hospital of Zhejiang Province
Zhuji, Zhejiang
He Yuping, Heywp3456@sina.com
- Recruiting
Zhumadian Central Hospital
Zhumadian, Henan
Gao Ligong, 13703961919@qq.com
About this study
Official title: 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.
- Conditions
- Post-stroke Cognitive Impairment
- Being tested
- Edaravone dexborneol sublingual tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone dexborneol sublingual tabletDrug
Patients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks
PlaceboDrug
Patients will receive one placebo twice daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group of edaravone dexborneol sublingual tablet | Experimental | Patients will receive edaravone dexborneol sublingual tablet twice daily of 24 weeks. Receives: Drug: Edaravone dexborneol sublingual tablet |
| Placebo | Placebo comparator | Patients will receive placebo twice daily of 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events (AE), treatment-related adverse events (TRAE), serious adverse events (SAE) in each group.
Measured: Until follow up 26 weeks or early termination
Number of discontinuation/withdrawal patients
Discontinuation/withdrawal of patients in each group, including discontinuation due to adverse events.
Measured: Until follow up 26 weeks or early termination
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
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.
Measured: Until follow up 24 weeks
Secondary outcomes (7)
The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group
The incidence of PSCI in each group at the 12th and 24th week of treatment, defined as Proportion of patients with MoCA score <22
Measured: Week 12 and Week 24
The changes of Mini-Mental State Examination (MMSE) score
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.
Measured: Week 12 and Week 24
The changes of Montreal Cognitive Assessment (MoCA) scale
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.
Measured: Week 12 and Week 24
The changes of MoCA subscales
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.
Measured: Week 12 and Week 24
Modified Rankin Scale (mRS) scores
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.
Measured: Week 12 and Week 24
The changes of National Institutes of Health Stroke Scale
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.
Measured: Week 4 , Week 12 and Week 24
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start8 Apr 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315231
- Sponsor's protocol ID
- SIM0308-02-Y-2-201
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06315231
- Acronym / sponsor ID
- SIM0308-02-Y-2-201
- Conditions
- Post-stroke Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of edaravone dexborneol sublingual tablet | Experimental | Drug: Edaravone dexborneol sublingual tabletPatients will receive edaravone dexborneol sublingual tablet twice daily of 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo twice daily of 24 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 40 years and ≤ 80 years, male or female.
- Diagnosed as ischemic stroke, no significant pre-stroke functional disability (mRS score ≤ 1prior to stroke onset).
- The National Institutes of Stroke Scale score ≤ 20 points.
- Time from onset to obtained informed consent form is within 7 days (including 7 days).
- Presence of cognitive dysfunction at screening, i.e., MoCA scale score < 22.
Key exclusion criteria (21 listed)
- Presence of intracranial hemorrhagic disease confirmed by brain imaging.
- Severe disturbance of consciousness: NIHSS 1a level of consciousness item score > 1 point.
- Transient ischemic attack (TIA).
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control.
- Poorly controlled diabetes (fasting blood glucose >10mmol/L and/or HbA1c>8%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edaravone dexborneol sublingual tabletPatients will receive one edaravone dexborneol sublingual tablet twice daily for 24 weeks | Drug | Group of edaravone dexborneol sublingual tablet |
| PlaceboPatients will receive one placebo twice daily for 24 weeks | Drug | Placebo |
Primary outcome
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.
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.
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.
7 secondary outcomes
The incidence of Post Stroke Cognitive Impairment（PSCI ）in each group
Time frame: Week 12 and Week 24
The changes of Mini-Mental State Examination (MMSE) score
Time frame: Week 12 and Week 24
The changes of Montreal Cognitive Assessment (MoCA) scale
Time frame: Week 12 and Week 24
The changes of MoCA subscales
Time frame: Week 12 and Week 24
Modified Rankin Scale (mRS) scores
Time frame: Week 12 and Week 24
The changes of National Institutes of Health Stroke Scale
Time frame: Week 4 , Week 12 and Week 24
The changes of the Vascular Dementia Assessment Scale-cognitive subscale (VaDAS-Cog) scores.
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edaravone dexborneol sublingual tablet in people with Post-stroke Cognitive Impairment, run by Simcere Pharmaceutical Co., Ltd at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunchen Huang, Doctor (+8618502113382, huangchunchen@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Until follow up 26 weeks or early termination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.