Cerebral Small Vessel DiseasePhase 3TASTE-SVDNCT06674460
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
A Phase 3 study testing Edaravone Dexborneol Sublingual Tablets in people with Cerebral Small Vessel Disease and Ischemic Stroke, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Disease, Ischemic Stroke
- What is being tested?
- Edaravone Dexborneol Sublingual Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Oct 2028
- Phase
- Phase 3
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- Age: Between 30 and 80 years .
- MRI-confirmed recent small subcortical infarct (RSSI): A lesion in the small penetrating artery territory, detected as DWI hyperintensity and ADC hypointensity, with a maximum axial diameter ≤20 mm.
- White Matter Hyperintensity (WMH) Burden: Fazekas score ≥2 (total score range: 0-6).
- Time from Stroke Onset: ≤3 weeks from symptom onset to randomization.
- Pre-stroke Functional Status: Modified Rankin Scale (mRS) ≤1 before the index stroke.
- Cognitive Function: No prior diagnosis of cognitive impairment or dementia.
- Education Level: At least primary school education and capable of completing cognitive assessments as judged by the investigator.
- Contraception Requirements:Women of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception during the study and 30 days after the last dose of the investigational drug.Female participants must have a negative pregnancy test before enrollment.
- Informed Consent: Participants or their legal representatives must voluntarily sign an informed consent form (ICF).
- Exclusion Criteria:
- Intracranial Hemorrhagic Diseases: Evidence of hemorrhagic stroke, epidural hematoma, subarachnoid hemorrhage, or other bleeding disorders detected by head imaging (MRI/CT).However, hemorrhagic transformation may be assessed by the investigator for potential inclusion.
- Severe Consciousness Disturbance: NIHSS item 1a score >1 (indicative of significant impairment in consciousness).
- Cortical Infarcts or Other Brain Abnormalities:Co-existing cortical infarcts, hydrocephalus, or other non-vascular white matter diseases (e.g., multiple sclerosis, carbon monoxide poisoning-related leukoencephalopathy).
- Severe Carotid Artery Stenosis: Requiring surgical intervention (>50% stenosis).
- Systemic Conditions Affecting Cognition:Endocrine disorders, vitamin deficiencies, systemic autoimmune diseases that can cause cognitive impairment.
- Neurological Disorders Associated with Cognitive Decline:CNS infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, epilepsy, brain tumors, or severe traumatic brain injury.
- Pre-existing Severe Psychiatric Disorders:Diagnosed with major depressive disorder, vascular cognitive impairment, Alzheimer's disease, Parkinson's disease dementia, Lewy body dementia, frontotemporal dementia, or any cognitive dysfunction unrelated to stroke.
- Severe Physical Disability or Language Impairment:Severe hemiplegia or aphasia that significantly affects cognitive assessment.
- Use of Cognitive-Enhancing Medications:Within 4 weeks prior to screening, including but not limited to:Cholinesterase inhibitors (donepezil, rivastigmine, galantamine), NMDA receptor antagonists (memantine),Other neuroprotective agents (sodium oligomannate, lecanemab)
- Severe Liver or Kidney Dysfunction:Active liver disease (acute hepatitis, chronic active hepatitis, cirrhosis) or ALT/AST >2× ULN.
- Severe renal impairment (serum creatinine >1.5× ULN).
- Life Expectancy <1 year due to severe systemic diseases.
- Contraindications to MRI:Participants with MRI-incompatible implants, severe claustrophobia, or inability to undergo MRI.
- Known Allergies:History of hypersensitivity to Dexborneol, natural borneol, edaravone, or any excipients (e.g., mannitol, copovidone, microcrystalline cellulose, silica, magnesium stearate).
- Pregnancy and Lactation:Pregnant or lactating women, or those planning pregnancy during the study period.
- Participation in Other Clinical Trials:Enrolled in another clinical trial within the last 30 days.
- Other Investigator-Determined Factors:Any other medical, psychological, or social condition that, in the investigator's judgment, makes the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Fei Han, 8615101131416, lourahan@163.com
About this study
Official title: Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease: A Randomized, Double-Blind, Placebo-Controlled Study
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) and concomitant moderate-to-severe white matter hyperintensities (WMH) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period.
Read more
The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score.
Secondary endpoints include additional functional and cognitive assessments at week 24. Safety assessments will include all-cause mortality, adverse event (AE), treatment-related adverse event (TRAE), and serious adverse event (SAE).
The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.
Read the detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
- Background and Rationale Cerebral small vessel disease (CSVD) is a major contributor to stroke, cognitive decline, and disability. Currently, there are no approved targeted therapies specifically addressing the pathophysiology of CSVD-related ischemic stroke. Edaravone Dexborneol, a novel free radical scavenger and anti-inflammatory agent, has shown neuroprotective effects in preclinical models and clinical trials for ischemic stroke. The TASTE-SL trial demonstrated that Edaravone Dexborneol improved functional outcomes at 90 days in acute ischemic stroke patients.
- Study Design and Methods A total of 600 participants will be recruited across 50 clinical sites in China. Participants must be 30-80 years old and have an MRI-confirmed recent small subcortical infarct (RSSI) and concomitant moderate-to-severe white matter hyperintensities (WMH). Eligible participants will be randomized 1:1 into:
- Treatment group: Edaravone Dexborneol Sublingual Tablets (Edaravone 30 mg + Dexborneol 6 mg), twice daily for 24 weeks.
- Control group: Placebo, twice daily for 24 weeks.
- Study Endpoints 3.1 Primary Efficacy Endpoint
A hierarchical composite endpoint including:
- All-cause mortality
- Modified Rankin Scale (mRS) score ≥2
- Recurrent stroke
- Change in MoCA score from baseline
- Change in VaDAS-Cog score from baseline
3.2 Secondary Efficacy Endpoints
- Hierarchical composite endpoint: all-cause mortality, mRS≥2, or recurrent stroke
- All-cause mortality
- Functional disability, defined as a mRS≥2
- Recurrent stroke
- Proportion of patients with post-stroke cognitive impairment, defined as a MoCA score <22
- Change in Mini-Mental State Examination (MMSE) score from baseline
- Change in MoCA score from baseline
- Change in VaDAS-Cog score from baseline
- Change in Hamilton Depression Scale score from baseline
- Change in IADL score from baseline
3.3 Safety Endpoints
- Serious adverse event (SAE)
- All-cause mortality
- Adverse event (AE)
- Treatment-related adverse event (TRAE)
- Statistical Analysis The primary analysis will use the Win Ratio method to compare hierarchical composite endpoints between treatment groups. Secondary analyses will assess prespecified clinical, cognitive, and safety outcomes using methods tailored to their data types, including the win ratio, modified Poisson regression, mixed-effects models, linear regression, Kaplan-Meier and Cox models, and Poisson regression.
- Significance This study aims to determine whether Edaravone Dexborneol Sublingual Tablets can improve functional outcomes, prevent cognitive decline, and reduce stroke recurrence in CSVD-related ischemic stroke. If successful, the findings may support a new treatment approach for this high-risk population.
- Conditions
- Cerebral Small Vessel Disease, Ischemic Stroke
- Being tested
- Edaravone Dexborneol Sublingual Tablets, Placebo
- Keywords
- sublingual edaravone dexborneol, cerebral small vessel disease, acute ischemic cerebral small vessel disease, cognition
- Medical subject headings
- Cerebral Small Vessel Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone Dexborneol Sublingual TabletsDrug
One tablet of Edaravone Dexborneol Sublingual Tablet (containing 30mg Edaravone and 6mg Dexborneol) to be taken sublingually, twice daily.
PlaceboDrug
One placebo tablet, to be taken sublingually, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Edaravone Dexborneol Sublingual Tablets | Experimental | One tablet of Edaravone Dexborneol Sublingual Tablet (containing 30mg Edaravone and 6mg Dexborneol) to be taken sublingually, twice daily. Receives: Drug: Edaravone Dexborneol Sublingual Tablets |
| Placebo | Placebo comparator | One placebo tablet, to be taken sublingually, twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite Endpoint
This composite outcome consists of five hierarchical endpoints at 24 weeks, analyzed using the Win Ratio method:
- All-Cause Mortality
- Modified Rankin Scale (mRS) Score ≥2
- Stroke Recurrence
- Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
- Change in Vascular Dementia Assessment Scale-Cognitive Subscale (VaDAS-Cog) Score from Baseline.
The Win Ratio approach will be used to analyze these outcomes in order of priority.
Measured: 24 weeks
Secondary outcomes (13)
Hierarchical composite endpoint
Hierarchical composite endpoint comprising all-cause mortality, mRS ≥2, and stroke recurrence.The hierarchy of composite endpoint of all-cause mortality, mRS≥2, recurrent stroke at 24 weeks will be analysed using a win ratio method.
Measured: 24 weeks
All cause mortality
The number of participants who experience all-cause mortality at 24 weeks. All-cause mortality includes death from any reason, such as cardiovascular, neurological, or other systemic causes. This measure is used to assess the overall survival impact of the intervention.
Measured: 24 weeks
Modified Rankin Scale (mRS) Score ≥2
The proportion of participants with a modified Rankin Scale (mRS) score ≥2 at 24 weeks. The mRS is a widely used functional outcome measure that assesses the degree of disability or dependence in daily activities following a stroke. The scale ranges from 0 (no symptoms) to 6 (death), with scores of 2 or higher indicating functional dependence. A higher proportion of participants with mRS ≥2 suggests a worse functional outcome.
Measured: 24 weeks
Stroke recurrence
The number of participants who experience a recurrent stroke within 24 weeks of treatment. Recurrent stroke is defined as a new ischemic or hemorrhagic stroke occurring after the initial qualifying event, confirmed by neurological symptoms lasting ≥24 hours and neuroimaging evidence (MRI or CT). This measure assesses the effectiveness of the intervention in preventing subsequent strokes
Measured: 24 weeks
Post-stroke cognitive impairment
Number of participants with post-stroke cognitive impairment, defined as a MOCA score < 22
Measured: 24 weeks
Cognitive function (MMSE)
Changes in Mini-Mental State Examination (MMSE) score from baseline. MMSE includes the assessment of 11 cognitive functions, which encompass orientation, registration of information, attention/calculation abilities, recall, naming, repetition, comprehension (both verbal and written), writing, and visuospatial construction skills. The MMSE scale ranges from 0 to 30 points, with higher scores indicating a better outcome.
Measured: 24 weeks
Cognitive function (MoCA)
The change in Montreal Cognitive Assessment (MoCA) scores from baseline to 24 weeks of treatment. The MoCA is a cognitive screening tool that assesses multiple domains, including attention, concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function. A greater positive change from baseline represents an improvement in cognitive function.
Measured: 24 weeks
Cognitive function (VaDAS-Cog)
Changes in Vascular Dementia Assessment Scale-Cognitive (VaDAS-Cog) score from baseline. The VaDAS-Cog is a neuropsychological assessment tool specifically designed to evaluate cognitive impairments associated with vascular dementia. VaDAS-Cog was created by adding five subtests to the ADAS-Cog that reflect attention and executive functions. The total score ranges from 0 to 70, with lower scores indicating lesser severity.
Measured: 24 weeks
Depression (HAMD)
Changes in Hamilton Depression Rating Scale (HAMD) score from baseline. The HAMD is a widely used clinical tool for assessing the severity of depression. It consists of multiple items that evaluate various aspects of depressive symptoms, including mood, guilt, suicidal ideation, work and interest, among others. It is scored on a scale from 0 to 52, with higher scores indicating more severe symptoms.
Measured: 24 weeks
Activity of Daily Living
Changes in Instrumental Activities of Daily Living (IADL) score from baseline.IADL are activities that support daily life and are oriented toward interacting with your environment. Common IADLs include: Care of others; Care of pets; Child rearing; Communication management; Driving and community mobility; Financial management; Health management and maintenance; Home establishment and management; Meal preparation and clean up; Religious and spiritual activities and expressions; Safety procedure and emergency responses; Shopping. It is scored on a scale from 0 to 31, with higher scores indicating more severe symptoms.
Measured: 24 weeks
Serious adverse events
Serious adverse events, confirmed by the Clinical Event Committee.
Measured: 24 weeks
Adverse events
Adverse events, confirmed by the Clinical Event Committee.
Measured: 24 weeks
Treatment-related adverse events
Treatment-related adverse events, confirmed by the Clinical Event Committee.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Aug 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674460
- Sponsor's protocol ID
- TASTE-SVD
- Other IDs
- 2023ZD0504900
- Acronym
- TASTE-SVD
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
PubMed 38372981Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.
PubMed 31709115Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
PubMed 33588596
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease: A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06674460
- Acronym / sponsor ID
- TASTE-SVD / TASTE-SVD
- Conditions
- Cerebral Small Vessel Disease, Ischemic Stroke
- Keywords
- sublingual edaravone dexborneol, cerebral small vessel disease, acute ischemic cerebral small vessel disease, cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 5 Nov 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 study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) and concomitant moderate-to-severe white matter hyperintensities (WMH) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period.
The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score.
Secondary endpoints include additional functional and cognitive assessments at week 24. Safety assessments will include all-cause mortality, adverse event (AE), treatment-related adverse event (TRAE), and serious adverse event (SAE).
The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.
Detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
- Background and Rationale Cerebral small vessel disease (CSVD) is a major contributor to stroke, cognitive decline, and disability. Currently, there are no approved targeted therapies specifically addressing the pathophysiology of CSVD-related ischemic stroke. Edaravone Dexborneol, a novel free radical scavenger and anti-inflammatory agent, has shown neuroprotective effects in preclinical models and clinical trials for ischemic stroke. The TASTE-SL trial demonstrated that Edaravone Dexborneol improved functional outcomes at 90 days in acute ischemic stroke patients.
- Study Design and Methods A total of 600 participants will be recruited across 50 clinical sites in China. Participants must be 30-80 years old and have an MRI-confirmed recent small subcortical infarct (RSSI) and concomitant moderate-to-severe white matter hyperintensities (WMH). Eligible participants will be randomized 1:1 into:
- Treatment group: Edaravone Dexborneol Sublingual Tablets (Edaravone 30 mg + Dexborneol 6 mg), twice daily for 24 weeks.
- Control group: Placebo, twice daily for 24 weeks.
- Study Endpoints 3.1 Primary Efficacy Endpoint
A hierarchical composite endpoint including:
- All-cause mortality
- Modified Rankin Scale (mRS) score ≥2
- Recurrent stroke
- Change in MoCA score from baseline
- Change in VaDAS-Cog score from baseline
3.2 Secondary Efficacy Endpoints
- Hierarchical composite endpoint: all-cause mortality, mRS≥2, or recurrent stroke
- All-cause mortality
- Functional disability, defined as a mRS≥2
- Recurrent stroke
- Proportion of patients with post-stroke cognitive impairment, defined as a MoCA score <22
- Change in Mini-Mental State Examination (MMSE) score from baseline
- Change in MoCA score from baseline
- Change in VaDAS-Cog score from baseline
- Change in Hamilton Depression Scale score from baseline
- Change in IADL score from baseline
3.3 Safety Endpoints
- Serious adverse event (SAE)
- All-cause mortality
- Adverse event (AE)
- Treatment-related adverse event (TRAE)
- Statistical Analysis The primary analysis will use the Win Ratio method to compare hierarchical composite endpoints between treatment groups. Secondary analyses will assess prespecified clinical, cognitive, and safety outcomes using methods tailored to their data types, including the win ratio, modified Poisson regression, mixed-effects models, linear regression, Kaplan-Meier and Cox models, and Poisson regression.
- Significance This study aims to determine whether Edaravone Dexborneol Sublingual Tablets can improve functional outcomes, prevent cognitive decline, and reduce stroke recurrence in CSVD-related ischemic stroke. If successful, the findings may support a new treatment approach for this high-risk population.
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 |
|---|---|---|
| Edaravone Dexborneol Sublingual Tablets | Experimental | Drug: Edaravone Dexborneol Sublingual TabletsOne tablet of Edaravone Dexborneol Sublingual Tablet (containing 30mg Edaravone and 6mg Dexborneol) to be taken sublingually, twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboOne placebo tablet, to be taken sublingually, twice daily. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 TabletsOne tablet of Edaravone Dexborneol Sublingual Tablet (containing 30mg Edaravone and 6mg Dexborneol) to be taken sublingually, twice daily. | Drug | Edaravone Dexborneol Sublingual Tablets |
| PlaceboOne placebo tablet, to be taken sublingually, twice daily | Drug | Placebo |
Primary outcome
Hierarchical Composite Endpoint
Time frame: 24 weeks
This composite outcome consists of five hierarchical endpoints at 24 weeks, analyzed using the Win Ratio method: 1. All-Cause Mortality 2. Modified Rankin Scale (mRS) Score ≥2 3. Stroke Recurrence 4. Change in Montreal Cognitive Assessment (MoCA) Score from Baseline 5. Change in Vascular Dementia Assessment Scale-Cognitive Subscale (VaDAS-Cog) Score from Baseline. The Win Ratio approach will be used to analyze these outcomes in order of priority.
13 secondary outcomes
Hierarchical composite endpoint
Time frame: 24 weeks
All cause mortality
Time frame: 24 weeks
Modified Rankin Scale (mRS) Score ≥2
Time frame: 24 weeks
Stroke recurrence
Time frame: 24 weeks
Post-stroke cognitive impairment
Time frame: 24 weeks
Cognitive function (MMSE)
Time frame: 24 weeks
Cognitive function (MoCA)
Time frame: 24 weeks
Cognitive function (VaDAS-Cog)
Time frame: 24 weeks
Depression (HAMD)
Time frame: 24 weeks
Activity of Daily Living
Time frame: 24 weeks
Serious adverse events
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Treatment-related adverse events
Time frame: 24 weeks
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 29 Oct 2026.
- Results publication: PubMed 38372981Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
- Results publication: PubMed 31709115Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.
- Results publication: PubMed 33588596Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Edaravone Dexborneol Sublingual Tablets in people with Cerebral Small Vessel Disease and Ischemic Stroke, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 YiCheng Zhu, Doctor ((+86)01069156380, zhuych910@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Endpoint (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674460, which also lists 3 linked publications.
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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.