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New treatment option for Cerebral Small Vessel Disease
Official title Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
ClinicalTrials.gov ID: NCT06674460
What this study is testing
What is Edaravone Dexborneol Sublingual Tablets?
Edaravone Dexborneol Sublingual Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cerebral small vessel disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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) confirmed by MRI.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- 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...
- 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.
You likely can't join if
- Intracranial Hemorrhagic Diseases: Evidence of hemorrhagic stroke, epidural hematoma, subarachnoid hemorrhage, or other bleeding disorders detected...
- 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...
- 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...
See the full eligibility 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...
- Informed Consent: Participants or their legal representatives must voluntarily sign an informed consent form (ICF). 2\.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.