New stroke pill aims to boost brain recovery and prevent second strokes
NCT ID NCT06674460
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a sublingual tablet (edaravone dexborneol) can improve outcomes for people who recently had a stroke due to small vessel disease. About 600 adults aged 30–80 will receive either the tablet or a placebo for 24 weeks, with follow-up for one year. The goal is to see if the treatment reduces disability, prevents another stroke, and helps preserve thinking and memory.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
1\. Inclusion Criteria: 1. Age: Between 30 and 80 years . 2. 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. 3. White Matter Hyperintensity (WMH) Burden: Fazekas score ≥2 (total score range: 0-6). 4. Time from Stroke Onset: ≤3 weeks from symptom onset to randomization. 5. Pre-stroke Functional Status: Modified Rankin Scale (mRS) ≤1 before the index stroke. 6. Cognitive Function: No prior diagnosis of cognitive impairment or dementia. 7. Education Level: At least primary school education and capable of completing cognitive assessments as judged by the investigator. 8. 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. 9. Informed Consent: Participants or their legal representatives must voluntarily sign an informed consent form (ICF). 2\. Exclusion Criteria: 1. 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. 2. Severe Consciousness Disturbance: NIHSS item 1a score \>1 (indicative of significant impairment in consciousness). 3. 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). 4. Severe Carotid Artery Stenosis: Requiring surgical intervention (\>50% stenosis). 5. Systemic Conditions Affecting Cognition:Endocrine disorders, vitamin deficiencies, systemic autoimmune diseases that can cause cognitive impairment. 6. Neurological Disorders Associated with Cognitive Decline:CNS infections, Creutzfeldt-Jakob disease, primary Parkinson's disease, epilepsy, brain tumors, or severe traumatic brain injury. 7. 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. 8. Severe Physical Disability or Language Impairment:Severe hemiplegia or aphasia that significantly affects cognitive assessment. 9. 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) 10. Severe Liver or Kidney Dysfunction:Active liver disease (acute hepatitis, chronic active hepatitis, cirrhosis) or ALT/AST \>2× ULN. 11. Severe renal impairment (serum creatinine \>1.5× ULN). 12. Life Expectancy \<1 year due to severe systemic diseases. 13. Contraindications to MRI:Participants with MRI-incompatible implants, severe claustrophobia, or inability to undergo MRI. 14. Known Allergies:History of hypersensitivity to Dexborneol, natural borneol, edaravone, or any excipients (e.g., mannitol, copovidone, microcrystalline cellulose, silica, magnesium stearate). 15. Pregnancy and Lactation:Pregnant or lactating women, or those planning pregnancy during the study period. 16. Participation in Other Clinical Trials:Enrolled in another clinical trial within the last 30 days. 17. Other Investigator-Determined Factors:Any other medical, psychological, or social condition that, in the investigator's judgment, makes the patient unsuitable for participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking Union Medical College Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke