Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Edaravone Dexborneol Sublingual Tablets for patients who have had an acute ischemic stroke caused by small vessel disease. The trial aims to find out if this treatment can help improve recovery and brain function in people who have experienced a specific type of stroke known as a recent small subcortical infarct. Researchers will enroll about 600 participants, aged 30 to 80 years, and will randomly assign them to receive either the study medication or a placebo (a harmless pill with no active ingredients) for 24 weeks. After the treatment period, participants will be followed for an additional 28 weeks to assess their progress.

To be eligible for the trial, participants must be between 30 and 80 years old and have had a stroke confirmed by an MRI scan within the last three weeks. They should also have good pre-stroke function and no history of significant cognitive impairment. Participants can expect to complete various assessments to measure their health and cognitive abilities throughout the study. It's important to note that certain medical conditions and treatments may exclude someone from participating. Overall, this trial is an important step in exploring new options for improving recovery after strokes related to small vessel disease.

Gender

ALL

Eligibility criteria

• 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.