Status:
RECRUITING
Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Taizhou Hospital
Lishui Country People's Hospital
Conditions:
Focal Epilepsy
Cognitive Impairment
Eligibility:
All Genders
60-85 years
Phase:
PHASE4
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of butylphthalide soft capsules for treating cognitive impairment in elderly patients with ...
Detailed Description
Background and Rationale: Epilepsy affects approximately 9 million people in China, with focal epilepsy comprising 60-70% of adult cases. Cognitive impairment occurs in 40-60% of elderly patients wit...
Eligibility Criteria
Inclusion
- Age 60-85 years (inclusive)
- Diagnosed with focal epilepsy according to ILAE 2025 latest classification standards, with disease duration ≥2 years
- Currently receiving stable anti-seizure medication (ASM) treatment for ≥3 months, with good seizure control (monthly seizure frequency ≤4 times in the past 3 months)
- Cognitive impairment: Montreal Cognitive Assessment (MoCA) score 18-25 points (inclusive)
- Basic Chinese language comprehension and expression ability, able to cooperate with neuropsychological testing
- Voluntary participation and signed informed consent
Exclusion
- Diagnosed with various types of dementia (including Alzheimer's disease, vascular dementia, etc.)
- Clear history of stroke with corresponding lesions on neuroimaging, or severe white matter lesions on brain MRI
- Other neurological diseases that may cause cognitive impairment (traumatic brain injury, encephalitis, hydrocephalus, etc.)
- Systemic diseases that may cause cognitive impairment (severe cardiac, hepatic, renal dysfunction, endocrine diseases, etc.)
- Current severe depression or other psychiatric diseases affecting cognitive assessment
- History of alcohol dependence, drug abuse, or other substance use affecting cognitive function
- Allergy to butylphthalide or its excipients
- Participation in other drug clinical trials within 30 days
- Other conditions deemed inappropriate for participation by investigators
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07193277
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 25 2025
Active Locations (1)
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1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000