Butylphthalide for thinking and memory problems in older adults with focal epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial enrolling 220 participants aged 60–85 with focal epilepsy and MoCA scores of 18–25. Participants are randomized 1:1 to butylphthalide soft capsules (0.2 g three times daily) or matching placebo for 48 weeks, with stable anti-seizure medications maintained. The primary outcome is change in MoCA total score from baseline to 48 weeks; secondary outcomes include a battery of neuropsychological tests, seizure control measures, activities of daily living, quality of life, and exploratory neurobiological markers. The trial represents off-label testing of a neuroprotective agent previously approved in China for stroke-related indications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Huiqin Xu, MD — Department of Neurology, First Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Huiqin Xu, MD
• Email: xuhuiqin@wmu.edu.cn
• Phone: +86-13858806368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.