Butylphthalide for thinking and memory problems in older adults with focal epilepsy
Safety and Efficacy of Butylphthalide Soft Capsules for Cognitive Impairment Comorbid With Focal Epilepsy in Elderly Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
This trial will test whether taking butylphthalide capsules for 48 weeks improves thinking and memory in people aged 60–85 who have focal epilepsy and mild-to-moderate cognitive impairment while they continue their usual seizure medicines.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT07193277 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 60–85 with a diagnosis of focal epilepsy for at least 2 years, stable anti-seizure medication for ≥3 months with acceptable seizure control, and mild-to-moderate cognitive impairment (MoCA 18–25).
Not a fit: Patients with diagnosed dementia, clear stroke-related brain lesions or severe white matter disease, other neurological or systemic causes of cognitive impairment, or those outside the age or MoCA ranges are unlikely to benefit from this trial.
Why it matters
Potential benefit: If effective, butylphthalide could improve cognition and daily functioning in older people with focal epilepsy without requiring changes to their seizure medications.
How similar studies have performed: Butylphthalide has shown benefit in trials for vascular cognitive impairment and mild cognitive impairment, but its use specifically for epilepsy-associated cognitive problems has not been tested before.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wenzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.