Butylphthalide Tested for Thinking Problems in Older People With Focal Epilepsy
Tests a capsule against placebo for memory and thinking problems in older people with epilepsy.
Plain-language title generated from the registry record
Registry title: Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
Key facts
- Where
- Wenzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 85 years old?
Source: NCT07193277, who can take part
Where in China
- First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Wenzhou Medical University
- Trial code
- NCT07193277
- Record updated
- 25 September 2025
- Original description
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 focal epilepsy.Read full original descriptionShow less
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 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 focal epilepsy.
Study Population: 220 elderly patients (60-85 years) with focal epilepsy and mild to moderate cognitive impairment (Montreal Cognitive Assessment score 18-25).
Intervention: Participants will be randomly assigned 1:1 to receive either butylphthalide soft capsules (0.2g three times daily) or matching placebo for 48 weeks, while continuing their stable anti-seizure medication regimen.
Primary Outcome: Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 48 weeks.
Secondary Outcomes: Changes in neuropsychological tests (Trail Making Test, Digit Span, Rey Auditory Verbal Learning Test), seizure control measures, functional status (Activities of Daily Living, Quality of Life in Epilepsy), and exploratory neurobiological markers.
This study addresses an important unmet medical need, as current epilepsy treatments focus primarily on seizure control but lack effective interventions for epilepsy-associated cognitive impairment. Butylphthalide, a neuroprotective agent approved for acute ischemic stroke in China, has shown promise in other cognitive disorders and may benefit this patient population through its multiple neuroprotective mechanisms.
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: Participation in other drug clinical trials within 30 days; 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; Other conditions deemed inappropriate for participation by investigators.