NCT07193277RecruitingPhase 4
Butylphthalide for Cognitive Impairment in Elderly Patients 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
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Epilepsy
- NCT number
- NCT07193277
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From 1 Sept 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other drug clinical trials within 30 days
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.