NCT07193277 Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
| NCT ID | NCT07193277 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Focal Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 220 participants in total. It began in 2025-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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
Contact & Investigator
Huiqin Xu, MD
PRINCIPAL INVESTIGATOR
Department of Neurology, First Affiliated Hospital of Wenzhou Medical University
Frequently Asked Questions
Who can join the NCT07193277 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Focal Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07193277 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07193277 currently recruiting?
Yes, NCT07193277 is actively recruiting participants. Contact the research team at xuhuiqin@wmu.edu.cn for enrollment information.
Where is the NCT07193277 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT07193277 clinical trial?
NCT07193277 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The principal investigator is Huiqin Xu, MD at Department of Neurology, First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 220 participants.
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