Actively Recruiting
Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2025-09-25
220
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
T
Taizhou Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60-85 years (inclusive)
- Diagnosed with focal epilepsy according to ILAE 2025 standards, with disease duration of at least 2 years
- Receiving stable anti-seizure medication treatment for at least 3 months with good seizure control (monthly frequency 4 or fewer in past 3 months)
- Montreal Cognitive Assessment score between 18 and 25 points (inclusive)
- Basic Chinese language comprehension and expression ability to cooperate with neuropsychological testing
- Voluntary participation and signed informed consent
You will not qualify if you...
- Diagnosed with any type of dementia, including Alzheimer's disease or vascular dementia
- History of stroke with lesions on neuroimaging or severe white matter lesions on brain MRI
- Other neurological diseases causing cognitive impairment such as traumatic brain injury, encephalitis, or hydrocephalus
- Systemic diseases causing cognitive impairment including severe cardiac, liver, kidney dysfunction, or endocrine diseases
- Current severe depression or psychiatric disorders affecting cognitive assessment
- History of alcohol dependence, drug abuse, or substance use affecting cognitive function
- Allergy to butylphthalide or its excipients
- Participation in other drug clinical trials within the past 30 days
- Any other conditions considered inappropriate for participation by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
H
Huiqin Xu, MD
CONTACT
J
Jiahe Lin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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