Actively Recruiting
Safety and Efficacy of Butylphthalide Soft Capsules for Cognitive Impairment in Elderly Patients with Focal Epilepsy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2025-09-25
220
Participants Needed
1
Research Sites
35 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
Researchers are evaluating the safety and effectiveness of butylphthalide soft capsules for treating cognitive impairment in elderly patients with focal epilepsy. This trial focuses on patients aged 60 to 85 years who have mild to moderate cognitive impairment and have been diagnosed with focal epilepsy. The study addresses a significant need because current epilepsy treatments mainly control seizures but do not improve cognitive problems associated with epilepsy. Butylphthalide, a neuroprotective drug approved for stroke in China, may offer benefits for cognitive function through multiple protective mechanisms. Participants will be randomly assigned to receive either butylphthalide soft capsules (0.2g taken orally three times daily before meals) or matching placebo capsules for 48 weeks. All participants will continue their stable anti-seizure medication during the study. The trial is double-blinded and placebo-controlled, and it will be conducted across multiple centers. Both study groups will follow the same dosing schedule while researchers monitor responses. During the study, participants will undergo regular cognitive tests including the Montreal Cognitive Assessment (MoCA), Trail Making Tests, Digit Span tests, and Rey Auditory Verbal Learning Test. Researchers will also assess seizure frequency, daily functioning, and quality of life. Safety is monitored with laboratory tests and adverse event reporting throughout the 48-week treatment period. The main outcome is the change in MoCA score from baseline to 48 weeks, with secondary outcomes assessing various cognitive and functional measures and potential biomarkers.
CONDITIONS
Brief 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 classification, with disease duration of at least 2 years
- Receiving stable anti-seizure medication for at least 3 months with good seizure control (monthly seizures 4 or fewer in past 3 months)
- Mild to moderate cognitive impairment with Montreal Cognitive Assessment (MoCA) score between 18 and 25
- Basic ability to understand and communicate in Chinese
- Voluntary participation with 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 visible on brain imaging or severe white matter changes
- Other neurological diseases causing cognitive impairment, such as brain injury or encephalitis
- Severe systemic diseases affecting cognition, including heart, liver, kidney, or endocrine disorders
- Current severe depression or psychiatric disorders that affect cognitive testing
- History of alcohol dependence, drug abuse, or substance use impacting cognition
- Allergy to butylphthalide or its ingredients
- Participation in other drug trials within the last 30 days
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 48 weeks
Participants take butylphthalide soft capsules or matching placebo capsules orally three times daily before meals for 48 weeks while continuing their stable anti-seizure medication regimen. Comprehensive cognitive assessments and safety monitoring are conducted throughout this period.
Visits at baseline, 12, 24, 36, and 48 weeks
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
J
Jiahe Lin, PhD
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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