RECRUITINGPhase 4INTERVENTIONAL

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Butylphthalide

Butylphthalide soft capsules (0.1g per capsule) manufactured by CSPC NBP Pharmaceutical Co., Ltd. Participants take 2 capsules (0.2g total) orally three times daily, 15-30 minutes before meals, for 48 weeks. This represents off-label use for cognitive impairment comorbid with epilepsy, as the drug is currently approved in China only for acute ischemic stroke treatment.

DRUG

Placebo

Matching placebo capsules identical in appearance, weight, and odor to butylphthalide soft capsules, manufactured by the same company following GMP standards. Participants take 2 capsules orally three times daily, 15-30 minutes before meals, for 48 weeks. Placebo contains starch and appropriate excipients.

Locations (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China