BridgeMD
New treatment option for Focal Epilepsy
Official title Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
ClinicalTrials.gov ID: NCT07193277
What this study is testing
What is Butylphthalide?
Butylphthalide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal epilepsy.
Also referred to as DL-3-n-butylphthalide, NBP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- 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...
- Cognitive impairment: Montreal Cognitive Assessment (MoCA) score 18-25 points (inclusive)
- Basic Chinese language comprehension and expression ability, able to cooperate with neuropsychological testing
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.