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Could a stroke pill boost brainpower in elderly epilepsy patients?

NCT ID NCT07193277

Symptom relief Sponsor: First Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether butylphthalide, a drug already used for stroke in China, can improve cognitive function in 220 elderly patients (ages 60-85) who have both focal epilepsy and mild cognitive impairment. Participants take the drug or a placebo for 48 weeks while continuing their usual seizure medication. The main goal is to see if thinking and memory scores improve, addressing a common problem that current epilepsy treatments don't help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
butylphthalide (a neuroprotective drug currently approved in China for acute ischemic stroke)
What this could lead to
If it works, this could point toward a treatment for cognitive decline in elderly people with epilepsy, filling a gap where current epilepsy drugs only control seizures.
What could go wrong
This is a Phase 4 trial with 220 participants, so results are still uncertain. Butylphthalide is not yet approved for this use, and the cognitive benefits seen in other conditions may not apply here. Side effects are possible, though the drug is generally well-tolerated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction focal epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Focal epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

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