Could a simple tablet stop epilepsy after a stroke?
NCT ID NCT07604350
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a tablet called edaravone dexborneol can prevent epilepsy in people who have had a stroke and are at high risk. About 160 adults will receive either the tablet or a placebo for three months, starting within 48 hours of their stroke. Researchers will track seizures and brain activity over two years to see if the treatment helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Edaravone dexborneol sublingual tablets (edaravone 30 mg plus borneol 6 mg)
- What this could lead to
- If successful, this could provide a new way to prevent epilepsy in people who have had a stroke, reducing seizures and improving recovery.
- What could go wrong
- This is an early-stage trial with only 160 participants, so results may not apply to everyone. The treatment also has potential side effects, and it's not yet proven to work.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Adults aged 18 to 80 years, of either sex. 2\. Diagnosis of acute ischemic stroke confirmed by clinical presentation and neuroimaging (MRI or CT). 3\. Time from stroke onset to screening/randomization ≤48 hours. 4\. High risk of post-stroke epilepsy, defined as a SeLECT-EEG score ≥7, including: stroke severity (Se, 0-2 points), large-artery atherosclerosis etiology (L, 0-1 point), cortical involvement (C, 0-2 points), middle cerebral artery territory infarction (T, 0-1 point), and EEG findings (EEG, 0-2 points). 5\. No prior history of epilepsy before the index stroke, and no history of other central nervous system disorders (e.g., traumatic brain injury, brain tumor) associated with seizures. 6\. Conscious at enrollment or with recovered consciousness after treatment, and able to cooperate with sublingual medication administration and follow-up assessments. 7\. Provision of written informed consent by the patient or a legally authorized representative. Exclusion criteria: 1. History of epilepsy or occurrence of any seizure prior to screening. 2\. History of ischemic or hemorrhagic stroke within 12 months prior to the index stroke. 3\. Large cerebral infarction with severe intracranial hypertension on imaging after stroke, with limited life expectancy or inability to complete follow-up. 4\. Severe renal impairment (significantly reduced eGFR according to contraindications of edaravone dexborneol) or a history of edaravone-related renal injury. 5\. Severe hepatic dysfunction (ALT or AST \>3 times the upper limit of normal) or severe heart failure (New York Heart Association class III-IV) that may preclude tolerance to the study drug. 6\. Known hypersensitivity to edaravone or borneol, or a history of severe drug allergy. 7\. Pregnant or breastfeeding women; women of childbearing potential unwilling to use effective contraception. 8\. Presence of other serious diseases (e.g., advanced malignancy) that may affect survival or study compliance. 9\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
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Other studies related to the condition(s) this trial covers.
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