Post-stroke EpilepsyPhase 3EDEN-PSENCT07604350
Edaravone Dexborneol for Post-Stroke Epilepsy
A Phase 3 study testing Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months. in people with Post-stroke Epilepsy and Post-stroke Seizure, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Epilepsy, Post-stroke Seizure
- What is being tested?
- Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: 1. Adults aged 18 to 80 years, of either sex.
- Diagnosis of acute ischemic stroke confirmed by clinical presentation and neuroimaging (MRI or CT).
- Time from stroke onset to screening/randomization ≤48 hours.
- 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).
- 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.
- Conscious at enrollment or with recovered consciousness after treatment, and able to cooperate with sublingual medication administration and follow-up assessments.
- 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.
- History of ischemic or hemorrhagic stroke within 12 months prior to the index stroke.
- Large cerebral infarction with severe intracranial hypertension on imaging after stroke, with limited life expectancy or inability to complete follow-up.
- Severe renal impairment (significantly reduced eGFR according to contraindications of edaravone dexborneol) or a history of edaravone-related renal injury.
- 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.
- Known hypersensitivity to edaravone or borneol, or a history of severe drug allergy.
- Pregnant or breastfeeding women; women of childbearing potential unwilling to use effective contraception.
- Presence of other serious diseases (e.g., advanced malignancy) that may affect survival or study compliance.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Xinshi Wang, 8613757897051, wangxinshi@wmu.edu.cn
wangxinshi@wmu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study of Edaravone Dexborneol Sublingual Tablets for the Prevention of Post-Stroke Epilepsy
This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk.
Eligible participants are adults aged 18-80 years with a confirmed diagnosis of acute ischemic stroke by clinical and imaging criteria (MRI or CT), enrolled within 48 hours of stroke onset. High risk for post-stroke epilepsy is defined as a SeLECT-EEG score ≥7. Patients must have no prior history of epilepsy or other central nervous system disorders associated with seizures. Key exclusion criteria include prior seizures before enrollment, recent stroke within the past 12 months, severe renal or hepatic dysfunction, significant cardiac insufficiency, drug hypersensitivity, pregnancy or lactation, and other conditions deemed unsuitable by investigators.
Read more
A total of approximately 160 participants will be randomized in a 1:1 ratio to receive either Edaravone Dexborneol sublingual tablets or matching placebo.
The primary endpoint is a composite outcome assessed within 2 years, defined as the occurrence of either: (1) definite clinical epileptic seizures, or (2) new-onset or worsening epileptiform EEG abnormalities (including IEDs, PDs, LRDAs) or electrographic seizures.
Secondary endpoints include: incidence of individual components of the primary outcome; time to first seizure; characteristics, severity, and frequency of seizures; longitudinal changes and resolution rate of epileptiform EEG activity; cognitive function assessed by MoCA and MMSE; neurological outcomes evaluated by mRS and NIHSS; quality of life and functional independence measured by SSQOL and Barthel Index; recurrence of stroke and all-cause mortality; changes in inflammatory biomarkers (TNF-α, IL-1β, COX-2, iNOS); and safety outcomes including treatment-emergent adverse events, serious adverse events, laboratory abnormalities, and treatment discontinuation due to adverse events.
All efficacy and safety outcomes will be independently reviewed by a blinded adjudication committee. Statistical analyses will include chi-square or Fisher's exact tests for categorical outcomes, Kaplan-Meier survival analysis with log-rank tests for time-to-event data, and Cox proportional hazards models to adjust for potential confounders.
The study period is planned from June 2026 to June 2030.
- Conditions
- Post-stroke Epilepsy, Post-stroke Seizure
- Being tested
- Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months., Placebo
- Keywords
- post-stroke epilepsy, edaravone dexborneol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months.Drug
In the experimental group, patients received edaravone dexborneol sublingual tablets in addition to standard stroke therapy. Each tablet contained edaravone 30 mg plus borneol 6 mg, administered as one tablet sublingually twice daily (with an interval of ≥6 hours between doses). Treatment was initiated as early as possible within 48 hours after stroke onset and continued for consecutive three months.
PlaceboDrug
In the control group, patients received placebo sublingual tablets identical in appearance, formulation, and odor to the investigational product (edaravone 0 mg plus borneol 60 μg, with trace borneol added to ensure odor matching). Administration was initiated within 48 hours of stroke onset, at a regimen of one tablet sublingually twice daily (≥6-hour interval between doses), continued for consecutive three months.
| Study group | Role | What they receive |
|---|---|---|
| Edaravone Dexborneol group | Experimental | Participants in the experimental group will receive edaravone dexborneol sublingual tablets in addition to standard stroke therapy. Each tablet contains edaravone 30 mg and borneol 6 mg. The drug will be administered as one tablet sublingually twice daily, with an interval of at least 6 hours between doses. Treatment will be initiated within 48 hours after stroke onset and continued for 3 months. Receives: Drug: Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months. |
| Control group | Placebo comparator | Participants in the control group will receive matching placebo sublingual tablets with identical appearance, dosage form, and odor to the experimental drug. The administration method, dosing frequency, and treatment duration will be the same as in the experimental group. Both groups will receive standard stroke secondary prevention and rehabilitation therapy, without additional antiepileptic medications. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with composite seizure-related events
Composite seizure-related events are defined as the occurrence of any of the following during follow-up: (1) clinical epileptic seizures occurring more than 7 days after stroke onset; (2) newly developed or worsening epileptiform activity on electroencephalography (EEG), including interictal epileptiform discharges (IEDs), periodic discharges (PDs), or lateralized rhythmic delta activity (LRDA); or (3) electrographic seizures.
Measured: Up to 24 months
Secondary outcomes (22)
Number of participants with late-onset clinical seizures
Late-onset seizures are defined as clinical epileptic seizures occurring more than 7 days after stroke onset. The proportion of participants experiencing at least one seizure during follow-up will be recorded.
Measured: Up to 24 months
Proportion of participants with new or worsening epileptiform EEG abnormalities
Epileptiform EEG abnormalities include interictal epileptiform discharges (IEDs), periodic discharges (PDs), and lateralized rhythmic delta activity (LRDA). New abnormalities are defined as findings not present on baseline EEG. Worsening is defined as progression of pre-existing abnormalities compared with baseline, including increased frequency, transition to a continuous pattern, or expansion in spatial distribution.
Measured: Up to 24 months
Time to first late-onset clinical seizure
Time from stroke onset to the first occurrence of a late-onset clinical seizure, measured in days.
Measured: Up to 24 months
Proportion of participants with electrographic seizures without clinical manifestations
Electrographic seizures without clinical manifestations are defined as seizure activity detected on electroencephalography (EEG) without corresponding observable clinical symptoms. Participants will be counted as having an event if one or more such events are detected during follow-up.
Measured: Up to 24 months
Proportion of participants with resolution of epileptiform EEG activity
Among participants with epileptiform EEG activity at baseline, the proportion achieving resolution (conversion to normal EEG without epileptiform discharges) will be assessed at each follow-up visit.
Measured: At 3, 6, 12, 18, and 24 months
Number of seizure episodes per participant
Total number of seizure episodes per participant during the 24-month follow-up period will be recorded. Median seizure frequency will be compared between groups.
Measured: Up to 24 months
Proportion of participants with severe seizure outcomes
Severe seizure outcomes include progression to status epilepticus or generalized tonic-clonic seizures. The distribution of seizure severity will be recorded.
Measured: Up to 24 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA; total score range 0-30, higher scores indicate better cognitive function). Changes in score from baseline will be evaluated at each follow-up visit.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Change in Mini-Mental State Examination (MMSE) score from baseline
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE; total score range 0-30, higher scores indicate better cognitive function). Changes in score from baseline will be evaluated at each follow-up visit.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Change in modified Rankin Scale (mRS) score from baseline
Functional neurological outcome will be assessed using the modified Rankin Scale (mRS; total score range 0-6, higher scores indicate greater disability). Changes from baseline will be analyzed.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Change in NIH Stroke Scale (NIHSS) score from baseline
Neurological deficit severity will be assessed using the National Institutes of Health Stroke Scale (NIHSS; total score range 0-42, higher scores indicate greater neurological deficit). Changes from baseline will be analyzed.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Change in Stroke-Specific Quality of Life (SSQOL) score from baseline
Quality of life will be assessed using the Stroke-Specific Quality of Life (SSQOL) scale (total score range 49-245, higher scores indicate better quality of life). Changes in SSQOL total score from baseline will be evaluated at each follow-up time point.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Change in Barthel Index from baseline
Activities of daily living will be assessed using the Barthel Index (total score range 0-100, higher scores indicate greater independence). Changes in Barthel Index score from baseline will be evaluated at each follow-up time point.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Number of participants with recurrent stroke events
Recurrent stroke events include both ischemic and hemorrhagic stroke occurring after the index stroke. The number of participants experiencing at least one recurrent stroke will be recorded.
Measured: Up to 24 months
Number of participants with all-cause mortality
All-cause mortality will be defined as death from any cause occurring during the study period. The number of participants who die during follow-up will be recorded.
Measured: Up to 24 months
Change in tumor necrosis factor-alpha (TNF-α) levels from baseline
Serum TNF-α levels will be measured to assess inflammatory response. Changes from baseline at each time point will be analyzed.
Measured: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in interleukin-1 beta (IL-1β) levels from baseline
Serum IL-1β levels will be measured as a marker of inflammation. Changes from baseline will be analyzed.
Measured: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in cyclooxygenase-2 (COX-2) levels from baseline
COX-2 expression levels will be measured as part of inflammatory pathway assessment. Changes from baseline will be analyzed.
Measured: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in inducible nitric oxide synthase (iNOS) levels from baseline
iNOS levels will be measured to evaluate inflammatory and oxidative stress responses. Changes from baseline will be analyzed.
Measured: Baseline, 1 week, 1 month, 3 months, and 24 months
Number of participants with treatment-emergent adverse events
Treatment-emergent adverse events (TEAEs) are defined as adverse events occurring after initiation of study treatment. The number of participants experiencing at least one TEAE will be recorded.
Measured: Up to 24 months
Number of participants with serious adverse events
Serious adverse events (SAEs) include events that result in death, are life-threatening, require hospitalization, or result in significant disability. The number of participants experiencing at least one SAE will be recorded.
Measured: Up to 24 months
Number of participants who discontinued treatment due to adverse events
Treatment discontinuation due to adverse events will be recorded as a measure of drug tolerability.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-stroke EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, The Central Hospital of Lishui City, Ningbo No.2 Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604350
- Sponsor's protocol ID
- KY2025-328-02
- Other IDs
- KY2025-328-02
- Acronym
- EDEN-PSE
- Status last verified
- May 2026
- First submitted
- 14 Sep 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be publicly shared due to privacy and ethical considerations. However, data may be made available to qualified researchers upon reasonable request, subject to institutional review and data sharing agreements.
Publications
Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
PubMed 38372981Qiu W, Chen R, Pan L, Li Y, Xu Y, Li Y, Guo A, Huang W, Tan T, Li P, Xie C, Xu H, Lin L, Wang X. Edaravone dexborneol exerts anti-epileptic effects on rodent temporal lobe epilepsy by promoting NMDAR deactivation and inhibiting oxidative stress. Phytomedicine. 2025 May;140:156558. doi: 10.1016/j.phymed.2025.156558. Epub 2025 Mar 1.
PubMed 40054180Galovic M, Dohler N, Erdelyi-Canavese B, Felbecker A, Siebel P, Conrad J, Evers S, Winklehner M, von Oertzen TJ, Haring HP, Serafini A, Gregoraci G, Valente M, Janes F, Gigli GL, Keezer MR, Duncan JS, Sander JW, Koepp MJ, Tettenborn B. Prediction of late seizures after ischaemic stroke with a novel prognostic model (the SeLECT score): a multivariable prediction model development and validation study. Lancet Neurol. 2018 Feb;17(2):143-152. doi: 10.1016/S1474-4422(17)30404-0.
PubMed 29413315Hesdorffer DC, Benn EK, Cascino GD, Hauser WA. Is a first acute symptomatic seizure epilepsy? Mortality and risk for recurrent seizure. Epilepsia. 2009 May;50(5):1102-8. doi: 10.1111/j.1528-1167.2008.01945.x. Epub 2009 Jan 26.
PubMed 19374657
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study of Edaravone Dexborneol Sublingual Tablets for the Prevention of Post-Stroke Epilepsy
- ClinicalTrials.gov ID
- NCT07604350
- Acronym / sponsor ID
- EDEN-PSE / KY2025-328-02
- Conditions
- Post-stroke Epilepsy, Post-stroke Seizure
- Keywords
- post-stroke epilepsy, edaravone dexborneol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, The Central Hospital of Lishui City, Ningbo No.2 Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk.
Eligible participants are adults aged 18-80 years with a confirmed diagnosis of acute ischemic stroke by clinical and imaging criteria (MRI or CT), enrolled within 48 hours of stroke onset. High risk for post-stroke epilepsy is defined as a SeLECT-EEG score ≥7. Patients must have no prior history of epilepsy or other central nervous system disorders associated with seizures. Key exclusion criteria include prior seizures before enrollment, recent stroke within the past 12 months, severe renal or hepatic dysfunction, significant cardiac insufficiency, drug hypersensitivity, pregnancy or lactation, and other conditions deemed unsuitable by investigators.
A total of approximately 160 participants will be randomized in a 1:1 ratio to receive either Edaravone Dexborneol sublingual tablets or matching placebo.
The primary endpoint is a composite outcome assessed within 2 years, defined as the occurrence of either: (1) definite clinical epileptic seizures, or (2) new-onset or worsening epileptiform EEG abnormalities (including IEDs, PDs, LRDAs) or electrographic seizures.
Secondary endpoints include: incidence of individual components of the primary outcome; time to first seizure; characteristics, severity, and frequency of seizures; longitudinal changes and resolution rate of epileptiform EEG activity; cognitive function assessed by MoCA and MMSE; neurological outcomes evaluated by mRS and NIHSS; quality of life and functional independence measured by SSQOL and Barthel Index; recurrence of stroke and all-cause mortality; changes in inflammatory biomarkers (TNF-α, IL-1β, COX-2, iNOS); and safety outcomes including treatment-emergent adverse events, serious adverse events, laboratory abnormalities, and treatment discontinuation due to adverse events.
All efficacy and safety outcomes will be independently reviewed by a blinded adjudication committee. Statistical analyses will include chi-square or Fisher's exact tests for categorical outcomes, Kaplan-Meier survival analysis with log-rank tests for time-to-event data, and Cox proportional hazards models to adjust for potential confounders.
The study period is planned from June 2026 to June 2030.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edaravone Dexborneol group | Experimental | Drug: Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months.Participants in the experimental group will receive edaravone dexborneol sublingual tablets in addition to standard stroke therapy. Each tablet contains edaravone 30 mg and borneol 6 mg. The drug will be administered as one tablet sublingually twice daily, with an interval of at least 6 hours between doses. Treatment will be initiated within 48 hours after stroke onset and continued for 3 months. |
| Control group | Placebo comparator | Drug: PlaceboParticipants in the control group will receive matching placebo sublingual tablets with identical appearance, dosage form, and odor to the experimental drug. The administration method, dosing frequency, and treatment duration will be the same as in the experimental group. Both groups will receive standard stroke secondary prevention and rehabilitation therapy, without additional antiepileptic medications. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months.In the experimental group, patients received edaravone dexborneol sublingual tablets in addition to standard stroke therapy. Each tablet contained edaravone 30 mg plus borneol 6 mg, administered as one tablet sublingually twice daily (with an interval of ≥6 hours between doses). Treatment was initiated as early as possible within 48 hours after stroke onset and continued for consecutive three months. | Drug | Edaravone Dexborneol group |
| PlaceboIn the control group, patients received placebo sublingual tablets identical in appearance, formulation, and odor to the investigational product (edaravone 0 mg plus borneol 60 μg, with trace borneol added to ensure odor matching). Administration was initiated within 48 hours of stroke onset, at a regimen of one tablet sublingually twice daily (≥6-hour interval between doses), continued for consecutive three months. | Drug | Control group |
Primary outcome
Proportion of participants with composite seizure-related events
Time frame: Up to 24 months
Composite seizure-related events are defined as the occurrence of any of the following during follow-up: (1) clinical epileptic seizures occurring more than 7 days after stroke onset; (2) newly developed or worsening epileptiform activity on electroencephalography (EEG), including interictal epileptiform discharges (IEDs), periodic discharges (PDs), or lateralized rhythmic delta activity (LRDA); or (3) electrographic seizures.
22 secondary outcomes
Number of participants with late-onset clinical seizures
Time frame: Up to 24 months
Proportion of participants with new or worsening epileptiform EEG abnormalities
Time frame: Up to 24 months
Time to first late-onset clinical seizure
Time frame: Up to 24 months
Proportion of participants with electrographic seizures without clinical manifestations
Time frame: Up to 24 months
Proportion of participants with resolution of epileptiform EEG activity
Time frame: At 3, 6, 12, 18, and 24 months
Number of seizure episodes per participant
Time frame: Up to 24 months
Proportion of participants with severe seizure outcomes
Time frame: Up to 24 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Change in Mini-Mental State Examination (MMSE) score from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Change in modified Rankin Scale (mRS) score from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Change in NIH Stroke Scale (NIHSS) score from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Change in Stroke-Specific Quality of Life (SSQOL) score from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Change in Barthel Index from baseline
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Number of participants with recurrent stroke events
Time frame: Up to 24 months
Number of participants with all-cause mortality
Time frame: Up to 24 months
Change in tumor necrosis factor-alpha (TNF-α) levels from baseline
Time frame: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in interleukin-1 beta (IL-1β) levels from baseline
Time frame: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in cyclooxygenase-2 (COX-2) levels from baseline
Time frame: Baseline, 1 week, 1 month, 3 months, and 24 months
Change in inducible nitric oxide synthase (iNOS) levels from baseline
Time frame: Baseline, 1 week, 1 month, 3 months, and 24 months
Number of participants with treatment-emergent adverse events
Time frame: Up to 24 months
Number of participants with serious adverse events
Time frame: Up to 24 months
Number of participants who discontinued treatment due to adverse events
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 38372981Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.
- Background: PubMed 40054180Qiu W, Chen R, Pan L, Li Y, Xu Y, Li Y, Guo A, Huang W, Tan T, Li P, Xie C, Xu H, Lin L, Wang X. Edaravone dexborneol exerts anti-epileptic effects on rodent temporal lobe epilepsy by promoting NMDAR deactivation and inhibiting oxidative stress. Phytomedicine. 2025 May;140:156558. doi: 10.1016/j.phymed.2025.156558. Epub 2025 Mar 1.
- Background: PubMed 29413315Galovic M, Dohler N, Erdelyi-Canavese B, Felbecker A, Siebel P, Conrad J, Evers S, Winklehner M, von Oertzen TJ, Haring HP, Serafini A, Gregoraci G, Valente M, Janes F, Gigli GL, Keezer MR, Duncan JS, Sander JW, Koepp MJ, Tettenborn B. Prediction of late seizures after ischaemic stroke with a novel prognostic model (the SeLECT score): a multivariable prediction model development and validation study. Lancet Neurol. 2018 Feb;17(2):143-152. doi: 10.1016/S1474-4422(17)30404-0.
- Background: PubMed 19374657Hesdorffer DC, Benn EK, Cascino GD, Hauser WA. Is a first acute symptomatic seizure epilepsy? Mortality and risk for recurrent seizure. Epilepsia. 2009 May;50(5):1102-8. doi: 10.1111/j.1528-1167.2008.01945.x. Epub 2009 Jan 26.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be publicly shared due to privacy and ethical considerations. However, data may be made available to qualified researchers upon reasonable request, subject to institutional review and data sharing agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment of edaravone dexborneol sublingual tablets containin edaravone 30 mg plus borneol 6 mg, twice daily (with an interval of ≥6 hours between doses) for three months. in people with Post-stroke Epilepsy and Post-stroke Seizure, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinshi Wang (+8613757897051, wangxinshi@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with composite seizure-related events (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07604350, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.