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Edaravone Dexborneol for Post-Stroke Epilepsy (EDEN-PSE)

20. května 2026 aktualizováno: First Affiliated Hospital of Wenzhou Medical University

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.

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Edaravone Dexborneol group
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.
Lék: 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.
Komparátor placeba: Control group
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.
Lék: Placebo
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of participants with composite seizure-related events
Časové okno: 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.
Up to 24 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of participants with late-onset clinical seizures
Časové okno: Up to 24 months
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.
Up to 24 months
Proportion of participants with new or worsening epileptiform EEG abnormalities
Časové okno: Up to 24 months
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.
Up to 24 months
Time to first late-onset clinical seizure
Časové okno: Up to 24 months
Time from stroke onset to the first occurrence of a late-onset clinical seizure, measured in days.
Up to 24 months
Proportion of participants with electrographic seizures without clinical manifestations
Časové okno: Up to 24 months
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.
Up to 24 months
Proportion of participants with resolution of epileptiform EEG activity
Časové okno: At 3, 6, 12, 18, and 24 months
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.
At 3, 6, 12, 18, and 24 months
Number of seizure episodes per participant
Časové okno: Up to 24 months
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.
Up to 24 months
Proportion of participants with severe seizure outcomes
Časové okno: Up to 24 months
Severe seizure outcomes include progression to status epilepticus or generalized tonic-clonic seizures. The distribution of seizure severity will be recorded.
Up to 24 months
Change in Montreal Cognitive Assessment (MoCA) score from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Change in Mini-Mental State Examination (MMSE) score from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Change in modified Rankin Scale (mRS) score from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Change in NIH Stroke Scale (NIHSS) score from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Change in Stroke-Specific Quality of Life (SSQOL) score from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Change in Barthel Index from baseline
Časové okno: Baseline, 3, 6, 12, 18, and 24 months
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.
Baseline, 3, 6, 12, 18, and 24 months
Number of participants with recurrent stroke events
Časové okno: Up to 24 months
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.
Up to 24 months
Number of participants with all-cause mortality
Časové okno: Up to 24 months
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.
Up to 24 months
Change in tumor necrosis factor-alpha (TNF-α) levels from baseline
Časové okno: Baseline, 1 week, 1 month, 3 months, and 24 months
Serum TNF-α levels will be measured to assess inflammatory response. Changes from baseline at each time point will be analyzed.
Baseline, 1 week, 1 month, 3 months, and 24 months
Change in interleukin-1 beta (IL-1β) levels from baseline
Časové okno: Baseline, 1 week, 1 month, 3 months, and 24 months
Serum IL-1β levels will be measured as a marker of inflammation. Changes from baseline will be analyzed.
Baseline, 1 week, 1 month, 3 months, and 24 months
Change in cyclooxygenase-2 (COX-2) levels from baseline
Časové okno: Baseline, 1 week, 1 month, 3 months, and 24 months
COX-2 expression levels will be measured as part of inflammatory pathway assessment. Changes from baseline will be analyzed.
Baseline, 1 week, 1 month, 3 months, and 24 months
Change in inducible nitric oxide synthase (iNOS) levels from baseline
Časové okno: Baseline, 1 week, 1 month, 3 months, and 24 months
iNOS levels will be measured to evaluate inflammatory and oxidative stress responses. Changes from baseline will be analyzed.
Baseline, 1 week, 1 month, 3 months, and 24 months
Number of participants with treatment-emergent adverse events
Časové okno: Up to 24 months
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.
Up to 24 months
Number of participants with serious adverse events
Časové okno: Up to 24 months
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.
Up to 24 months
Number of participants who discontinued treatment due to adverse events
Časové okno: Up to 24 months
Treatment discontinuation due to adverse events will be recorded as a measure of drug tolerability.
Up to 24 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

First Affiliated Hospital of Wenzhou Medical University

Spolupracovníci

Ningbo Medical Center Lihuili Hospital
The Central Hospital of Lishui City
Ningbo No.2 Hospital
The Third Affiliated Hospital of Wenzhou Medical University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. června 2030

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

14. září 2025

První předloženo, které splnilo kritéria kontroly kvality

20. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KY2025-328-02 (Jiný identifikátor: Ethics Committee in Clinical Research (ECCR) of the First Affiliated Hospital of Wenzhou Medical University)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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