Edaravone Dexborneol for Post-Stroke Epilepsy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 80 years, of either sex.
Disqualifiers
History of epilepsy or occurrence of any seizure prior to screening.
Trial design
Design model
Parallel
Treatments tested in this trial
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.
DrugIn 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.
Placebo
DrugIn 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Edaravone Dexborneol groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 24 monthsSecondary outcomes
1
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.
Time frame
Up to 24 months2
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.
Time frame
Up to 24 months3
Time to first late-onset clinical seizure
Time from stroke onset to the first occurrence of a late-onset clinical seizure, measured in days.
Time frame
Up to 24 months4
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.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wenzhou Medical University
Lead sponsor
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
The Central Hospital of Lishui City
Collaborator
Ningbo No.2 Hospital
Collaborator
Source ClinicalTrials.gov
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