Edaravone Dexborneol for Post-Stroke Epilepsy

NCT07604350 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2025-328-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-stroke Epilepsy; Post-stroke Seizure

Keywords

post-stroke epilepsy; edaravone dexborneol

Outcome Measures

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.

  Up to 24 months

Secondary Outcomes (22)

• Number of participants with late-onset clinical seizures

  Up to 24 months

• Proportion of participants with new or worsening epileptiform EEG abnormalities

  Up to 24 months

• Time to first late-onset clinical seizure

  Up to 24 months

• Proportion of participants with electrographic seizures without clinical manifestations

  Up to 24 months

• Proportion of participants with resolution of epileptiform EEG activity

  At 3, 6, 12, 18, and 24 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Edaravone Dexborneol group

Placebo DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• 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

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (4)

• 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.

  PMID: 38372981 BACKGROUND

• Qiu 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.

  PMID: 40054180 BACKGROUND

• Galovic 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.

  PMID: 29413315 BACKGROUND

• Hesdorffer 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.

  PMID: 19374657 BACKGROUND

MeSH Terms

Interventions

isoborneol; WW Domain-Containing Oxidoreductase

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xinshi Wang

CONTACT

+8613757897051; wangxinshi@wmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)