Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation Stroke

November 10, 2026 updated by: Shandong Provincial Hospital

A Multicenter Randomized Controlled Trial Study of the Effect of Edaravone and Dexcamphan on the Repair of Blood-brain Barrier Injury in Acute Infarction of Anterior Circulation

This multicenter randomized controlled trial evaluates the effect of edaravone dexborneol on blood-brain barrier repair in patients with acute anterior circulation large artery atherosclerotic ischemic stroke within 48 hours of onset.

Patients are randomized 1:1 to receive either edaravone dexborneol (30mg/7.5mg BID IV) or edaravone (30mg BID IV) for 9±2 days, in addition to standard stroke treatment. The primary outcome is the change in blood-brain barrier permeability (Ktrans) measured by DCE-MRI. Secondary outcomes include neurological function scores, serum biomarkers, and safety events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
432

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Qinjian Sun Qinjian
  • Phone Number: +86 15168885366
  • Email: sqj1210@163.com

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Qinjian Sun Qinjian, Professor
          • Phone Number: +86 15168885366
          • Email: sqj1210@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Acute anterior circulation ischemic stroke within 48 hours of onset;
  2. Age 35-80 years;
  3. NIHSS score 4-24;
  4. Pre-stroke mRS score ≤1;
  5. Signed informed consent.

Exclusion Criteria:

  1. Lacunar infarction or multiple punctate infarcts;
  2. Intracranial hemorrhage;
  3. Moyamoya disease, vasculitis, or other immune-related infarcts;
  4. Combined tumor, intracranial infection, epilepsy, or severe systemic disease;
  5. History of non-lacunar ischemic stroke within 6 months;
  6. Severe liver or kidney dysfunction;
  7. MRI contraindications;
  8. Participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group

Participants receive edaravone 30mg BID intravenous drip for 9±2 days, plus standard stroke treatment.
Drug: Edaravone

Edaravone 30 mg administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.

Other Names:
  • Edaravone Injection
Experimental: Intervention Group

Participants receive edaravone dexborneol 30mg/7.5mg BID intravenous drip for 9±2 days, plus standard stroke treatment.
Drug: Edaravone Dexborneol

Edaravone dexborneol (30 mg/7.5 mg) administered by intravenous drip twice daily (BID) for 9±2 days, in addition to standard guideline-based treatment for acute ischemic stroke.

Other Names:
  • Edaravone and Dexborneol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Ktrans (blood-brain barrier permeability) measured by DCE-MRI
Time Frame: From baseline (24-48 hours after stroke onset) to day 9±2 after treatment

Change in the volume transfer constant (Ktrans) in the infarct region, quantifying the degree of blood-brain barrier repair from baseline (within 24-48 hours after onset) to day 9±2 after treatment, assessed by dynamic contrast-enhanced MRI (DCE-MRI).
From baseline (24-48 hours after stroke onset) to day 9±2 after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in serum Occludin level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Occludin level measured by Simoa technology. Unit: pg/mL.
Baseline to day 9±2 post-treatment
Change in serum Fibronectin level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Fibronectin level measured by Simoa technology. Unit: ng/mL.
Baseline to day 9±2 post-treatment
Change in serum MMP-9 level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Matrix Metalloproteinase-9 (MMP-9) level measured by Simoa technology. Unit: ng/mL.
Baseline to day 9±2 post-treatment
Change in serum UCHL1 level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Ubiquitin C-terminal Hydrolase L1 (UCHL1) level measured by Simoa technology. Unit: pg/mL.
Baseline to day 9±2 post-treatment
Change in serum NOS level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Nitric Oxide Synthase (NOS) level measured by Simoa technology. Unit: assay-specific unit.
Baseline to day 9±2 post-treatment
Change in serum NSE level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Neuron-Specific Enolase (NSE) level measured by Simoa technology. Unit: ng/mL.
Baseline to day 9±2 post-treatment
Change in serum GFAP level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Glial Fibrillary Acidic Protein (GFAP) level measured by Simoa technology. Unit: pg/mL.
Baseline to day 9±2 post-treatment
Change in serum EAA level
Time Frame: Baseline to day 9±2 post-treatment

Change in serum Excitatory Amino Acids (EAA) level measured by Simoa technology. Unit: µmol/L or assay-defined unit.
Baseline to day 9±2 post-treatment
NIHSS score at day 9±2
Time Frame: Day 9±2 after treatment

National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42).
Day 9±2 after treatment
mRS score at day 9±2
Time Frame: Day 9±2 after treatment

modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6).
Day 9±2 after treatment
MMSE score at day 9±2
Time Frame: Day 9±2 after treatment

Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30).
Day 9±2 after treatment
MoCA score at day 9±2
Time Frame: Day 9±2 after treatment

Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30).
Day 9±2 after treatment
NIHSS score at day 90±7
Time Frame: Day 90±7 after treatment

National Institutes of Health Stroke Scale (NIHSS) score. Higher scores indicate worse neurological deficit (Range: 0-42).
Day 90±7 after treatment
mRS score at day 90±7
Time Frame: Day 90±7 after treatment

modified Rankin Scale (mRS) score. Higher scores indicate worse functional outcome (Range: 0-6).
Day 90±7 after treatment
MMSE score at day 90±7
Time Frame: Day 90±7 after treatment

Mini-Mental State Examination (MMSE) score. Higher scores indicate better cognitive function (Range: 0-30).
Day 90±7 after treatment
MoCA score at day 90±7
Time Frame: Day 90±7 after treatment

Montreal Cognitive Assessment (MoCA) score. Higher scores indicate better cognitive function (Range: 0-30).
Day 90±7 after treatment
Hemorrhagic transformation
Time Frame: From randomization to 90 days

Incidence of new cerebrovascular events during the study period.
From randomization to 90 days
New cerebrovascular events during the study
Time Frame: From randomization to day 90±7

Incidence of new cerebrovascular events (including new ischemic stroke, transient ischemic attack, or other cerebrovascular events) in enrolled patients during the study period.
From randomization to day 90±7
Death during the study
Time Frame: From randomization to day 90±7

All-cause mortality in enrolled patients during the study period.
From randomization to day 90±7
Other adverse events during the study
Time Frame: From randomization to day 90±7

Incidence of other adverse events (AEs) in enrolled patients during the study period, excluding serious adverse events, hemorrhagic transformation, new cerebrovascular events, and death. Adverse events will be coded using MedDRA and summarized by system organ class and preferred term.
From randomization to day 90±7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Provincial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tengzhou Central People's Hospital
Zibo Central Hospital
Liaocheng People's Hospital
Shengli Oilfield Hospital
Dongying People's Hospital
Shandong Province Third hospital
Zaozhuang Municipal Hospital
Heze Municipal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWYX:NO.2021-1020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings