Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke (EARLYS)

June 25, 2023 updated by: Xiangya Hospital of Central South University

Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke-A Multicenter, Randomized, Double-blind, Placebo-controlled, Trial

The primary objective of this study was to evaluate the efficacy and safety of initiation of edaravone dextivel therapy compared with placebo in patients with acute ischaemic stroke (early and late) and to explore the optimal time window for "brain cell protective therapy" of edaravone dexborneol.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy and safety of (early and late) initiation treatment of Edaravone Dexborneol versus placebo in patients with acute ischemic stroke, and to explore the optimal time window for "brain cell protective therapy" of Edaravone Dexborneol. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be stratified by time to trial drug: early (<3 hours) and late (3-6 hours). Then each layer will be randomly assigned into two groups by a 1:1 ratio after the ICF was received. Patients in one arm will be given 15ml edaravone and dexborneol concentrated solution for injection (37.5mg, containing edaravone 30mg and dexborneol 7.5mg) twice a day for 10-14 days, and those in the other arm will be given an equivalent placebo drug. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2 and the safety outcome is the proportion of severe adverse events.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Phase 3

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 Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Brain Hospital of Hunan Province
        • Contact:
          • Liu Kun, PhD
      • Changsha, Hunan, China, 410008
        • Hunan Provincial People's Hospital
      • Changsha, Hunan, China, 410008
        • XiangYa School of Medicine
        • Contact:
          • Zhang Xiangbin

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80 years old, gender is not limited;
  • Clinically confirmed acute ischemic stroke;
  • Within 6 hours of the onset of this stroke;
  • NIHSS score of 4-24 at enrollment;
  • mRS score before onset≤ 1 point;
  • Subject and subject's agent are able and willing to sign informed consent.

Exclusion Criteria:

  • CT indicates intracranial hemorrhagic diseases, such as hemorrhagic stroke, subdural hematoma, ventricular hemorrhage, or subarachnoid hemorrhage, etc.;
  • Previously known severe liver or kidney insufficiency (ALT or AST is greater than 3.0×ULN; serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or dialysis;
  • Systolic blood pressure≥220 mmHg or <90mmHg；
  • Recent stroke within prior 1 month；
  • Hypersensitive to edaravone, (+)-2- dexborneol or auxiliary materials;
  • Prior receipt of edaravone or any other neuroprotective drugs;
  • History of congenital or acquired hemorrhagic disease, coagulation factor deficiency disease, or thrombocytopenic disease, etc.;
  • Pregnancy, lactation, or planned pregnancy within 90 days;
  • Those who cannot complete informed consent or follow-up treatment due to severe mental disorder or dementia;
  • Those with a malignant tumor, severe systemic diseases, or predict survival time <90 days;
  • Participate in another interventional clinical study within 30 days before randomization or participate in another interventional clinical study;
  • The investigators consider the patients are not suitable for this trial.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edaravone Dexborneol group
Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days.
Drug: Edaravone Dexborneol Concentrated Solution for injection
Edaravone and Dexborneol Concentrated Solution for Injection, 15 ml (37.5 mg, containing edaravone 30 mg and dexborneol 7.5 mg) in 3 ampoule bottles, twice a day for 10 to 14 days.
Other Names:
  • Xian Bi Xin,CFDA Approval Number H20200007
Placebo Comparator: Edaravone Dexborneol Placebo group
Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days
Drug: Edaravone Dexborneol placebo
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
Other Names:
  • Xian Bi Xin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
Time Frame: 90 days
To assess the proportion of participants (early and late) who started edaravone dextrol compared with placebo with a 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological recovery
Time Frame: 90 days
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
90 days
Quality of life score (EQ-5D)
Time Frame: 90 days
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
90 days
The incidence of serious adverse events
Time Frame: 90 days
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
90 days
Modified Rankin scale
Time Frame: 90 days
used to evaluate the functional outcomes after AIS，good prognosis (mRS score 0-2), generally good prognosis (mRS score 3-4) , Poor prognosis (mRS >4 points).
90 days
All-cause mortality
Time Frame: 90 days
All-cause mortality at 90 days after randomization
90 days

Collaborators and Investigators

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

Sponsor

Xiangya Hospital of Central South University

Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Zhang Le, PhD, Department of Neurology，XiangYa School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shenjingneike

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.

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