Ischemic Stroke, AcutePhase 3EARLYSNCT05885919
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
A Phase 3 study testing Edaravone Dexborneol Concentrated Solution for injection in people with Ischemic Stroke, Acute and Treatment Outcome, run by Xiangya Hospital of Central South University at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute, Treatment Outcome
- What is being tested?
- Edaravone Dexborneol Concentrated Solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Brain Hospital of Hunan Province
Changsha, Hunan, 410008
Liu Kun, PhD
Hunan Provincial People's Hospital
Changsha, Hunan, 410008
XiangYa School of Medicine
Changsha, Hunan, 410008
Zhang Xiangbin
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute, Treatment Outcome
- Being tested
- Edaravone Dexborneol Concentrated Solution for injection, Edaravone Dexborneol placebo
- Keywords
- Acute ischemic stroke, Semi-dark band, Brain cell protection, Time window, Erafurone dextrol injection, Treatment Outcome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edaravone Dexborneol Concentrated Solution for injectionDrug
Also called Xian Bi Xin,CFDA Approval Number H20200007
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.
Edaravone Dexborneol placeboDrug
Also called Xian Bi Xin placebo
Edaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Edaravone Dexborneol group | Experimental | Patients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days. Receives: Drug: Edaravone Dexborneol Concentrated Solution for injection |
| Edaravone Dexborneol Placebo group | Placebo comparator | Patients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days Receives: Drug: Edaravone Dexborneol placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke
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
Measured: 90 days
Secondary outcomes (5)
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Measured: 90 days
Modified Rankin scale
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).
Measured: 90 days
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Measured: 90 days
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Measured: 90 days
All-cause mortality
All-cause mortality at 90 days after randomization
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects with AIS who met the criteria for inclusion were stratified 1:1 from onset to use of the investigational drug: early (\< 3 hours) and late (3-6 hours). Each layer was then randomly assigned to two groups in a 1:1 ratio: the right group and the placebo group. Test group: Edaravone dextronicol concentrated solution for injection, 15ml / time (37.5mg / time, of which edaravone 30mg, (+)-2-camphol 7.5mg), that is, 3 bottles / time, 2 times a day, for 12±2 days; Control group: Equal dose of placebo, 15 ml / time, that is, 3 sticks / time, 2 times a day for 12±2 days.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhang Le, PhD, Principal investigator, Department of Neurology，XiangYa School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885919
- Sponsor's protocol ID
- Shenjingneike
- Acronym
- EARLYS
- Status last verified
- Apr 2023
- First submitted
- 14 May 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
PubMed 33588596GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05885919
- Acronym / sponsor ID
- EARLYS / Shenjingneike
- Conditions
- Ischemic Stroke, Acute, Treatment Outcome
- Keywords
- Acute ischemic stroke, Semi-dark band, Brain cell protection, Time window, Erafurone dextrol injection, Treatment Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects with AIS who met the criteria for inclusion were stratified 1:1 from onset to use of the investigational drug: early (< 3 hours) and late (3-6 hours). Each layer was then randomly assigned to two groups in a 1:1 ratio: the right group and the placebo group. Test group: Edaravone dextronicol concentrated solution for injection, 15ml / time (37.5mg / time, of which edaravone 30mg, (+)-2-camphol 7.5mg), that is, 3 bottles / time, 2 times a day, for 12±2 days; Control group: Equal dose of placebo, 15 ml / time, that is, 3 sticks / time, 2 times a day for 12±2 days.
| Arm | Type | Receives |
|---|---|---|
| Edaravone Dexborneol group | Experimental | Drug: Edaravone Dexborneol Concentrated Solution for injectionPatients in this arm will be given Edaravone Dexborneol Concentrated Solution for injection twice a day for 10 to 14 days. |
| Edaravone Dexborneol Placebo group | Placebo comparator | Drug: Edaravone Dexborneol placeboPatients in this arm will be given a placebo of Edaravone Dexborneol for injection twice a day for 10 to 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edaravone Dexborneol Concentrated Solution for injectionAlso: Xian Bi Xin,CFDA Approval Number H20200007Edaravone 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. | Drug | Edaravone Dexborneol group |
| Edaravone Dexborneol placeboAlso: Xian Bi Xin placeboEdaravone and Dexborneol placebo, 15 ml in 3 ampoule bottles, twice a day for 10 to 14 days. | Drug | Edaravone Dexborneol Placebo group |
Primary outcome
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
5 secondary outcomes
Neurological recovery
Time frame: 90 days
Modified Rankin scale
Time frame: 90 days
Quality of life score (EQ-5D)
Time frame: 90 days
The incidence of serious adverse events
Time frame: 90 days
All-cause mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Results publication: PubMed 33588596Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
- Results publication: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Le, PhD principal investigator
Department of Neurology，XiangYa School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Edaravone Dexborneol Concentrated Solution for injection in people with Ischemic Stroke, Acute and Treatment Outcome, run by Xiangya Hospital of Central South University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Le, PhD (13973187150, zlzdzlzd@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 90-day mRS score of 0 to 2 in participants with acute ischaemic stroke (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.