Acute Ischemic StrokePhase 2NCT04984577
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
A Phase 2 study testing Compound Edaravone Injection-Low dose, Compound Edaravone Injection-High dose and Edaravone Injection in people with Acute Ischemic Stroke, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Compound Edaravone Injection-Low dose, Compound Edaravone Injection-High dose and Edaravone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2021to 31 Dec 2026
- Phase
- Phase 2
- 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
- Hospitalized patients, diagnosed of ischemic stroke;
- Onset of stroke is less than or equal to 48 hours;
- There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
- Patients signed written inform consent
Who cannot join
- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Iatrogenic stroke;
- Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
- The mRS score prior to this onset is greater than 1;
- Transient ischemic attack (TIA);
- SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
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- Patients with severe mental disorders and dementia;
- ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min;
- Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
- Thrombectomy or interventional therapy has been applied or planned after this onset;
- Patients with malignant tumors or receiving concurrent antitumor treatment;
- Patients with severe systemic disease, life expectancy is less than 90 days;
- Allergic to edaravone , taurine or related excipients;
- Pregnant or lactating women;
- Have major surgery within 4 weeks before enrollment and not recovered enough to start the study;
- Participated in other clinical studies within 30 days before randomization;
- The investigators consider the patients are not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study
The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Compound Edaravone Injection-Low dose, Compound Edaravone Injection-High dose, Edaravone Injection, Placebo injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Edaravone Injection-Low doseDrug
Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
Compound Edaravone Injection-High doseDrug
Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
Edaravone InjectionDrug
Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
Placebo injectionDrug
Placebo injection, one dose every 12 hours, continue for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Compound Edaravone Injection-Low dose | Experimental | Not described Receives: Drug: Compound Edaravone Injection-Low dose |
| Compound Edaravone Injection-High dose | Experimental | Not described Receives: Drug: Compound Edaravone Injection-High dose |
| Edaravone Injection | Active comparator | Not described Receives: Drug: Edaravone Injection |
| Placebo Injection | Placebo comparator | Not described Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with mRS ≤1 on day 90
Measured: day 90
Secondary outcomes (6)
Changes of NIHSS score from baseline on day 14
Measured: day 14
The proportion of patients with mRS ≤2 on day 90
Measured: day 90
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
Measured: day 14, 30, 90
The proportion of patients with ADL-BI ≥95 on day 14, 30, 90
Measured: day 14, 30, 90
EQ-5D score on day 90
Measured: day 90
Ordinal Distribution of mRS on day 90
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start15 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Strategic realignment of sponsors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984577
- Sponsor's protocol ID
- NJYK-CPEDRV-II
- Status last verified
- Feb 2024
- First submitted
- 29 Jul 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke -- a Multi-center, Randomized, Double-blind, Parallel, Multi-doses and Active-controlled Study
- ClinicalTrials.gov ID
- NCT04984577
- Acronym / sponsor ID
- NJYK-CPEDRV-II
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Strategic realignment of sponsors.
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2021 (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 the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Compound Edaravone Injection-Low dose | Experimental | Drug: Compound Edaravone Injection-Low dose |
| Compound Edaravone Injection-High dose | Experimental | Drug: Compound Edaravone Injection-High dose |
| Edaravone Injection | Active comparator | Drug: Edaravone Injection |
| Placebo Injection | Placebo comparator | Drug: Placebo injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients, diagnosed of ischemic stroke;
- Onset of stroke is less than or equal to 48 hours;
- There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
- Patients signed written inform consent
Key exclusion criteria (17 listed)
- Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
- Iatrogenic stroke;
- Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
- The mRS score prior to this onset is greater than 1;
- Transient ischemic attack (TIA);
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 |
|---|---|---|
| Compound Edaravone Injection-Low doseCompound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days | Drug | Compound Edaravone Injection-Low dose |
| Compound Edaravone Injection-High doseCompound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days | Drug | Compound Edaravone Injection-High dose |
| Edaravone InjectionEdaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days | Drug | Edaravone Injection |
| Placebo injectionPlacebo injection, one dose every 12 hours, continue for 14 days | Drug | Placebo Injection |
Primary outcome
The proportion of patients with mRS ≤1 on day 90
Time frame: day 90
6 secondary outcomes
Changes of NIHSS score from baseline on day 14
Time frame: day 14
The proportion of patients with mRS ≤2 on day 90
Time frame: day 90
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
Time frame: day 14, 30, 90
The proportion of patients with ADL-BI ≥95 on day 14, 30, 90
Time frame: day 14, 30, 90
EQ-5D score on day 90
Time frame: day 90
Ordinal Distribution of mRS on day 90
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compound Edaravone Injection-Low dose, Compound Edaravone Injection-High dose and Edaravone Injection in people with Acute Ischemic Stroke, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site 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 4 inclusion and 17 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: paused, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with mRS ≤1 on day 90 (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.