Y-3 for Injection in the Treatment of Acute Ischemic Stroke
NCT ID: NCT06517173
Last Updated: 2024-09-19
Study Results
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Basic Information
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RECRUITING
PHASE3
998 participants
INTERVENTIONAL
2024-07-24
2025-07-31
Brief Summary
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Detailed Description
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Treatment was continued for 10 days (10 times), and follow-up was conducted until the 90th day from the first dose.
The trial is divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.
Screening/baseline period: After the subjects sign the informed consent form, they enter the screening/baseline period for screening examination.
Treatment period: Qualified subjects are randomly divided into groups in a 1:1 ratio and receive continuous treatment for 10 days (10 times) with Y-3 for injection and placebo respectively. During the treatment period, relevant examinations and evaluations required by the protocol will be carried out; PK blood samples from subjects were collected for population pharmacokinetic analysis.
Follow-up period: Subjects who have completed treatment will enter the follow-up period until the 90th day of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Y-3 for injection test group
The special solvent Y-3 for injection was extracted with a sterile syringe and injected into a Y-3 lyophilized powder vial for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h
Y-3 for injection
Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
Placebo control group
The special solvent Y-3 for injection was extracted with a sterile syringe and injected into the lyophilized powder vial of Y-3 simulant for injection. The vial was artificially vibrated until the powder was completely dissolved, and then injected into 250mL 0.9% sodium chloride injection with a sterile syringe for dilution, gently shaken and mixed, and intravenous infusion was performed for 60min±10min. The treatment was performed 10 times for 10 days. The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h. The time interval of each subsequent administration is 24h±1h
Placebo control group
Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
Interventions
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Y-3 for injection
Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
Placebo control group
Qualified subjects were randomly divided into groups in a 1:1 ratio and received continuous treatment with Y-3 injection (40 mg/dose, qd) or placebo control drug. The treatment was performed 10 times for 10 days.
Eligibility Criteria
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Inclusion Criteria
2. After onset of disease, ischemic stroke meeting the following characteristics: 7≤ NIHSS(National Institutes of Stroke score)≤20 , and the sum of the scores of the item 5 upper limb and item 6 lower limb ≥ 2 points. If patients received thrombolytic therapy, they would be screened and assessed by NIHSS score after thrombolysis;
3. Within 48 hours (inclusive) of onset;
4. Patients who were diagnosed as ischemic stroke according to Key Points in Diagnosis of Various Major Cerebrovascular Diseases 2019 in China and recovered well after the first or last onset of disease (mRS score ≤ 1 point before this episode);
5. The patient or his/her legal representative voluntarily signed informed consent form approved by the Ethics Committee.
Exclusion Criteria
2. Severe disturbance of consciousness: NIHSS score \> 1 on item 1a level of consciousness;
3. Transient ischemic attack (TIA);
4. Systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg after blood pressure control;
5. Previous diagnosis of severe mental disorders and severe dementia;
6. Previously diagnosed with depression or anxiety;
7. Receiving antidepressant or anxiolytic therapy;
8. Have been diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or alanine aminotransferase or aspartate aminotransferase \> 2.0 × upper limit of normal;
9. Have been diagnosed with severe active renal disease, renal dysfunction; or serum creatinine \> 1.5 × upper limit of normal;
10. After this episode, drugs with brain cell protective effect clarified in the package insert have been applied, such as commercially available edaravone,concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, citicoline, piracetam, oxiracetam, butylphenyl peptide, human urinary kininogenase (urinary kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (brain protein hydrolysate), deproteinized calf serum injection, deproteinized calf blood extract injection, etc.;
11. Thrombectomy or interventional therapy has been applied or planned after this episode;
12. Previous diagnosis of concurrent malignancy and ongoing anti-tumor therapy;
13. Previous diagnosis of severe systemic disease with expected survival times \< 90 days;
14. The patient is pregnant, lactating and the patient/patient's partner may become pregnant and plans to become pregnant during the trial;
15. Previously known hypersensitivity to the product or any of its excipients (15-hydroxystearate polyethylene glycol, propylene glycol, mannitol, potassium dihydrogen phosphate, dipotassium hydrogen phosphate trihydrate);
16. History of major surgery within 4 weeks prior to enrollment that impacts neurological score assessed by the investigator or impacts 90-day survival;
17. Participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study;
18. Investigator considered inappropriate for participation in this clinical study.
18 Years
81 Years
ALL
No
Sponsors
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Neurodawn Pharmaceutical Co., Ltd.
INDUSTRY
Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
Chief Physician
Locations
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Beijing Tiantan Hospital Capital Medical University Beijing
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Yongjun Wang
Role: backup
References
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Other Identifiers
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Y-3-LC-04
Identifier Type: -
Identifier Source: org_study_id
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