Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset
NCT ID: NCT04486430
Last Updated: 2020-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
236 participants
INTERVENTIONAL
2017-03-02
2019-12-13
Brief Summary
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Detailed Description
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In the present phase II study, patients with acute ischemic stroke within 6 hours of onset would be assigned randomly to one of four groups as follows:
* Group A receiving 2.75g Neu2000KWL for 5 days
* Group B receiving 5.25g Neu2000KWL for 5 days
* Group C receiving 6.00g Neu2000KWL for 5 days
* Group D receiving placebo for 5 days
Patients will receive intravenous infusion of the clinical study drug twice a day at 12±1 hour intervals for 5 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Neu2000KWL 2750mg dose group
Low dose group
Neu2000KWL
1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
Neu2000KWL 5250mg dose group
Middle dose group
Neu2000KWL
1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Neu2000KWL 6000mg dose group
High dose group
Neu2000KWL
1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Placebo
Placebo
Placebos
1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours
Interventions
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Neu2000KWL
1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
Neu2000KWL
1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Neu2000KWL
1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
Placebos
1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;
3. patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;
4. patients within 6 hours of onset or the last time known to be symptom free (within 6 hours of the start of sleep for ischemic stroke patients with onset during sleep), and who receive a CT test before the clinical study;
5. Informed consent should be signed from the patient or patient's legally authorized representative;
6. patients with premorbid mRS score of 0\~1;
7. patients with no history of myocardial infarction within last 3 months;
8. patients with no heart, liver, kidney and lung function deficit;
9. patients with no hemorrhagic diseases within last 3 months;
10. patients with no haematological diseases.
Exclusion Criteria
2. Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);
3. Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;
4. Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;
5. Pregnant or lactating women. Note: the pregnancy test of fertile women must be negative before randomization into groups, and female patients must take appropriate contraceptive methods at least for 3 weeks prior to the clinical study and over the next 7 days following the last injection of test drugs;
6. Pre-existing medical, neurologic, or psychiatric diseases that would confound the neurologic, functional, or imaging evaluations, such as persistent deficit from previous ischemic stroke;
7. Malignant tumor or other critical disease;
8. Patients with a history of epilepsy or undergoing seizure on onset of the ischemic stroke
9. A history of intracranial hemorrhage;
10. Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in three consecutive times after admission;
11. A history of severe injury and surgical operation within the last 3 months;
12. Consciousness disorder as defined as "NIHSS Ia score ≥2 ";
13. Complete atrioventricular block bradycardia;
14. Cardiac function rating above II level according to the New York heart association (NYHA) grade of cardiac function, history of congestive heart failure (CHF);
15. With primary liver and kidney disease, AST or ALT 2 times greater than upper normal limit, serum creatinine \>2.0 mg/dL or \>176.8 µmol/L;
16. International normalized ratio (INR) \> 1.7 or current use of oral anticoagulants, except aspirin, clopidogrel, subcutaneous heparin or warfarin;
17. With bleeding tendency disease (such as hemophilia), partial thromboplastin time (PTT) \> 3 ×the upper limit of normal;
18. A history of, or known current problems with, drug or alcohol abuse;
19. A irritability experience of the study drugs or drugs with similar chemical structures;
20. Participation in other clinical trials or studies before this study within the last 3 months;
21. Researchers consider that patients don't suit for the study.
22. Hepatitis B and C, HIV-positive patients
1. patients with high density lesions associated with haemorrhage on CT scan after admission;
2. patients with significant lower density lesions of 1/3 middle cerebral artery on CT scan after admission;
3. patients with intracranial parenchymal tumors on CT scan after admission.
35 Years
75 Years
ALL
No
Sponsors
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Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.
UNKNOWN
Subei People's Hospital of Jiangsu Province
OTHER
The First Hospital of Jilin University
OTHER
First Hospital of China Medical University
OTHER
General Hospital of Shenyang Military Region
OTHER
The First Affiliated Hospital of BaoTou Medical College
OTHER
Xuanwu Hospital, Beijing
OTHER
Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
Tianjin First Central Hospital
OTHER
Tianjin Huanhu Hospital
OTHER
Hebei Medical University Third Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Hebei General Hospital
OTHER
Second Hospital of Shanxi Medical University
OTHER
Shandong Provincial Hospital
OTHER_GOV
Qilu Hospital of Shandong University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Nanjing PLA General Hospital
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Minhang Central Hospital
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
Guangzhou First People's Hospital
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
First Affiliated Hospital of Jinan University
OTHER
Tongji Hospital
OTHER
The Central Hospital of Lishui City
OTHER
Shanghai Pudong New Area People's Hospital
OTHER
Inner Mongolia Baogang Hospital
OTHER
Daqing Oil Field Hospital
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
Vice President of Tian Tan Hospital, Director of Neurology Center
Principal Investigators
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Meng Wang, MD, Ph.D
Role: STUDY_DIRECTOR
IRB of Beijing Tiantan Hospital, Capital Medical University
Locations
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Beijing Stroke Association
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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YWZC-PLJY0125
Identifier Type: -
Identifier Source: org_study_id
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