StrokePhase 2SalfaprodilNCT04486430
Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset
A Phase 2 study testing Neu2000KWL in people with Stroke and Cerebral Infarction, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Cerebral Infarction
- What is being tested?
- Neu2000KWL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2017to 13 Dec 2019
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 35 and 75 years;
- acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;
- patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;
- 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;
- Informed consent should be signed from the patient or patient's legally authorized representative;
- patients with premorbid mRS score of 0~1;
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- patients with no history of myocardial infarction within last 3 months;
- patients with no heart, liver, kidney and lung function deficit;
- patients with no hemorrhagic diseases within last 3 months;
- patients with no haematological diseases.
Who cannot join
- Any contraindication to CT and MRI (e.g., metal implants such as pacemakers, claustrophobia);
- Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);
- Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;
- Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;
- 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;
- Pre-existing medical, neurologic, or psychiatric diseases that would confound the neurologic, functional, or imaging evaluations, such as persistent deficit from previous ischemic stroke;
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- Malignant tumor or other critical disease;
- Patients with a history of epilepsy or undergoing seizure on onset of the ischemic stroke
- A history of intracranial hemorrhage;
- Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in three consecutive times after admission;
- A history of severe injury and surgical operation within the last 3 months;
- Consciousness disorder as defined as "NIHSS Ia score ≥2 ";
- Complete atrioventricular block bradycardia;
- Cardiac function rating above II level according to the New York heart association (NYHA) grade of cardiac function, history of congestive heart failure (CHF);
- 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;
- International normalized ratio (INR) > 1.7 or current use of oral anticoagulants, except aspirin, clopidogrel, subcutaneous heparin or warfarin;
- With bleeding tendency disease (such as hemophilia), partial thromboplastin time (PTT) > 3 ×the upper limit of normal;
- A history of, or known current problems with, drug or alcohol abuse;
- A irritability experience of the study drugs or drugs with similar chemical structures;
- Participation in other clinical trials or studies before this study within the last 3 months;
- Researchers consider that patients don't suit for the study.
- Hepatitis B and C, HIV-positive patients
- Imaging exclusion criteria:
- patients with high density lesions associated with haemorrhage on CT scan after admission;
- patients with significant lower density lesions of 1/3 middle cerebral artery on CT scan after admission;
- patients with intracranial parenchymal tumors on CT scan after admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of the Salfaprodil for Injection in Patients With Acute Ischemic Stroke
The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.
Read the detailed description
The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have been well documented in four animal models of stroke. Notable Safety of Neu2000 has been demonstrated in 168 human subjects conducted in the US and China as well as animals.
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
- Stroke, Cerebral Infarction
- Being tested
- Neu2000KWL, Placebos
- Keywords
- Stroke, the Salfaprodil for injection, Neu2000KWL, Neuroprotection, glutamate, free radical
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neu2000KWLDrug
Also called Salfaprodil for injection
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
Neu2000KWLDrug
Also called Salfaprodil for injection
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
Neu2000KWLDrug
Also called Salfaprodil for injection
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
PlacebosDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Neu2000KWL 2750mg dose group | Experimental | Low dose group Receives: Drug: Neu2000KWL |
| Neu2000KWL 5250mg dose group | Experimental | Middle dose group Receives: Drug: Neu2000KWL |
| Neu2000KWL 6000mg dose group | Experimental | High dose group Receives: Drug: Neu2000KWL |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.
The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.
Measured: days:14±2
Secondary outcomes (3)
Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection. 1. Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Measured: days 14±2, 30±2 and 90±7
Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Measured: days 14±2, 30±2 and 90±7
Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Measured: days 14±2, 30±2 and 90±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start2 Mar 2017
- Primary completion12 Jun 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd., Subei People's Hospital of Jiangsu Province, The First Hospital of Jilin University, First Hospital of China Medical University, General Hospital of Shenyang Military Region, The First Affiliated Hospital of BaoTou Medical College, Xuanwu Hospital, Beijing, Peking University First Hospital, Peking University Third Hospital, Tianjin First Central Hospital, Tianjin Huanhu Hospital, Hebei Medical University Third Hospital, The Second Hospital of Hebei Medical University, Hebei General Hospital, Second Hospital of Shanxi Medical University, Shandong Provincial Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Soochow University, Nanjing PLA General Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Minhang Central Hospital, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Guangzhou First People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University, Tongji Hospital, The Central Hospital of Lishui City, Shanghai Pudong New Area People's Hospital, Inner Mongolia Baogang Hospital, Daqing Oil Field Hospital
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Meng Wang, MD, Ph.D, Study director, IRB of Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486430
- Sponsor's protocol ID
- YWZC-PLJY0125
- Acronym
- Salfaprodil
- Status last verified
- Jan 2017
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- 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 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of the Salfaprodil for Injection in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04486430
- Acronym / sponsor ID
- Salfaprodil / YWZC-PLJY0125
- Conditions
- Stroke, Cerebral Infarction
- Keywords
- Stroke, the Salfaprodil for injection, Neu2000KWL, Neuroprotection, glutamate, free radical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd., Subei People's Hospital of Jiangsu Province, The First Hospital of Jilin University, First Hospital of China Medical University, General Hospital of Shenyang Military Region, The First Affiliated Hospital of BaoTou Medical College, Xuanwu Hospital, Beijing, Peking University First Hospital, Peking University Third Hospital, Tianjin First Central Hospital, Tianjin Huanhu Hospital, Hebei Medical University Third Hospital, The Second Hospital of Hebei Medical University, Hebei General Hospital, Second Hospital of Shanxi Medical University, Shandong Provincial Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Soochow University, Nanjing PLA General Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Minhang Central Hospital, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Guangzhou First People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University, Tongji Hospital, The Central Hospital of Lishui City, Shanghai Pudong New Area People's Hospital, Inner Mongolia Baogang Hospital, Daqing Oil Field Hospital
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 24 Jul 2020 (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 purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.
Detailed description
The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have been well documented in four animal models of stroke. Notable Safety of Neu2000 has been demonstrated in 168 human subjects conducted in the US and China as well as animals.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neu2000KWL 2750mg dose group | Experimental | Drug: Neu2000KWLLow dose group |
| Neu2000KWL 5250mg dose group | Experimental | Drug: Neu2000KWLMiddle dose group |
| Neu2000KWL 6000mg dose group | Experimental | Drug: Neu2000KWLHigh dose group |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patients aged between 35 and 75 years;
- acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;
- patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;
- 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;
- Informed consent should be signed from the patient or patient's legally authorized representative;
Key exclusion criteria (26 listed)
- Any contraindication to CT and MRI (e.g., metal implants such as pacemakers, claustrophobia);
- Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);
- Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;
- Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;
- 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;
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 |
|---|---|---|
| Neu2000KWLAlso: Salfaprodil for injection1st 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 | Drug | Neu2000KWL 2750mg dose group |
| Neu2000KWLAlso: Salfaprodil for injection1st 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 | Drug | Neu2000KWL 5250mg dose group |
| Neu2000KWLAlso: Salfaprodil for injection1st 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 | Drug | Neu2000KWL 6000mg dose group |
| Placebos1st 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 | Drug | Placebo |
Primary outcome
The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.
Time frame: days:14±2
The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.
3 secondary outcomes
Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection. 1. Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Time frame: days 14±2, 30±2 and 90±7
Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Time frame: days 14±2, 30±2 and 90±7
Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.
Time frame: days 14±2, 30±2 and 90±7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- 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.
Meng Wang, MD, Ph.D study director
IRB of Beijing Tiantan Hospital, Capital Medical University
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 Neu2000KWL in people with Stroke and Cerebral Infarction, run by Beijing Tiantan Hospital 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 10 inclusion and 26 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: finished, as of the sponsor's last update on 24 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection. (time frame: days:14±2). 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 24 Jul 2020.