Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke and its PK/PD characteristics in patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose group (The KPCXM18 injection) | Experimental | Intravenous infusion of 20 mg twice daily at intervals of 12±2 hours for 10 days. |
|
| middle-dose group (The KPCXM18 injection) | Experimental | Intravenous infusion of 60 mg twice daily at intervals of 12±2 hours for 10 days. |
|
| high-dose group (The KPCXM18 injection) | Experimental | Intravenous infusion of 100 mg twice daily at intervals of 12±2 hours for 10 days. |
|
| Placebo | Placebo Comparator | Intravenous infusion twice a day with an interval of 12±2 hours for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The KPCXM18 injection | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIHSS score from baseline at day 10 after administration | The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function. | day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with mRS score ≤ 1 at day 90±7 after administration | The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function. | day 90±7 |
| Change in BI score from baseline at day 90±7 after administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duo Gao, bachelor | Contact | 0871-68319868-3052 | duo.gao@kpc.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous infusion |
|
The Barthel Index score ranges from 0 to 100, the higher scores mean a better outcome.
| day 90±7 |
| Change in EQ-5D score from baseline at day 90±7 after administration | day 90±7 |
| Changes in NIHSS score from baseline on days 30±3 and 90±7 after administration | The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function. | days 30±3 and 90±7 |
| Changes in mRS score from baseline on days 30±3 and 90±7 after administration | The Modified Rankin Scale(mRS) score ranging from 0-5. Higher score indicates worse function. | days 30±3 and 90±7 |
| The proportion of subjects whose NIHSS score improved by ≥4 points at days 10, 30±3 and 90±7 after administration | The National Institute of Health stroke scale(NIHSS) score ranging from 0-42. Higher score indicates worse function. | days 10, 30±3 and 90±7 |
| Proportion of subjects with recurrence of stroke within 90±7 days after administration | within 90±7 days |
| Changes in serum biomarkers (TNF-α, MMP9, CHE, IL-10, S100-β) from baseline on day 7 after administration | day 7 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |