Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04486430 | Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset | PHASE2 | COMPLETED | 236 | — | — | Mar 2, 2017 | Dec 13, 2019 | Jul 24, 2020 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Neu2000KWL 2750mg dose group | EXPERIMENTAL | Low dose group |
| Neu2000KWL 5250mg dose group | EXPERIMENTAL | Middle dose group |
| Neu2000KWL 6000mg dose group | EXPERIMENTAL | High dose group |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Neu2000KWL | DRUG | 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 |
| Placebos | DRUG | 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 |
Inclusion Criteria: 1. patients aged between 35 and 75 years; 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 ons...