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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01603667 | PG2 Injection 500 mg in Acute Stroke Study (Pass) | PHASE2 | COMPLETED | 86 | — | — | Jun 1, 2012 | Oct 1, 2015 | Nov 4, 2016 | 1 | Taiwan |
| Arm | Type | Description |
|---|---|---|
| PG2 Injection 500 mg | EXPERIMENTAL | PG2 Injection 500 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| PG2 | DRUG | STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days |
| placebo | DRUG | STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5\~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days. ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days |
Inclusion Criteria: 1. Patients presenting with acute ischaemic stroke 2. Patient, or a family member with legally authorized responsibility, has given informed consent 3. Age ≥20 years 4. Infusion of study medication can be started within 3-6 hrs of stroke onset. 5. NIHSS score of ≥ 7 - 24 Exclus...