PG2 Injection 500 mg in Acute Stroke Study (Pass) "Pass"

Active, not recruiting

Phase 2 Results N/A

Trial Description

The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.
The secondary objectives are as follows:
- To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
- To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
- To evaluate the safety of PG2 Injection 500 mg treatment

Detailed Description

Randomized, double-blind, placebo-controlled multi-center study of intravenous (IV) PG2 Injection 500 mg starting within 3-6 hrs of the onset of acute ischemic stroke

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Placebo
  • PG2 Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: PG2
    ARM 2: Kind: Experimental
    Label: PG2 Injection 500 mg
    Description: PG2 Injection 500 mg

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary efficacy variable is the percentage of patients who are categorized as good functional outcome with mRS <2 90 days No
Secondary Percentage of patients who achieve a Day 90 BI score of 95-100 Percentage of patients who are free of recurrent stroke, cardiovascular events and death of all causes. Percentage of patients who are free of adverse events 90 days Yes

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