Compound Edaravone Injection for Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;
2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.

Conditions

Interventions

  • Compound Edaravone Injection Drug
    ARM 1: Kind: Experimental
    Label: Low-dose group
    Description: Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
    ARM 2: Kind: Experimental
    Label: Medium-dose group
    Description: Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
    ARM 3: Kind: Experimental
    Label: High-dose group
    Description: Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
  • Edaravone Injection Drug
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Edaravone Injection´╝î30 mg/dose, one dose every 12 hours, continues for 14 days

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 mRS score on day 90 day 90 No
Primary Change from baseline NIHSS score on day 14 day 14 No
Secondary The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 day 14, 30, 90 No
Secondary The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90 day 14, 30, 90 No
Secondary The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 day 14, 30, 90 No
Secondary Stroke Impact Scale (SIS) score on day 90 day 90 No

Sponsors