Study of ONO-2506 in Patients With Acute Ischemic Stroke

Completed

Phase 2/3 Results N/A

Trial Description

The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.

Conditions

Interventions

  • ONO-2506 (Proglia)Drug
    Intervention Desc: Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
    ARM 1: Kind: Experimental
    Label: E2
    ARM 2: Kind: Experimental
    Label: P
    ARM 3: Kind: Experimental
    Label: E1

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 Modified Rankin Scale at 90 days 90 days No
Secondary Modified Rankin Scale at 30 days 30 days No
Secondary National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days 90 days No

Sponsors