Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

Completed

Phase 3 Results

Trial Description

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

Patients will be randomized to either the placebo control group or the treatment group to receive a one hour loading dose of NXY-059 followed by 71 hours of hourly infusion to obtain a target unbound plasma concentration of 260 ?mol/L.

Outcomes

Type Measure Time Frame Safety Issue
Primary Overall recovery and recovery of motor function after ischemic stroke as measured by the modified Rankin Scale at 90 days.
Secondary The NIHSS and other efficacy outcomes, including the Barthel Index, will be considered formally significant only if analyses higher in the hierarchy of statistical testing reach significance.
Primary Global disability on modified Rankin scale at 90 days.
Secondary NIH stroke scale
Secondary Barthel Index
Secondary Stroke Impact Scale
Secondary EQ-5D all at 90 days
Secondary Safety outcomes

Sponsors