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 reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.

Conditions

Interventions

Trial Design

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

Patient Involvement

Patients will be randomized to receive a one hour loading dose of NXY-059 followed by 71 hours of hourly infusion, or placebo.

Outcomes

Type Measure Time Frame Safety Issue
Primary Overall recovery and recovery of motor function at 90 days as measured by the modified Rankin Scale.
Primary Global disability on modified Rankin scale at 90 days.
Secondary NIH stroke scale (termed "co-primary" in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes.

Sponsors