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.
- NXY-059 (Cerovive)Drug
- Allocation: Randomized
- Masking: Double-Blind
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Factorial Assignment
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.
|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||Stroke Impact Scale|
|Secondary||EQ-5D all at 90 days|
- AstraZeneca Lead