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

Completed

Phase 2 Results

Trial Description

This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.

Conditions

Interventions

Trial Design

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

Patient Involvement

We treated 300 patients with NXY-059 and 303 with placebo. Treatment groups were well matched for prognostic variables including Glasgow Coma Scale, risk factors, and age. The mean National Institute of Health Stroke Scale score on admission was 14 in both groups. The baseline hemorrhage volume was 22.4+/-20.1 mL in the NXY-059 group and 23.3+/-22.8 mL in the placebo group (mean+/-SD). Most hemorrhages were related to hypertension or anticoagulant use. Mortality was similar in both groups: 20.3% for NXY-059 and 19.8% for placebo-treated patients. The proportion of patients who experienced an adverse event was the same for both groups, whereas for serious adverse events the proportion was slightly higher in the NXY-059 group. However, no pattern emerged to indicate a safety concern. Serum potassium fell transiently in both groups, lower in the NXY-059 group. There were no differences in 3-month function, disability, or neurological deficit scores. The odds ratio for an improved outcome in 3-month mRS scores in the NXY-059 group was 1.01 (95% CI 0.75, 1.35). NXY-059 given within 6 hours of acute ICH has a good safety and tolerability profile, with no adverse effect on important clinical outcomes.

Outcomes

Type Measure Time Frame Safety Issue
Primary Assessment of safety and tolerability includes mortality (overall and by cause), incidence of adverse events, change from baseline in imaging scans including volume of ICH, presence of abnormal findings on vital signs, laboratory assessments, and by electrocardiography (ECG).
Secondary Efficacy will be explored using the modified Rankin scale (mRS; global disability), Barthel Index (functional recovery) and NIHSS (neurological recovery) at 90 days or last rating.
Primary Global disability on modified Rankin scale at 90 days
Secondary NIH stroke scale
Secondary Barthel Index
Secondary Stroke Impact Scale

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