Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Intravenous Magnesium Sulfate in Acute Stroke

Completed

Phase 3 Results

Trial Description

To assess the safety and feasibility of magnesium therapy.

Interventions

  • Magnesium Drug
    Intervention Desc: Ion channel blocker (blocks voltage gated calcium channels and NMDA receptors)

Trial Design

Randomized, double-blind, placebo-controlled pilot trial involving 60 patients at a single center.

Patient Involvement

Sixty patients were randomized to magnesium sulfate (8 mmol IV over 15 minutes followed by 65 mmol over 24 hours) or placebo. Pulse, blood pressure, and serum magnesium levels were monitored.

Outcomes

Type Measure Time Frame Safety Issue
Primary Death or significant functional impairment (Barthel Index score <60) at 3 months.
Secondary Barthel Index, Rankin Scale and NIH Stroke Scale at 5 and 90 days and 10m walking time at 3 months.