drugset / Trial / NCT00004730

Magnesium Sulfate For Brain Injury

NCT00004730 ↗

Phase 3 Completed University of Washington
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a moderate or severe traumatic brain injury improves survival, decreases the number of people developing seizures, improves the survivors' mental and psychological functioning, including the ability to return to daily life, live independently, and return to work or school.

Timeline

Start
1998-08
Primary completion
2005-05
Completion
2005-05

Outcome

Missed primary endpoint

paper Magnesium showed no significant positive effect on the composite primary outcome measure at the higher dose (mean=55 average percentile ranking on magnesium vs 52 on placebo, 95% CI for difference -7 to 14; p=0.70). PMID 17166799 ↗

paper Those randomly assigned magnesium at the lower dose did significantly worse than those assigned placebo (48 vs 54, 95% CI -10.5 to -2; p=0.007). PMID 17166799 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Magnesium Sulfate Other / unclassified 0.24 unknown Intravenous