drugset / Trial / NCT01110187

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

NCT01110187

RandomizedParallel-groupSingle-blindPrevention

Summary

Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

Timeline

Start
2010-05
Primary completion
2012-05
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fosphenytoin Small molecule 5 mg/kg Intravenous
Subject Lacosamide Other / unclassified 100 mg Intravenous