drugset / Trial / NCT01110187
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fosphenytoin | Small molecule | 5 mg/kg | Intravenous |
| Subject | Lacosamide | Other / unclassified | 100 mg | Intravenous |