drugset / Trial / NCT01458522
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
RandomizedCrossoverSingle-blindTreatment
Summary
This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events profile of LCM compared with fPHT when used to treat frequent NCSs, and length of stay in an intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The trial will include a preacute-treatment period, an acute-treatment period, a postacute-treatment period, and a long-term follow-up period.
Timeline
- Start
- 2012-05
- Primary completion
- 2014-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosphenytoin | Small molecule | 5 mg/kg | Intravenous |
| Subject | Lacosamide | Other / unclassified | 200 mg | Intravenous |
| Subject | Lacosamide | Other / unclassified | 300 mg | Intravenous |