drugset / Trial / NCT01458522

Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

NCT01458522

Phase 2 Completed 74 enrolled Aatif Husain UCB Pharma · collab
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

EvaluationDrugModalityDoseRoute
Subject Fosphenytoin Small molecule 5 mg/kg Intravenous
Subject Lacosamide Other / unclassified 200 mg Intravenous
Subject Lacosamide Other / unclassified 300 mg Intravenous

Indications