A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

NATerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Traumatic Brain Injury
Interventions
DRUG

lacosamide

200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose.

DRUG

Fosphenytoin

20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days

Trial Locations (3)

45069

UC Health University Pointe, Cincinnati

45219

UC Health Medical Arts Building, Cincinnati

University Hospital, Cincinnati

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

UCB Pharma

INDUSTRY

lead

University of Alabama at Birmingham

OTHER