Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide
Wake Forest University Health Sciences
Summary
The purpose of this study is to assess the incidence of early post-traumatic seizures. The study will also assess the benefit of lacosamide compared to levetiracetam in regards to agitation and behavioral adverse effects in patients with traumatic brain injury requiring seizure prophylaxis.
Description
This is a prospective randomized controlled trial of patients with TBI requiring seizure prophylaxis to prevent early and late posttraumatic seizures. Patients will be identified and randomized as soon as possible, within 24 hours, from injury and started on seizure prophylaxis if they meet the predefined inclusion and exclusion criteria. Patients randomized to the levetiracetam group will receive levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days. Patients randomized to the lacosamide group will receive lacosamide 200 mg intravenously or by mouth twice daily for…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years and older * Diagnosis of traumatic brain injury: severe, moderate, or mild with high-risk imaging features * Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury * Patients admitted into the trauma team service Exclusion Criteria: * Enrolled in another interventional drug study * Any active, witnessed, or unable to rule out seizure prior to prophylaxis initiation * Received antiseizure medication (ASM), for prophylaxis or treatment, prior to randomization * History of seizures * On anti-epileptic medications for seizures or ind…
Interventions
- Druglevetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
- Druglacosamide
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina