Comparison of Levetiracetam Versus Lacosamide for Seizure Prevention in Moderate to Severe Traumatic Brain Injured Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 moderate to severe traumatic brain injury requiring seizure prophylaxis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years and older
• Diagnosis of moderate to severe traumatic brain injury
• Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury
• Patients admitted into the trauma team service
Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Kayla McMillan, MS
kayla.mcmillan@atriumhealth.org
704-446-5756
Backup
Rita Brintzenhoff, MD
rita.brintzenhoff@atriumhealth.org
704-446-5756
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2026-04
Participants
Target number of participants: 600
Treatments
Experimental: levetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
Experimental: lacosamide
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences