NCT06866691

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Comparison of Levetiracetam Versus Lacosamide for Seizure Prevention in Moderate to Severe Traumatic Brain Injured Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective randomized controlled trial of patients with moderate to severe 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 a total of 7 days.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	levetiracetam	levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
DRUG	lacosamide	lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days

Timeline

• Start date: 2025-04-18
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-03-10
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study