Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Last updated: April 23, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Traumatic Brain Injury

Neurologic Disorders

Memory Loss

Treatment

levetiracetam

lacosamide

Clinical Study ID

NCT06866691
IRB00123210
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 initialinjury

  • Patients admitted into the trauma team service

Exclusion

Exclusion Criteria:

  • Patients on anti-seizure or anti-epileptic medication

  • History of seizures, witnessed or activity of seizure before prophylaxis medicationstarted

  • Received anti-seizure medication before randomized into the study

  • Patients with a history of alcohol withdrawal or experiencing alcohol withdrawalthat require medication treatment

  • Spinal cord injury, history of bradycardia or permanent pacemaker, end stage renaldisease

  • Transferred form an outside hospital >24 hours from injury and/or given orunconfirmed anti-seizure medication at other hospital

  • Death, withdrawal of life support or transfer to hospice within 24 hours of injury

  • Special population (pregnant, incarcerated)

  • Informed consent not obtained within 72 hours from injury

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: levetiracetam
Phase: 4
Study Start date:
April 18, 2025
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.