Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Description

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.

Conditions

Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

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.

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

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Condition
Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 initial injury
  • * Patients admitted into the trauma team service
  • * Patients on anti-seizure or anti-epileptic medication
  • * History of seizures, witnessed or activity of seizure before prophylaxis medication started
  • * Received anti-seizure medication before randomized into the study
  • * Patients with a history of alcohol withdrawal or experiencing alcohol withdrawal that require medication treatment
  • * Spinal cord injury, history of bradycardia or permanent pacemaker, end stage renal disease
  • * Transferred form an outside hospital \>24 hours from injury and/or given or unconfirmed 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Rita Brintzenhoff, MD, PRINCIPAL_INVESTIGATOR, Atrium Health Carolina Medical Center

Study Record Dates

2026-04