RECRUITING

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-18
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06866691

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and older
  2. * Diagnosis of moderate to severe traumatic brain injury
  3. * Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury
  4. * Patients admitted into the trauma team service
  1. * Patients on anti-seizure or anti-epileptic medication
  2. * History of seizures, witnessed or activity of seizure before prophylaxis medication started
  3. * Received anti-seizure medication before randomized into the study
  4. * Patients with a history of alcohol withdrawal or experiencing alcohol withdrawal that require medication treatment
  5. * Spinal cord injury, history of bradycardia or permanent pacemaker, end stage renal disease
  6. * Transferred form an outside hospital \>24 hours from injury and/or given or unconfirmed anti-seizure medication at other hospital
  7. * Death, withdrawal of life support or transfer to hospice within 24 hours of injury
  8. * Special population (pregnant, incarcerated)
  9. * Informed consent not obtained within 72 hours from injury

Contacts and Locations

Study Contact

Kayla McMillan, MS
CONTACT
704-446-5756
kayla.mcmillan@atriumhealth.org
Rita Brintzenhoff, MD
CONTACT
704-446-5756
rita.brintzenhoff@atriumhealth.org

Principal Investigator

Rita Brintzenhoff, MD
PRINCIPAL_INVESTIGATOR
Atrium Health Carolina Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-18
Study Completion Date2026-04

Study Record Updates

Study Start Date2025-04-18
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Brain Injury
  • Post-Traumatic Seizures
  • Seizure Medication

Additional Relevant MeSH Terms

  • Traumatic Brain Injury