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NCT Number: NCT06866691

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

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 traumatic brain injury requiring seizure prophylaxis.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Bailey Baswell, BS

CONTACT

[email protected]

704-446-8221

Rita Brintzenhoff, MD

PRINCIPAL_INVESTIGATOR

About this study

This is a prospective randomized controlled trial of patients with 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Diagnosis of traumatic brain injury: severe, moderate, or mild with high-risk imaging features
  • Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury
  • Patients admitted into the trauma team service

Exclusion criteria

  • Enrolled in another interventional drug study
  • Any active, witnessed, or unable to rule out seizure prior to prophylaxis initiation
  • Received antiseizure medication (ASM), for prophylaxis or treatment, prior to randomization
  • History of seizures
  • On anti-epileptic medications for seizures or indications other than seizures prior to admission
  • Documented history of alcohol withdrawal and experiencing alcohol withdrawal on admission with initiation of clinical institute withdrawal assessment scale revised (CIWA-Ar) or modified Minnesota Detoxification Scale (mMINDS) requiring treatment
  • Spinal cord injury (SCI), confirmed by radiographic imaging demonstrating cervical (C1 to C8) or thoracic-spine (T1 to T12) injuries consistent with spinal cord injury
  • History of bradycardia or permanent pacemaker or signs of bradycardia with HR < 55 bpm for > 5 min not on medications that cause bradycardia
  • End-stage renal disease (ESRD)
  • Death, withdrawal of life support or transfer to hospice within 24 hours
  • Pregnant or incarcerated
  • Baseline GCS < 13 or unable to determine baseline GCS
  • Patient with a GCS of 15 or Legally Authorize Representative (LAR) unable to provide informed consent prior to randomization, or unable to read and understand English, Spanish, Vietnamese, Russian, Arabic, or French

Treatment and study plan

Levetiracetam

Drug

levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days

Other names: Keppra

Lacosamide

Drug

lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days

Other names: Vimpat

Primary outcomes

  1. Incidence of Early Post-traumatic Seizure

    Time frame: Up to day 7 post injury

    Number of early post-traumatic seizures documented

Secondary outcomes

  1. Richmond Agitation-Sedation Scale Score Attainment

    Time frame: Hour 24, hour 48, day 7 and day 10 post first drug administration

    It will be noted if the participant attains their Richmond Agitation-Sedation Scale (RASS) score goal within the various time periods. Goal scores will vary per participant from -5 to +1, depending on individualized sedation goals. If participants are not maintained within their RASS goal and must receive as-needed or scheduled agitation medications to attain their RASS goal, they will be considered to have agitation.

  2. Administration of Agitation Medications

    Time frame: Hour 24, hour 48, day 7 and day 10

    Use of as needed or scheduled agitation medications

  3. Incidence of Late Post-traumatic Seizures

    Time frame: Day 8 post injury through day 30

    Number of late post-traumatic seizures

  4. Intensive Care Unit Length of Stay

    Time frame: Admission through day 30

    Number of days participant spent in Intensive Care Unit

  5. Number of Readmissions to Intensive Care Unit

    Time frame: Admission through day 30

    Number of times patient is readmitted to the Intensive Care Unit

  6. Total Hospital Length of Stay

    Time frame: Admission through day 30

    Number of days participant was admitted to the hospital

  7. Duration of Mechanical Ventilation

    Time frame: Admission through day 30

    Length of time participant was on mechanical ventilation

  8. Total Cost of Hospitalization

    Time frame: Admission through day 30

    Cost of hospitalization data will be obtained from Surgical Trauma Intensive Care Unit data mart from the Acute Care Surgery Department

  9. Number of In-hospital Mortalities

    Time frame: Admission through day 30

    Number of participant mortalities while admitted to hospital

  10. Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management

    Time frame: Admission through day 30

    Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions

  11. Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma

    Time frame: Admission through day 30

    Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas

  12. Incidence of Agitation Medication Use - Non-intubated Patients

    Time frame: Admission through day 30

    Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review

  13. Post-traumatic Seizure with Anti-Seizure Medication

    Time frame: Day 7

    Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury

Study contacts

Contact information is provided by the study sponsor or research team.

Bailey Baswell, BS

CONTACT

[email protected]

704-446-88221

Rita Brintzenhoff, MD

CONTACT

[email protected]

704-446-5756

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide

Acronym: SEIZE-TBI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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