Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide (SEIZE-TBI)

April 21, 2026 updated by: Wake Forest University Health Sciences

Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Rita Brintzenhoff, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: levetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
Drug: levetiracetam
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
Other Names:
  • Keppra
Experimental: lacosamide
lacosamide 200 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
Other Names:
  • Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Early Post-traumatic Seizure
Time Frame: Up to day 7 post injury
Number of early post-traumatic seizures documented
Up to day 7 post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hour 24, hour 48, day 7 and day 10 post first drug administration
Administration of Agitation Medications
Time Frame: Hour 24, hour 48, day 7 and day 10
Use of as needed or scheduled agitation medications
Hour 24, hour 48, day 7 and day 10
Incidence of Late Post-traumatic Seizures
Time Frame: Day 8 post injury through day 30
Number of late post-traumatic seizures
Day 8 post injury through day 30
Intensive Care Unit Length of Stay
Time Frame: Admission through day 30
Number of days participant spent in Intensive Care Unit
Admission through day 30
Number of Readmissions to Intensive Care Unit
Time Frame: Admission through day 30
Number of times patient is readmitted to the Intensive Care Unit
Admission through day 30
Total Hospital Length of Stay
Time Frame: Admission through day 30
Number of days participant was admitted to the hospital
Admission through day 30
Duration of Mechanical Ventilation
Time Frame: Admission through day 30
Length of time participant was on mechanical ventilation
Admission through day 30
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
Admission through day 30
Number of In-hospital Mortalities
Time Frame: Admission through day 30
Number of participant mortalities while admitted to hospital
Admission through day 30
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
Admission through day 30
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
Admission through day 30
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
Admission through day 30
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
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Rita Brintzenhoff, MD, 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 Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00123210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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