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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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