Recruiting

Levetiracetam & LacosamideSeizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06866691

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

levetiracetam

lacosamide

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Study ID

NCT06866691

Start date

Apr 18, 2025

Status verified date

Apr, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: levetiracetam

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

experimental: lacosamide

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

Interventions

levetiracetam

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

lacosamide

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

Primary outcome measure

Incidence of Early Post-traumatic Seizure [ Time Frame: Up to day 7 post injury ]

Central Contacts and Locations

Central contacts

Bailey Baswell, BS

704-446-88221 bailey.baswell@advocatehealth.org

Rita Brintzenhoff, MD

704-446-5756 Rita.Brintzenhoff@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Bailey Baswell, BS

704-446-8221 bailey.baswell@advocatehealth.org

Principal Investigator:

Rita Brintzenhoff, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

Brain Injury
Post-Traumatic Seizures
Seizure Medication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-24.