NCT06866691 · Wake Forest University Health Sciences
Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
(SEIZE-TBI)
What this study is about
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.
View original scientific 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 traumatic brain injury requiring seizure prophylaxis.
Interventions
DRUG
levetiracetam
levetiracetam 1000 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
Primary outcome measures
Incidence of Early Post-traumatic Seizure
Time frame: Up to day 7 post injury
Number of early post-traumatic seizures documented
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations