A Phase 4 interventional study of levetiracetam and lacosamide in Traumatic Brain Injury, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Prevention
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.
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's planned enrollment of 600 is above the median of 56 across 1,133 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
Drug: levetiracetam
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Drug: lacosamide
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
Also known as: Keppra
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
Also known as: Vimpat
Incidence of Early Post-traumatic Seizure
Number of early post-traumatic seizures documented
Time frame: Up to day 7 post injury
Richmond Agitation-Sedation Scale Score Attainment
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.
Time frame: Hour 24, hour 48, day 7 and day 10 post first drug administration
Administration of Agitation Medications
Use of as needed or scheduled agitation medications
Time frame: Hour 24, hour 48, day 7 and day 10
Incidence of Late Post-traumatic Seizures
Number of late post-traumatic seizures
Time frame: Day 8 post injury through day 30
Intensive Care Unit Length of Stay
Number of days participant spent in Intensive Care Unit
Time frame: Admission through day 30
Number of Readmissions to Intensive Care Unit
Number of times patient is readmitted to the Intensive Care Unit
Time frame: Admission through day 30
Total Hospital Length of Stay
Number of days participant was admitted to the hospital
Time frame: Admission through day 30
Duration of Mechanical Ventilation
Length of time participant was on mechanical ventilation
Time frame: Admission through day 30
Total Cost of Hospitalization
Cost of hospitalization data will be obtained from Surgical Trauma Intensive Care Unit data mart from the Acute Care Surgery Department
Time frame: Admission through day 30
Number of In-hospital Mortalities
Number of participant mortalities while admitted to hospital
Time frame: Admission through day 30
Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management
Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions
Time frame: Admission through day 30
Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma
Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas
Time frame: Admission through day 30
Incidence of Agitation Medication Use - Non-intubated Patients
Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review
Time frame: Admission through day 30
Post-traumatic Seizure with Anti-Seizure Medication
Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury
Time frame: Day 7
Plan to share: No
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Wake Forest University Health Sciences