Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Phase 4

Recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Drug: levetiracetam; Drug: lacosamide

• Registration Number: NCT06866691
• Lead Sponsor: Wake Forest University Health Sciences

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 moderate to severe traumatic brain injury requiring seizure prophylaxis.

Detailed Description

This is a prospective randomized controlled trial of patients with moderate to severe 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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-10
• Study Start: 2025-04-18
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 18 years and older
• Diagnosis of moderate to severe traumatic brain injury
• Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury
• Patients admitted into the trauma team service

Exclusion Criteria

• Patients on anti-seizure or anti-epileptic medication
• History of seizures, witnessed or activity of seizure before prophylaxis medication started
• Received anti-seizure medication before randomized into the study
• Patients with a history of alcohol withdrawal or experiencing alcohol withdrawal that require medication treatment
• Spinal cord injury, history of bradycardia or permanent pacemaker, end stage renal disease
• Transferred form an outside hospital >24 hours from injury and/or given or unconfirmed anti-seizure medication at other hospital
• Death, withdrawal of life support or transfer to hospice within 24 hours of injury
• Special population (pregnant, incarcerated)
• Informed consent not obtained within 72 hours from injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levetiracetam	levetiracetam	levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
lacosamide	lacosamide	lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days

Primary Outcome Measures

Name	Time	Method
Incidence of Early Post-traumatic Seizure	Up to day 7 post injury	Number of early post-traumatic seizures documented

Secondary Outcome Measures

Name	Time	Method
Richmond Agitation-Sedation Scale Score Attainment	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.
Administration of Agitation Medications	Hour 24, hour 48, day 7 and day 10	Use of as needed or scheduled agitation medications
Incidence of Late Post-traumatic Seizures	Day 8 post injury through day 30	Number of late post-traumatic seizures
Intensive Care Unit Length of Stay	Admission through day 30	Number of days participant spent in Intensive Care Unit
Number of Readmissions to Intensive Care Unit	Admission through day 30	Number of times patient is readmitted to the Intensive Care Unit
Total Hospital Length of Stay	Admission through day 30	Number of days participant was admitted to the hospital
Duration of Mechanical Ventilation	Admission through day 30	Length of time participant was on mechanical ventilation
Total Cost of Hospitalization	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
Number of In-hospital Mortalities	Admission through day 30	Number of participant mortalities while admitted to hospital
Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management	Admission through day 30	Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions
Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma	Admission through day 30	Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas
Incidence of Agitation Medication Use - Non-intubated Patients	Admission through day 30	Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review
Post-traumatic Seizure with Anti-Seizure Medication	Day 7	Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States