Clinical trial NCT06866691: Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
Official title: Comparison of Levetiracetam Versus Lacosamide for Seizure Prevention in Moderate to Severe Traumatic Brain Injured Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Traumatic Brain Injury
Keywords: Brain Injury
Post-Traumatic Seizures
Seizure Medication
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Early Post-traumatic Seizure
timeFrame: Up to day 7 post injury
Secondary outcomes:
measure: Richmond Agitation-Sedation Scale Score Attainment
timeFrame: Hour 24, hour 48, day 7 and day 10 post first drug administration
measure: Administration of Agitation Medications
timeFrame: Hour 24, hour 48, day 7 and day 10
measure: Incidence of Late Post-traumatic Seizures
timeFrame: Day 8 post injury through day 30
measure: Intensive Care Unit Length of Stay
timeFrame: Admission through day 30
measure: Number of Readmissions to Intensive Care Unit
timeFrame: Admission through day 30
measure: Total Hospital Length of Stay
timeFrame: Admission through day 30
measure: Duration of Mechanical Ventilation
timeFrame: Admission through day 30
measure: Total Cost of Hospitalization
timeFrame: Admission through day 30
measure: Number of In-hospital Mortalities
timeFrame: Admission through day 30
measure: Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management
timeFrame: Admission through day 30
measure: Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma
timeFrame: Admission through day 30
measure: Incidence of Agitation Medication Use - Non-intubated Patients
timeFrame: Admission through day 30
measure: Post-traumatic Seizure with Anti-Seizure Medication
timeFrame: Day 7
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Atrium Health Carolina Medical Center
name: Rita Brintzenhoff, MD
role: PRINCIPAL_INVESTIGATOR
References: