Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide (SEIZE-TBI)

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Drug: lacosamide; Drug: levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT06866691

IRB00123210

Details and patient eligibility

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 moderate to severe traumatic brain injury requiring seizure prophylaxis.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

levetiracetam

Experimental group

Description:

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

Treatment:

Drug: levetiracetam

lacosamide

Experimental group

Description:

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

Treatment:

Drug: lacosamide