Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

NCT06866691 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB00123210
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 traumatic brain injury requiring seizure prophylaxis.

Conditions

Traumatic Brain Injury

Keywords

Brain Injury; Post-Traumatic Seizures; Seizure Medication

Outcome Measures

Primary Outcomes (1)

• Incidence of Early Post-traumatic Seizure

  Number of early post-traumatic seizures documented

  Up to day 7 post injury

Secondary Outcomes (13)

• Richmond Agitation-Sedation Scale Score Attainment

  Hour 24, hour 48, day 7 and day 10 post first drug administration

• Administration of Agitation Medications

  Hour 24, hour 48, day 7 and day 10

• Incidence of Late Post-traumatic Seizures

  Day 8 post injury through day 30

• Intensive Care Unit Length of Stay

  Admission through day 30

• Number of Readmissions to Intensive Care Unit

  Admission through day 30

Study Arms (2)

levetiracetam

EXPERIMENTAL

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

Drug: levetiracetam

lacosamide

EXPERIMENTAL

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

Drug: lacosamide

Interventions

levetiracetam DRUG

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

Also known as: Keppra

levetiracetam

lacosamide DRUG

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

Also known as: Vimpat

lacosamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Levetiracetam; Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rita Brintzenhoff, MD

  Atrium Health Carolina Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bailey Baswell, BS

CONTACT

704-446-88221; bailey.baswell@advocatehealth.org

Rita Brintzenhoff, MD

CONTACT

704-446-5756; Rita.Brintzenhoff@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)