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Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

NCT06866691 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

DRUG

levetiracetam

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

DRUG

lacosamide

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Rita Brintzenhoff, MD · Atrium Health Carolina Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866691 on ClinicalTrials.gov