Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06866691
Phase
PHASE4
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • levetiracetam — DRUG
    levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
  • lacosamide — DRUG
    lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days

Study Details

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.

Key Dates

Start date
Apr 18, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: levetiracetam
    levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
  • Experimental: lacosamide
    lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days

Primary Outcome Measure

Incidence of Early Post-traumatic Seizure [ Time Frame: Up to day 7 post injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Bailey Baswell, BS
[email protected]
704-446-8221
Rita Brintzenhoff, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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