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Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Study acronym: SEIZE-TBI
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 5 words
    • Study description shortened, about 3 words
    v4
  2. Primary and study completion dates: Apr 2026 to Apr 2027
    • Eligibility criteria expanded, about 86 words
    • Site contact updated
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Apr 18, 2025
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06866691
Lead Sponsor Wake Forest University Health Sciences
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Brain Injuries, Traumatic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov