Levetiracetam + Lacosamide for Seizure Prevention
(SEIZE-TBI Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRita Brintzenhoff, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with moderate to severe traumatic brain injury who need treatment to prevent seizures. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or medications that could interfere with the study.

Inclusion Criteria

Patients admitted into the trauma team service

I started seizure prevention medication within a day after my injury.

I am 18 years old or older.

See 1 more

Exclusion Criteria

Patients with a history of alcohol withdrawal or experiencing alcohol withdrawal that require medication treatment

Death, withdrawal of life support or transfer to hospice within 24 hours of injury

Special population (pregnant, incarcerated)

See 6 more

Treatment Details

Interventions

Lacosamide (Anti-epileptic)
Levetiracetam (Anti-epileptic)

Trial OverviewThe trial is testing two drugs, levetiracetam and lacosamide, to see which one better prevents seizures after a traumatic brain injury. It will also compare how each drug affects patients' agitation and behavior.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: levetiracetamExperimental Treatment1 Intervention

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

Group II: lacosamideExperimental Treatment1 Intervention

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