Actively Recruiting
Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
Led by Wake Forest University Health Sciences · Updated on 2026-04-24
600
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Diagnosed with traumatic brain injury, including severe, moderate, or mild with high-risk imaging features
- Will receive seizure prevention treatment with either levetiracetam or lacosamide within 24 hours of injury
- Admitted to the trauma team service
You will not qualify if you...
- Currently enrolled in another interventional drug study
- Had any active or witnessed seizure or seizure cannot be ruled out before starting seizure prevention
- Received antiseizure medication before randomization
- History of seizures
- Taking anti-epileptic medications for seizures or other reasons before admission
- History of alcohol withdrawal or currently experiencing alcohol withdrawal requiring treatment
- Have spinal cord injury confirmed by imaging (cervical C1-C8 or thoracic T1-T12)
- History of slow heart rate (bradycardia), permanent pacemaker, or heart rate under 55 bpm for more than 5 minutes not caused by medication
- End-stage kidney disease
- Death, withdrawal of life support, or transfer to hospice within 24 hours
- Pregnant or incarcerated
- Baseline Glasgow Coma Scale (GCS) below 13 or unable to determine GCS
- Patient or authorized representative unable to provide informed consent before randomization or unable to read and understand English, Spanish, Vietnamese, Russian, Arabic, or French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
B
Bailey Baswell, BS
CONTACT
R
Rita Brintzenhoff, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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