Preventing seizures in traumatic brain injury using two medications
Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide
This study tests which of two medications, levetiracetam or lacosamide, is better at preventing seizures in people with moderate to severe traumatic brain injuries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06866691 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the occurrence of early post-traumatic seizures in patients with moderate to severe traumatic brain injury (TBI) who require seizure prophylaxis. It is a prospective randomized controlled trial comparing the efficacy of two medications, levetiracetam and lacosamide, in preventing seizures and assessing their impact on agitation and behavioral side effects. Patients will be randomized within 24 hours of injury and treated with either medication for a total of 7 days. The study will help determine which medication is more effective in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate to severe traumatic brain injury requiring seizure prophylaxis.
Not a fit: Patients with a history of seizures or those already on anti-seizure medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved seizure prevention strategies for patients with traumatic brain injury.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of levetiracetam and lacosamide in TBI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * Diagnosis of traumatic brain injury: severe, moderate, or mild with high-risk imaging features * Seizure prophylaxis with one of the two study drugs within 24 hours of initial injury * Patients admitted into the trauma team service Exclusion Criteria: * Enrolled in another interventional drug study * Any active, witnessed, or unable to rule out seizure prior to prophylaxis initiation * Received antiseizure medication (ASM), for prophylaxis or treatment, prior to randomization * History of seizures * On anti-epileptic medications for seizures or indications other than seizures prior to admission * Documented history of alcohol withdrawal and experiencing alcohol withdrawal on admission with initiation of clinical institute withdrawal assessment scale revised (CIWA-Ar) or modified Minnesota Detoxification Scale (mMINDS) requiring treatment * Spinal cord injury (SCI), confirmed by radiographic imaging demonstrating cervical (C1 to C8) or thoracic-spine (T1 to T12) injuries consistent with spinal cord injury * History of bradycardia or permanent pacemaker or signs of bradycardia with HR \< 55 bpm for \> 5 min not on medications that cause bradycardia * End-stage renal disease (ESRD) * Death, withdrawal of life support or transfer to hospice within 24 hours * Pregnant or incarcerated * Baseline GCS \< 13 or unable to determine baseline GCS * Patient with a GCS of 15 or Legally Authorize Representative (LAR) unable to provide informed consent prior to randomization, or unable to read and understand English, Spanish, Vietnamese, Russian, Arabic, or French
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rita Brintzenhoff, MD — Atrium Health Carolina Medical Center
- Study coordinator: Bailey Baswell, BS
- Email: bailey.baswell@advocatehealth.org
- Phone: 704-446-88221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.