Preventing seizures in traumatic brain injury using two medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.