NCT06866691 Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
| NCT ID | NCT06866691 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2025-04-18 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Rita Brintzenhoff, MD
PRINCIPAL INVESTIGATOR
Atrium Health Carolina Medical Center
Frequently Asked Questions
Who can join the NCT06866691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06866691 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06866691 currently recruiting?
Yes, NCT06866691 is actively recruiting participants. Contact the research team at bailey.baswell@advocatehealth.org for enrollment information.
Where is the NCT06866691 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT06866691 clinical trial?
NCT06866691 is sponsored by Wake Forest University Health Sciences. The principal investigator is Rita Brintzenhoff, MD at Atrium Health Carolina Medical Center. The trial plans to enroll 600 participants.