Traumatic Brain InjuryPhase 4SEIZE-TBINCT06866691
Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide
A Phase 4 study testing levetiracetam and lacosamide in people with Traumatic Brain Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- levetiracetam and lacosamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Bailey Baswell, BS, 704-446-8221, bailey.baswell@advocatehealth.org
Rita Brintzenhoff, MD
About this study
Official title: Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide
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.
Read the detailed description
This is a prospective randomized controlled trial of patients with TBI requiring seizure prophylaxis to prevent early and late posttraumatic seizures. Patients will be identified and randomized as soon as possible, within 24 hours, from injury and started on seizure prophylaxis if they meet the predefined inclusion and exclusion criteria. Patients randomized to the levetiracetam group will receive levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days. Patients randomized to the lacosamide group will receive lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days.
- Conditions
- Traumatic Brain Injury
- Being tested
- levetiracetam, lacosamide
- Keywords
- Brain Injury, Post-Traumatic Seizures, Seizure Medication
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Also called Keppra
levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days
lacosamideDrug
Also called Vimpat
lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days
| Study group | Role | What they receive |
|---|---|---|
| levetiracetam | Experimental | levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days Receives: Drug: levetiracetam |
| lacosamide | Experimental | lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days Receives: Drug: lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Post-traumatic Seizure
Number of early post-traumatic seizures documented
Measured: Up to day 7 post injury
Secondary outcomes (13)
Richmond Agitation-Sedation Scale Score Attainment
It will be noted if the participant attains their Richmond Agitation-Sedation Scale (RASS) score goal within the various time periods. Goal scores will vary per participant from -5 to +1, depending on individualized sedation goals. If participants are not maintained within their RASS goal and must receive as-needed or scheduled agitation medications to attain their RASS goal, they will be considered to have agitation.
Measured: Hour 24, hour 48, day 7 and day 10 post first drug administration
Administration of Agitation Medications
Use of as needed or scheduled agitation medications
Measured: Hour 24, hour 48, day 7 and day 10
Incidence of Late Post-traumatic Seizures
Number of late post-traumatic seizures
Measured: Day 8 post injury through day 30
Intensive Care Unit Length of Stay
Number of days participant spent in Intensive Care Unit
Measured: Admission through day 30
Number of Readmissions to Intensive Care Unit
Number of times patient is readmitted to the Intensive Care Unit
Measured: Admission through day 30
Total Hospital Length of Stay
Number of days participant was admitted to the hospital
Measured: Admission through day 30
Duration of Mechanical Ventilation
Length of time participant was on mechanical ventilation
Measured: Admission through day 30
Total Cost of Hospitalization
Cost of hospitalization data will be obtained from Surgical Trauma Intensive Care Unit data mart from the Acute Care Surgery Department
Measured: Admission through day 30
Number of In-hospital Mortalities
Number of participant mortalities while admitted to hospital
Measured: Admission through day 30
Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management
Of participants who developed a posttraumatic seizure, number of patients who required operative neurosurgery interventions
Measured: Admission through day 30
Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma
Of participants who developed a posttraumatic seizure, number of patients who had subdural hematomas
Measured: Admission through day 30
Incidence of Agitation Medication Use - Non-intubated Patients
Incidence of agitation medication use (as-needed or scheduled) in non-intubated patients will be assessed via chart review
Measured: Admission through day 30
Post-traumatic Seizure with Anti-Seizure Medication
Number of participants who received anti-seizure medication within four hours vs 5-24 hours from injury
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start18 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Brintzenhoff, MD, Principal investigator, Atrium Health Carolina Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866691
- Sponsor's protocol ID
- IRB00123210
- Acronym
- SEIZE-TBI
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizure Prevention in Traumatic Brain Injury: A Comparative Effectiveness Study of Levetiracetam and Lacosamide
- ClinicalTrials.gov ID
- NCT06866691
- Acronym / sponsor ID
- SEIZE-TBI / IRB00123210
- Conditions
- Traumatic Brain Injury
- Keywords
- Brain Injury, Post-Traumatic Seizures, Seizure Medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective randomized controlled trial of patients with TBI requiring seizure prophylaxis to prevent early and late posttraumatic seizures. Patients will be identified and randomized as soon as possible, within 24 hours, from injury and started on seizure prophylaxis if they meet the predefined inclusion and exclusion criteria. Patients randomized to the levetiracetam group will receive levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days. Patients randomized to the lacosamide group will receive lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levetiracetam | Experimental | Drug: levetiracetamlevetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days |
| lacosamide | Experimental | Drug: lacosamidelacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levetiracetamAlso: Keppralevetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days | Drug | levetiracetam |
| lacosamideAlso: Vimpatlacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days | Drug | lacosamide |
Primary outcome
Incidence of Early Post-traumatic Seizure
Time frame: Up to day 7 post injury
Number of early post-traumatic seizures documented
13 secondary outcomes
Richmond Agitation-Sedation Scale Score Attainment
Time frame: Hour 24, hour 48, day 7 and day 10 post first drug administration
Administration of Agitation Medications
Time frame: Hour 24, hour 48, day 7 and day 10
Incidence of Late Post-traumatic Seizures
Time frame: Day 8 post injury through day 30
Intensive Care Unit Length of Stay
Time frame: Admission through day 30
Number of Readmissions to Intensive Care Unit
Time frame: Admission through day 30
Total Hospital Length of Stay
Time frame: Admission through day 30
Duration of Mechanical Ventilation
Time frame: Admission through day 30
Total Cost of Hospitalization
Time frame: Admission through day 30
Number of In-hospital Mortalities
Time frame: Admission through day 30
Post-traumatic Seizure - Operative vs Nonoperative Neurosurgery Management
Time frame: Admission through day 30
Post-traumatic Seizure - Subdural Hematoma vs Non-subdural Hematoma
Time frame: Admission through day 30
Incidence of Agitation Medication Use - Non-intubated Patients
Time frame: Admission through day 30
Post-traumatic Seizure with Anti-Seizure Medication
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Brintzenhoff, MD principal investigator
Atrium Health Carolina Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levetiracetam and lacosamide in people with Traumatic Brain Injury, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bailey Baswell, BS (704-446-88221, bailey.baswell@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early Post-traumatic Seizure (time frame: Up to day 7 post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.