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Which drug stops TBI seizures best? new study aims to find out

NCT ID NCT06866691

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two common seizure medications, levetiracetam and lacosamide, to see which works better at preventing early seizures after a traumatic brain injury. Researchers will also track side effects like agitation and sedation. The trial plans to enroll 600 adults with moderate to severe brain injuries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
levetiracetam (Keppra) and lacosamide (Vimpat)
What this could lead to
If successful, this could show which drug better prevents early seizures after a traumatic brain injury with fewer behavioral side effects, helping guide standard care.
What could go wrong
This is a phase 4 study comparing two already-approved drugs, so no new treatment is being discovered. Results may not apply to all brain injury patients, and individual responses vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury traumatic brain injury post-traumatic epilepsy prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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