Antiseizure Medication for Severe Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how antiseizure medications affect brain activity in patients with severe brain injuries and impaired consciousness. Researchers seek to determine if these medications can alter the brain's seizure networks, which might cause seizures, using special brain scans called rs-fMRI. Patients in the ICU who have recently suffered a severe brain injury, such as a stroke or trauma, might be suitable candidates. Participants will take two antiseizure drugs, including Lacosamide Injectable Product (Vimpat) and Levetiracetam, and undergo brain scans before and after to check for changes. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they can benefit more patients.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, if you have known allergies or contraindications to the trial's antiseizure medications, you may not be eligible to participate.
What is the safety track record for these treatments?
A previous study found lacosamide safe for treating seizures, even after traumatic brain injury, without harming cognitive skills. Research suggests it may protect the brain if administered before oxygen loss, as demonstrated in studies with newborn rats.
Levetiracetam, another seizure medication, is often used for traumatic brain injuries. It is safe, commonly used in trauma centers to prevent seizures, and performs well compared to similar drugs.
Phenobarbital is recommended for managing brain injuries, particularly to reduce intracranial pressure. It can be used without worsening confusion and may decrease the need for other sedatives.
Phosphenytoin effectively prevents early seizures after traumatic brain injury, especially in adults. Studies show it reduces the risk of seizures soon after the injury.
Valproate sodium may help protect the brain post-injury by reducing brain cell damage and aiding recovery. However, rare cases of nerve damage have occurred, necessitating careful monitoring.
All these medications are FDA-approved for other uses, indicating they are generally well-tolerated. However, like any medication, side effects can occur, so participants are closely monitored during trials.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments because they explore various antiseizure medications to manage seizures after severe brain injury. Unlike some standard treatments, such as carbamazepine or topiramate, which have been commonly used for seizures, this trial includes drugs like lacosamide and levetiracetam, each with unique mechanisms of action. Lacosamide, for instance, stabilizes neuronal membranes by enhancing the slow inactivation of sodium channels, offering a potentially different approach to controlling post-injury seizures. Additionally, the injectable formulations of these treatments allow for rapid administration, which is crucial in acute care settings. This trial aims to determine the effectiveness of these drugs in a specific subgroup of patients, helping to refine and optimize treatment strategies for better outcomes.
What evidence suggests that this trial's antiseizure medications could be effective for severe brain injury?
Research shows that these FDA-approved seizure medications can help reduce seizures in people with brain injuries. In this trial, participants in the Seizure Network Positive group will receive two of these medications. Lab studies have found that lacosamide may protect brain cells after an injury. Levetiracetam is considered safe and works like phenytoin to prevent seizures soon after a brain injury. Phenobarbital can decrease pressure inside the skull, which may help after severe injuries, but it might also cause changes in blood pressure. Fosphenytoin is similar to levetiracetam in preventing seizures, especially in young children with brain injuries. Lastly, valproate sodium can lower the risk of early seizures after a severe brain injury and might help protect the brain from further harm. Studies support these treatments, showing their effectiveness in managing seizures after brain injuries.24678
Who Is on the Research Team?
Emilio G. Cediel, MD
Principal Investigator
UNC-Chapel Hill
Varina L Boerwinkle, MD
Principal Investigator
UNC-Chapel Hill
Are You a Good Fit for This Trial?
This trial is for ICU patients with severe brain injuries from events like stroke or cardiac arrest, who are stable enough for an MRI but have a Glasgow Coma Scale score under 9. They must be within 3 to 45 days of their injury and not allergic to the study drugs, pregnant, brain dead, have contraindications for MRI scans, epilepsy history, or severe neurological dependence.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants undergo an initial rs-fMRI to identify seizure networks
Treatment
Participants with identified seizure networks receive antiseizure medication and undergo a second rs-fMRI
Follow-up
Participants are monitored for changes in seizure networks and typical resting state networks post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lacosamide Injectable Product
- Levetiracetam
- Phenobarbital Sodium Injection
- Phosphenytoin
- Valproate Sodium
Lacosamide Injectable Product is already approved in European Union, United States, Canada, Japan for the following indications:
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor