drugset / Trial / NCT06081283

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

NCT06081283

Phase 4 Terminated 5 enrolled University of North Carolina, Chapel Hill
Non-randomizedSequentialOpen-labelTreatment

Summary

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: * Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? * What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

Timeline

Start
2023-11-20
Primary completion
2024-12-22
Completion
2025-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosphenytoin Small molecule 4 mg/kg Intravenous
Subject Lacosamide Other / unclassified 4 mg/kg Intravenous
Subject Lacosamide Other / unclassified 8 mg/kg Intravenous
Subject Lacosamide Other / unclassified 200 mg Intravenous
Subject Lacosamide Other / unclassified 400 mg Intravenous
Subject Levetiracetam Other / unclassified 40 mg/kg Intravenous
Subject Levetiracetam Other / unclassified 1500 mg Intravenous
Subject Levetiracetam Other / unclassified 3000 mg Intravenous
Subject Phenobarbital Unknown 4 mg/kg Intravenous
Subject Valproate Small molecule 20 mg/kg Intravenous
Subject Valproate Small molecule 30 mg/kg Intravenous