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NCT06081283 · ClinicalTrials.gov registry record · Phase 4

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
Phase 4
Development phase
5
Enrollment target

NCT06081283 is a Phase 4 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 5 participants.

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The verdict

NCT06081283, a Phase 4 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
Phase 4
Development phase
5 participants
Enrollment target

Study 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.

Interventions

  • DRUG Levetiracetam
  • DRUG Phenobarbital Sodium Injection
  • DRUG Fosphenytoin
  • DRUG Lacosamide Injectable Product
  • DRUG Valproate Sodium

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2023-11-20
Est. Completion 2025-01-22
Phase Phase 4

What the Registry Record Tells You About NCT06081283

The ClinicalTrials.gov registry entry for NCT06081283 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Levetiracetam is the first listed.

NCT06081283 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06081283 about?

NCT06081283 is a clinical study titled "Antiseizure Medication in Seizure Networks at Early Acute Brain Injury". 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 ...

What is the current status of trial NCT06081283?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2023-11-20. Estimated completion is 2025-01-22.

What interventions are being tested in trial NCT06081283?

The interventions under investigation include: Levetiracetam (DRUG), Phenobarbital Sodium Injection (DRUG), Fosphenytoin (DRUG), Lacosamide Injectable Product (DRUG), Valproate Sodium (DRUG).

Who is sponsoring clinical trial NCT06081283?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.