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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: Clinical Trial Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Power spectral analysis identifies differences in Blood Oxygen Level Dependent (BOLD) changes between different cortical areas, cognitive states, or frequency bands that may reflect a pattern of component frequencies. The power spectrum graph shows the BOLD signal's power density over multiple frequencies, measured in Hz/100. Power Spectrum (PS) is the sum of the PS of the SzNET independent components normalized by their spatial volumes. Functional scans were co-registered to the anatomical T1 i
Interventions
- DRUG Levetiracetam
- DRUG Phenobarbital Sodium Injection
- DRUG Fosphenytoin
- DRUG Lacosamide Injectable Product
- DRUG Valproate Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2025-01-22 |
| Phase | Phase 4 |
Why NCT06081283 stopped before completion
NCT06081283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Levetiracetam is the first listed.
NCT06081283 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06081283's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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