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Antiseizure Medication

Antiseizure Medication for Severe Brain Injury

Phase 4

Recruiting

Led By Emilio G. Cediel, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Acute brain injury by TBI, hypoxic-ischemic insult, cardiac arrest, or stroke by medical chart review

Must not have

Previous medical history of Epilepsy by medical chart review

Previous medical history of neurological sequels that lead to dependence on care for basic daily activities, by Barthel index score less than 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will explore how antiseizure drugs affect brain connectivity in severe brain injury patients with suppressed consciousness. They will compare pre & post-treatment brain scans to see if seizure networks change.

Who is the study for?

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.

What is being tested?

The study tests if FDA-approved antiseizure medications can change how seizure networks in the brain connect after serious injury. Patients' brains are scanned before and after treatment using rs-fMRI to see if there's any difference in these connections.

What are the potential side effects?

Possible side effects from the antiseizure medications include dizziness, sleepiness, coordination problems, skin rashes or other allergic reactions. Each drug has its own set of potential side effects that could affect different parts of the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an acute brain injury from a trauma or lack of oxygen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My medical records show a history of epilepsy.

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I need help with daily activities due to a neurological condition.

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I do not have allergies or conditions that prevent me from taking the trial drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the second rs-fmri acquisition time limit which means from 0 to 19 days from enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pre and post-intervention seizure networks power spectrum medians

Pre and post-intervention seizure networks total volume medians

Secondary study objectives

Connectivity improvement of typical resting state networks after intervention

Dropout rate

Enrollment rate

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Seizure network Positive subjectsExperimental Treatment5 Interventions

Participants in this group include all SzNET-Positive subjects, whether EEG-Positive or EEG-Negative. Within six days of their initial rs-fMRI study, they will receive both loading and maintenance doses of two intervention drug regimens from the study's list. For participants with a GCS of 9 to 12, the research team will choose one of the two selected ASMs, and will omit its loading dose. Maintenance doses should be administered every 12 hours, starting 12 hours after the loading dose, with a maximum of 19 doses allowed. A second rs-fMRI and EEG will occur after participants have received at least five maintenance doses. Following these assessments, the use of the intervention drugs as part of the research intervention will cease. However, if medically necessary, these drugs can continue as part of regular therapy. Note that repeat EEG and rs-fMRI assessments Must occur no longer than 72 hours after the last dose of the intervention drug regimen.

Group II: Seizure network Negative subjectsActive Control1 Intervention

Participants in this group encompass all SzNET-Negative subjects, including those who are EEG-Positive and EEG-Negative. These participants will not receive interventions after the initial study indicated rs-fMRI. They will neither receive repeat rs-fMRI or repeat EEG.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Valproate Sodium

2019

Completed Phase 3

~40

Levetiracetam

2017

Completed Phase 4

~3650