What side effects are associated with this type of intervention?

Levetiracetam, commonly used for treating neonatal seizures, is generally well-tolerated but can cause side effects such as irritability, somnolence, and gastrointestinal issues. Phenobarbital, another common treatment, can lead to sedation, respiratory depression, and potential long-term neurodevelopmental impacts. Both medications require careful monitoring to balance efficacy and safety in neonates.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of neonatal seizures, with a focus on those that modulate neurotransmitter release. Phenobarbital (PHB) is one of the most commonly used and studied antiepileptic drugs for neonatal seizures. It enhances GABA-mediated inhibition, which helps to control seizure activity. Levetiracetam (LEV), which is being studied for its efficacy in neonatal seizures, is another drug that modulates neurotransmitter release by binding to the synaptic vesicle protein SV2A, thereby preventing seizures. While Levetiracetam is widely used in pediatric and adult epilepsy, its specific use in neonates is still under investigation to determine the optimal dosing and safety profile.

What other types of research exist?

Promising novel alternatives to Levetiracetam for neonatal seizures include Stiripentol, which enhances GABAergic transmission, and Cannabidiol (CBD), which has shown efficacy in drug-resistant epilepsy. Both have been studied in pediatric populations and may offer new options for neonatal seizure management.

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Antiepileptic

Levetiracetam for Neonatal Seizures (NEOLEV3 Trial)

Phase 2

Recruiting

Led By Cynthia M Sharpe, M.D.

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the safest and most effective dose of Levetiracetam (LEV) for treating seizures in newborns. LEV works by calming the brain's electrical activity to prevent or reduce seizures. Newborns with seizures will receive LEV, and if seizures continue, they will be given higher doses of LEV. Levetiracetam (LEV) has been studied extensively for its efficacy and safety in treating seizures across various age groups, including neonates, infants, children, and adults.

Who is the study for?

This trial is for term neonates (newborns aged less than 28 days) weighing over 2200g, with a variety of seizure causes. It's not for those with severe seizures or correctable metabolic issues like low blood sugar/calcium, or kidney failure.

What is being tested?

The study tests the safest high dose of Levetiracetam (LEV) for treating newborn seizures compared to Phenobarbital Sodium (PHB). Babies will be monitored and randomly given either LEV or PHB if their seizures continue after an initial LEV dose.

What are the potential side effects?

Possible side effects include sleepiness, changes in behavior, digestive discomfort, and potential allergic reactions. The exact side effects in newborns are being studied as part of this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Levetiracetam

Secondary study objectives

Adverse event rates

Estimate of efficacy of higher dose LEV

Levetiracetam CL

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dose escalation with LEVExperimental Treatment1 Intervention

Additional LEV at a higher dose (30 mg/kg, 60 mg/kg, or 90 mg/kg depending on the stage of the study).

Group II: Standard of care PhenobarbitalActive Control1 Intervention

Treatment with Phenobarbital 20mg/kg IV and if needed a further 20mg/kg totalling 40mg/kg

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Levetiracetam, a common treatment for neonatal seizures, works by modulating neurotransmitter release through binding to the synaptic vesicle protein SV2A. This action helps stabilize neuronal activity and prevent seizures. This mechanism is particularly important for neonatal seizure patients because their developing brains are highly susceptible to excitatory imbalances, which can lead to frequent and severe seizures. By targeting the neurotransmitter release process, Levetiracetam offers a targeted approach to reduce seizure activity with potentially fewer side effects compared to traditional anticonvulsants like phenobarbital, which work by enhancing inhibitory neurotransmission broadly and can have more sedative effects.