What is Levetiracetam studying for neonatal seizures?

This trial is studying the best dose of Levetiracetam to safely treat seizures in newborns. Researchers want to find out if higher doses than currently used can better control seizures. The study is sponsored by the University of California, San Diego, to improve treatments for babies with seizures.

Who may be eligible for this neonatal seizure clinical trial?

Babies less than 28 days old who are at risk of or have seizures may be eligible. They must be term neonates with a corrected gestational age between 35 and 44 weeks and weigh more than 2200 grams. Babies with seizures caused by correctable metabolic issues or with very high seizure burden may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this neonatal seizure clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants and families should plan accordingly.

Actively Recruiting

Phase 2

Age: 0 - 1Month

All Genders

ID05610085

Phase IIb Study to Find the Safest High Dose of Levetiracetam for Treating Seizures in Newborns

Led by University of California, San Diego · Updated on 2026-06-15

133

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the maximum safe and tolerated dose of Levetiracetam LEV for treating neonatal seizures. This Phase IIb, open-label dose-escalation study aims to determine if higher doses of LEV than currently used can improve seizure control in newborns. The study includes infants at risk or confirmed to have neonatal seizures of mild to moderate severity, with continuous video EEG monitoring used to assess seizure activity and control. Participants initially receive a 60 mgkg dose of LEV. If seizures persist after this dose, they are randomized to either receive higher doses of LEV 90 mgkg, 120 mgkg, or 180 mgkg in increments or treatment with Phenobarbital PHB at 20-40 mgkg. Maintenance treatment with PHB may continue for five days either intravenously or orally if tolerated. The study includes three phases, with Phase 3 expanding to neonates with more severe seizure burden if earlier phases show efficacy. Throughout the study, participants are monitored with continuous EEG reviewed by neurophysiologists to assess seizure control over 24 hours and changes in seizure burden during the two hours after treatment. Safety, pharmacokinetics, seizure freedom rates, adverse events, and long-term outcomes up to eight years are evaluated. The study also assesses new technology for neonatal seizure detection. Participation may last several years due to extended follow-up for long-term outcomes.

CONDITIONS

Brief Title

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

Who Can Participate

Age: 0 - 1Month

All Genders

Eligibility Criteria

You may qualify if you...

Baby is at risk for seizures or suspected to be having seizures
All seizure causes except correctable metabolic problems like low blood sugar or calcium
Term neonates with corrected gestational age between 35 and 44 weeks and postnatal age less than 28 days
Baby weighs more than 2200 grams
Parent or guardian can understand and give written informed consent

You will not qualify if you...

Seizure burden of 8 minutes per hour or more in phases 1 and 2, or 20 minutes per hour or more in phase 3
Renal failure defined as no urine output in the first 24 hours of life
Baby is near death
Seizures caused by correctable metabolic abnormalities such as low calcium or low blood sugar

Research Team

Sonya G Wang, M.D.

Brittany Faanes, MPH

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