RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: University of California, San Diego • ClinicalTrials.gov ID: NCT05610085

Registry updated: 2026-10-15

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Description

The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 20 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD

Interventions

Levetiracetam Injection (Drug)
Neonates will be treated with intravenous levetiracetam 60mg/kg for first line management of seizures, and if seizures persist will be randomized to receive higher dose Levetiracetam or standard of care phenobarbital
Phenobarbital Sodium Injection (Drug)
Standard of care for neonatal seizures

Eligibility criteria

Inclusion Criteria: * at risk for seizures or suspected to be having seizures; * all seizure aetiologies except correctable metabolic abnormalities such as hypoglycaemia and hypocalcaemia; * Term neonates (corrected gestational age between 35 and 44 weeks, postnatal age less than 28 days); * weight \> 2200g. * Parental ability to comprehend and provide written informed consent Exclusion Criteria: * Cumulative seizure burden of 8 minutes/ hour or more in phases 1 and 2, Cumulative seizure burden of 20 minutes/hour or more in phase 3; * Renal failure defined as anuria in the first 24 hours of life; * Subjects in whom death seems imminent; * Seizures caused by correctable metabolic abnormality, such as hypocalcaemia, hypoglycaemia.

Conditions

Neonatal Seizure Neonatal Encephalopathy Hypoxic-Ischemic Encephalopathy Seizure Newborn

Locations

University of California, San Diego — San Diego, California, United States
University of Minnesota — Minneapolis, Minnesota, United States
Auckland City Hospital — Auckland, Auckland, New Zealand
Middlemore Hospital — Auckland, Auckland, New Zealand
Health New Zealand, Te Whatu Ora - Waikato Hospital — Hamilton, Waikato Region, New Zealand
Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand — Wellington, Wellington Region, New Zealand

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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