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

RecruitingPhase 2Ages any - 1 MonthAllUniversity of California, San Diego
NCT05610085 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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.
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What it tests

  • Levetiracetam Injection
  • Phenobarbital Sodium Injection
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Where

6 sites
University of California, San Diego
San Diego, United States
University of Minnesota
Minneapolis, United States
Auckland City Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
Health New Zealand, Te Whatu Ora - Waikato Hospital
Hamilton, New Zealand
Capital and Coast District Health Board, Te Whatu Ora, Health New Zealand
Wellington, New Zealand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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