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Phase 2Recruiting

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures (NEOLEV3)

A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures

Sponsor
University of California, San Diego (Academic or other)
Enrollment
133 planned
Conditions
Neonatal Seizure; Neonatal Encephalopathy; Hypoxic-Ischemic Encephalopathy; Seizure Newborn
Interventions
Levetiracetam Injection; Phenobarbital Sodium Injection
Ages
children
Registry
NCT05610085

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • The primary endpoint is the maximum safe and tolerated dose of Levetiracetam

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered