Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.

Inclusion Criteria:

• Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)
• Parental informed consent (in-person or remote consent)
• Undergoing continuous video electroencephalogram (cvEEG) monitoring
• Has evidence of electrographic seizure burden of at least 30 seconds/h

Exclusion Criteria:

• Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation > 24 hours before enrollment)
• Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization
• Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder
• Death appears to be imminent as assessed by the NICU attending physician
• Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.