Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

Summary

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.

Timeline

Start

2021-03-12

Primary completion

2023-02-01

Completion

2023-02-01

Drugs

Indications