clinical trial · NCT04320940
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
NEMA Research, Inc.·phase3·terminated·n = 4
Epilepsy, Benign NeonatalPhenobarbital Sodium Injection
brief 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.
started
Mar 12, 2021
primary completion
Feb 1, 2023
completion
Feb 1, 2023
last updated
Oct 26, 2023
official title
A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol