NCT04320940

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: NEMA Research, Inc. · Industry
• Sex: All
• Age: 34 Weeks – 44 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy, Benign Neonatal

Interventions

Type	Name	Description
DRUG	Phenobarbital Sodium Injection	The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose.

Timeline

• Start date: 2021-03-12
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2020-03-25
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

8 sites across 2 countries: United States, Jordan

Regulatory

• FDA-regulated drug study