Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NEMA Research, Inc.
• Collaborator: Hikma Pharmaceuticals USA Inc.
• Treatments: Phenobarbital

Criteria

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