Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

Stopped early · Phase 3

Conditions studied: Epilepsy, Benign Neonatal

In brief

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.

Key facts

Study ID

NCT04320940

Run by

NEMA Research, Inc.

People needed

4

Starts

2021-03-12

Expected to finish

2023-02-01

Last updated by the study team

2023-10-26

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arkansas Cildren's Hospital — Little Rock, Arkansas, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• South Miami Hospital — Miami, Florida, United States
• Jamie Flores-Torres — Tampa, Florida, United States
• Matthew Butoryak — Pittsburgh, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Marshall Health — Huntington, West Virginia, United States
• Jordan University of Science and Technology (King Abdullah University Hospital, KAUH) — Irbid, Jordan

Full record on ClinicalTrials.gov

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