Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

NEMA Research

Status and phase: Terminated; Phase 3

Conditions: Epilepsy, Benign Neonatal

Treatments: Drug: Phenobarbital Sodium Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04320940

MI-5780

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 34 to 44 weeks old

Volunteers: No Healthy Volunteers

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
• Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups

Phenobarbital Sodium Injection 20mg

Active Comparator group

Description:

Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 20 mg/kg (first/initial dose) followed by 20 mg/kg (if required).

Treatment:

Drug: Phenobarbital Sodium Injection

Phenobarbital Sodium Injection 40mg

Active Comparator group

Description:

Following confirmation of seizure criteria and randomization, subjects will receive Phenobarbital 40 mg/kg (first/initial dose) followed by 10 mg/kg (if required).

Treatment:

Drug: Phenobarbital Sodium Injection