Clinical trial NCT04320940: Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Official title: A Randomized, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy, Benign Neonatal
Keywords: Neonatal Seizures
Phenobarbital
Anticonvulsants
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 4
Sex: ALL
Minimum age (years): 34
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
timeFrame: 24 hours
Secondary outcomes:
measure: Neonates Who do Not Require Additional Seizure Treatment After the First Dose of Phenobarbital.
timeFrame: 2 hours
measure: Neonates Who do Not Require Additional Seizure Treatment After the Second Dose of Phenobarbital.
timeFrame: 24 hours
measure: Seizure Burden Over 48 Hours Following Initial Administration of the Phenobarbital Injection.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Cildren's Hospital
state: Arkansas
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Tampa
country: United States
facility: Jamie Flores-Torres
state: Florida
city: Pittsburgh
country: United States
facility: Matthew Butoryak
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Huntington
country: United States
facility: Marshall Health
state: West Virginia
city: Irbid'
country: Jordan
facility: Jordan University of Science and Technology (King Abdullah University Hospital, KAUH)
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph Pergolizzi Jr., MD, MD
role: PRINCIPAL_INVESTIGATOR
References: