Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate Phenobarbital Sodium Injection for the Treatment of Neonatal Seizures

NCT03602118

Neonatal Seizure

WITHDRAWN PHASE3

Prophylactic Phenobarbital After Neonatal Seizures

NCT01089504

Neonatal Seizures

TERMINATED PHASE4

Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

NCT01284556

Epilepsy

COMPLETED PHASE3

Pediatric Epilepsy Study

NCT00050934

Epilepsy Epilepsies, Partial

COMPLETED PHASE3

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

NCT04519645

Electroencephalographic Neonatal Seizures Epilepsy

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy, Benign Neonatal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenobarbital Sodium Injection 20mg

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

Group Type ACTIVE_COMPARATOR

Phenobarbital Sodium Injection

Intervention Type DRUG

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.

Phenobarbital Sodium Injection 40mg

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

Group Type ACTIVE_COMPARATOR

Phenobarbital Sodium Injection

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phenobarbital

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

34 Weeks

Maximum Eligible Age

44 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No