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Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

NCT04320940 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-10-26

Study results available
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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.

Conditions

  • Epilepsy, Benign Neonatal

Interventions

DRUG

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.

Sponsors & Collaborators

  • NEMA Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Pergolizzi Jr., MD, MD · NEMA Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
34 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2023-02-01
Completion
2023-02-01
FDA Drug
Yes

Countries

  • United States
  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320940 on ClinicalTrials.gov