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Dosing of Levetiracetam (Keppra) in Neonates

NCT01239212 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-09-05

Study results available
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Summary

The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Conditions

Interventions

DRUG

levetiracetam

50 mg/kg single loading dose of IV levetiracetam

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Stephanie Merhar, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01239212 on ClinicalTrials.gov