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Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

NCT00884052 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-03-26

Study results available
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Summary

The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.

Conditions

Interventions

DRUG

Low dose levetiracetam

20 mg/kg loading dose; 5 mg/kg daily for 7 days.

DRUG

High dose levetiracetam

40 mg/kg IV load; 10 mg/kg/day maintenance

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Richard H. Haas

    lead OTHER

Principal Investigators

  • Richard Haas, MD · University of Calfornia, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-03-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00884052 on ClinicalTrials.gov