Dosing of Levetiracetam (Keppra) in Neonates

Phase 1

Completed

• Conditions: Seizures

• Registration Number: NCT01239212
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2014-02-26
• Results First Submitted QC: 2014-08-27
• Results First Posted: 2014-09-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Gestational age ≥ 32 weeks
• Postnatal age ≤ 30 days
• Birth weight ≥ 2000 grams
• Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
• Clinical or electrographic seizures of any etiology
• Seizures or seizure prophylaxis requiring treatment with levetiracetam
• Parental consent obtained

Exclusion Criteria

• Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
• Infants who have previously received levetiracetam
• Parents refuse consent
• Attending physician does not wish the infant to be enrolled in the study
• Infants who are currently receiving an investigational drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Profile	5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)	3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States