Dosing of Levetiracetam (Keppra) in Neonates

Completed · Phase 1/Phase 2

Conditions studied: Seizures

In brief

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.

Key facts

Study ID

NCT01239212

Run by

Children's Hospital Medical Center, Cincinnati

People needed

7

Starts

2010-09-01

Expected to finish

2011-07-01

Last updated by the study team

2021-09-05

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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