Phase 2 N=7 Treatment

Dosing of Levetiracetam (Keppra) in Neonates

Seizures

Bottom Line

View on ClinicalTrials.gov: NCT01239212 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Pharmacokinetic Profile — 0.51 ml/min/kg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: levetiracetam (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic Profile	0.51	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01239212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.