Dosing of Levetiracetam (Keppra) in Neonates

Seizures Clinical Trial

Official title:

Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239212
• Other study ID #: 101335
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• levetiracetam
50 mg/kg single loading dose of IV levetiracetam

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Profile	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.	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)