Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Epilepsy Clinical Trial

Official title:

Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261416
• Other study ID #: 101335-2
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: December 15, 2010
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: December 2010
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• 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 NICU at Cincinnati Children's Hospital or Good Samaritan 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Drug:
• levetiracetam
Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.

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	Blood specimens for quantitation of levetiracetam and its metabolite L057 will be obtained from an indwelling vascular catheter not used for study drug infusion or by heel stick in three different sampling schedules: Group 1 (n=6): at times 2-15 minutes after the end of infusion, 1-2 hours, and 12 hours post start of infusion Group 2 (n=6): at times 2-15 minutes after the end of infusion, 2-4 hours, and 18 hours post start of infusion Group 3 (n=6): at times 2-15 minutes after the end of infusion, 4-8 hours, and 20-24 hours post start of infusion	24 hours after dose	No
Secondary	Change in vital sign baseline	Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.	24 hours	Yes
Secondary	Number of participants with adverse events	Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.	24 hours	Yes