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Pharmacokinetics of Levetiracetam (Keppra) in Neonates

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01261416
First received: December 15, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Seizures
Epilepsy
 Drug: levetiracetam

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 24 hours after dose ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Change in vital sign baseline [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.

  • Number of participants with adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.


Enrollment: 18
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infants with seizures 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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261416

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Stephanie Merhar, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Stephanie Merhar MD, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT01261416     History of Changes
Other Study ID Numbers: 101335-2
Study First Received: December 15, 2010
Last Updated: December 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
seizures
epilepsy
neonatal
levetiracetam

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013