Dosing of Levetiracetam (Keppra) in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01239212
First received: October 28, 2010
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Seizures
Drug: levetiracetam
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacokinetic Profile [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Vital Sign Baseline [ Time Frame: 24 hours after loading dose ] [ 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 after dose ] [ 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: 7
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: levetiracetam
    50 mg/kg single loading dose of IV levetiracetam
  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239212

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, Assistant Professor, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01239212     History of Changes
Other Study ID Numbers: 101335
Study First Received: October 28, 2010
Results First Received: February 26, 2014
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
seizures
neonate
levetiracetam
Epilepsy
central nervous system diseases
anticonvulsants

Additional relevant MeSH terms:
Seizures
Epilepsy
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 September 18, 2014