We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dosing of Levetiracetam (Keppra) in Neonates

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239212
First Posted: November 11, 2010
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati
  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
Intervention Model: Single Group Assignment
Masking: None (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 Stephanie Merhar, MD, 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) ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 28, 2010
First Posted: November 11, 2010
Results First Submitted: February 26, 2014
Results First Posted: September 8, 2014
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Stephanie Merhar, MD, 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
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs