Back to resultsDosing of Levetiracetam (Keppra) in Neonates
Primary Purpose
Seizures
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring seizures, neonate, levetiracetam, Epilepsy, central nervous system diseases, anticonvulsants
Eligibility 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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01239212
First Posted
October 28, 2010
Last Updated
August 11, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01239212
Brief Title
Dosing of Levetiracetam (Keppra) in Neonates
Official Title
Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
seizures, neonate, levetiracetam, Epilepsy, central nervous system diseases, anticonvulsants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Description
50 mg/kg single loading dose of IV levetiracetam
Primary Outcome Measure Information:
Title
Pharmacokinetic Profile
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Merhar, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dosing of Levetiracetam (Keppra) in Neonates
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