Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures (Keppra)
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|ClinicalTrials.gov Identifier: NCT00884052|
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Seizures Disorder of Fetus or Newborn||Drug: Low dose levetiracetam Drug: High dose levetiracetam||Phase 1 Phase 2|
In adults, drug clearance is less than half of the glomerular filtration rate and the drug half-life is 6-8 hours. Renal function in infants at birth is characterized by immature glomerular filtration and is only 20% that of older children. The specific esterase responsible for levetiracetam hydrolysis has not been identified and its expression in newborn infants is unknown. Depending on its activity, the expected infant total levetiracetam clearance will likely be between 15-45% of older populations. However, due to immaturity in levetiracetam clearance in infants, accumulation with multiple dosing is possible. Therefore the maintenance dose is reduced compared to older children according to the anticipated impaired clearance.
These anticipated differences in levetiracetam clearance and volume of distribution, will likely result in a prolonged drug half-life of 10-30 hours in infants. This prolonged elimination will require longer sampling to adequately characterize levetiracetam pharmacodynamics in this population.
The primary intent of the data analysis is to determine levetiracetam pharmacokinetics in newborn infants and predict the dosage necessary to maintain concentrations similar to those seen with effective therapy in other populations. Graphs of serum concentration vs. time will be plotted for levetiracetam for each infant. Mean serum drug concentration vs. time curves will also be constructed. Summary statistics (i.e., n, mean, standard deviation, minimum, maximum, and coefficient of variation) will be calculated for serum concentrations for each time point and each dose level.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||October 2011|
Experimental: levetiracetam dose escalation
6 Babies in Phase 1-Received Dose 1: 20 mg/kg; 5 mg/kg daily 12 Babies in Phase 2-Received Dose 2: 40 mg/kg; 10 mg/kg/day
Drug: Low dose levetiracetam
20 mg/kg loading dose; 5 mg/kg daily for 7 days.
Other Name: Keppra
Drug: High dose levetiracetam
40 mg/kg IV load; 10 mg/kg/day maintenance
Other Name: Keppra
- Drug Clearance [ Time Frame: Day 1 and Day 7 ]
- Drug Half Life [ Time Frame: Day 1 and Day 7 ]
- Levetiracetam Treated Number of Participants With Serious Adverse Events [ Time Frame: 7 Days ]
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): NCT00884052
|United States, California|
|University of California, San Diego Medical Center / Neonatal Intensive Care Unit (NICU)|
|San Diego, California, United States, 92103|
|Principal Investigator:||Richard Haas, MD||University of Calfornia, San Diego|