Clinical Trials Logo
  1. Home
  2. Seizures
  3. NCT00884052

Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures — Keppra  

Seizures Clinical Trial

Official title:
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures

Clinical Trial Summary

The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00884052
Study type Interventional
Source University of California, San Diego
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 2007
Completion date October 2011
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02850913 - Doxycycline for the Treatment of Nodding Syndrome Phase 2
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Not yet recruiting NCT06045676 - Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02897856 - Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures Phase 4
Completed NCT01239212 - Dosing of Levetiracetam (Keppra) in Neonates Phase 1/Phase 2
Completed NCT01236001 - Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older N/A
Completed NCT01703468 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions Phase 1
Completed NCT01702623 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions Phase 1
Recruiting NCT02216500 - Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy N/A
Completed NCT00236717 - A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT06451289 - Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
Recruiting NCT02552511 - Epidemiology Study on Neonatal Seizure
Recruiting NCT05339126 - RNS System LGS Feasibility Study Phase 2
Active, not recruiting NCT04595786 - The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection N/A
Recruiting NCT04770337 - Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy N/A