Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Levetiracetam (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: UCB Pharma
Summary
The primary purpose of this study was to document the pharmacokinetic parameters of both
levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam
in epileptic pediatric subjects, aged 1 month to less than 4 years.
Clinical Details
Official title: An Open-Label, Single Dose, Pharmacokinetic Study of 20 mg/kg of Levetiracetam Oral Solution in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
Eligibility
Minimum age: 1 Month.
Maximum age: 4 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- male or female between 1 month and less than 4 years
- diagnosis of any type of epilepsy
- at least 5 kg body weight
- using no more than two antieplieptic drugs
Exclusion Criteria:
- a treatable seizure etiology
- epilepsy secondary to a progressive cerebral disease or any other progressively
neurodegenerative disease
- history of status epilepticus during the 2 weeks prior to the Selection Visit
- history of or the presence of pseudoseizures
- epilepsy surgery within one year prior to the Selection Visit
- on a ketogenic diet
- taking felbamate at the Selection Visit
Locations and Contacts
Additional Information
Clinical Study Summary on UCB.com
Related publications: Glauser TA, Mitchell WG, Weinstock A, Bebin M, Chen D, Coupez R, Stockis A, Lu ZS. Pharmacokinetics of levetiracetam in infants and young children with epilepsy. Epilepsia. 2007 Jun;48(6):1117-22. Epub 2007 Apr 18.
Starting date: September 2002
Last updated: November 14, 2013
|