Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2003
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Outcome Measures for this Clinical Trial
Primary Measures
- PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Month
Maximum Age for this Clinical Trial: 4 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00544050
Study ID Number: N01052
ClinicalTrials.gov Identifier: NCT00544050
Health Authority: United States: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00544050
