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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: May 2003

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary Measures

• PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.

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

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Françoise Tonner, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on October 10, 2008

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