Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Phase 2
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00544050
- Lead Sponsor
- UCB Pharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.
- Secondary Outcome Measures
Name Time Method