Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

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