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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544050

N01052

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)