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

UCB Pharma13 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

LevetiracetamDRUG

Eligibility

Sex: ALLMin age: 1 MonthMax age: 4 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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