Pharmacokinetic Study of Levetiracetam 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Oct 16, 2007
Registry last updated: Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed