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

This study has been completed.

Sponsor:

Information provided by:

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT00544050

First received: October 15, 2007

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2007

Last Updated Date

September 14, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00544050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Levetiracetam

Study Arm (s)

Not Provided

Publications *

Glauser TA, Mitchell WG, Weinstock A, Bebin M, Chen D, Coupez R, Stockis A, Lu ZS. Pharmacokinetics of levetiracetam in infants and young children with epilepsy. Epilepsia. 2007 Jun;48(6):1117-22. Epub 2007 Apr 18.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2003

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 4 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00544050

Other Study ID Numbers ^ICMJE

N01052

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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