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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Levetiracetam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: UCB Pharma

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.

Clinical Details

Official 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

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

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

Eligibility

Minimum age: 1 Month. Maximum age: 4 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Clinical Study Summary on UCB.com

Related 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.

Starting date: September 2002
Last updated: November 14, 2013

Page last updated: August 23, 2015

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