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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544050
• Other study ID #: N01052
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2007
• Last updated: November 14, 2013
• Start date: September 2002
• Est. completion date: May 2003

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of both levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg levetiracetam.

External Links

•   Clinical Study Summary on UCB.com