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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00544050

Enrollment

Registered

2007-10-16

Start date

2002-09-30

Completion date

2003-05-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Levetiracetam, Keppra

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.

Interventions

DRUGLevetiracetam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 4 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026