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

November 14, 2013 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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