A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

This study has been completed.

Sponsor:

Information provided by:

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00150709

First received: September 6, 2005

Last updated: September 16, 2013

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

September 16, 2013

Start Date ^ICMJE

February 1998

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
Efficacy measured by weekly seizure frequency.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00150709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Official Title ^ICMJE

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Brief Summary

The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Epilepsy, Partial

Intervention ^ICMJE

Drug: Levetiracetam (Keppra)

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

238

Completion Date

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

Exclusion Criteria:

Not be on a ketogenic diet (during the course of this study).
Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Gender

Both

Ages

up to 16 Years (Child)

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00150709

Other Study ID Numbers ^ICMJE

N157

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

UCB Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

UCB Pharma

Information Provided By

UCB Pharma

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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