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: February 14, 2017

Last verified: February 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

February 14, 2017

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: No masking
Primary Purpose: Treatment

Condition ^ICMJE

Epilepsy, Partial

Intervention ^ICMJE

Drug: Levetiracetam (Keppra)

Study Arms

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).

Sex/Gender

Sexes Eligible for Study:

All

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

U.S. FDA-regulated Product

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

PRS Account

UCB Pharma

Verification Date

February 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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