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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

September 6, 2005
September 16, 2013
February 1998
January 2006   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00150709 on ClinicalTrials.gov Archive Site
To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
Same as current
Not Provided
Not Provided
 
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy, Partial
Drug: Levetiracetam (Keppra)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
January 2006
January 2006   (final data collection date for primary outcome measure)

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).
Both
up to 16 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00150709
N157
Not Provided
Not Provided
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

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