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

Tracking Information
First Submitted Date ICMJE	September 6, 2005
First Posted Date ICMJE	September 8, 2005
Last Update Posted Date	February 15, 2017
Study Start Date ICMJE	February 1998
Actual Primary Completion Date	January 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 6, 2005)	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; (submitted: September 6, 2005)	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: None (Open Label); 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; (submitted: September 6, 2005)	238
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2006
Actual 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
IPD Sharing Statement	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