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

• ClinicalTrials.gov Identifier: NCT00150709
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: February 15, 2017
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Tracking Information

• First Submitted Date: September 6, 2005
• First Posted Date: September 8, 2005
• Last Update Posted Date: February 15, 2017
• Study Start Date: February 1998
• Actual Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: September 6, 2005): To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy, Partial
• Intervention: Drug: Levetiracetam (Keppra)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 6, 2005): 238
• Original Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00150709
• Other Study ID Numbers: 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: UCB Pharma
• Collaborators: Not Provided

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

• PRS Account: UCB Pharma
• Verification Date: February 2017