Back to resultsA Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Primary Purpose
Epilepsy, Partial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levetiracetam (Keppra)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Partial focused on measuring Epilepsy, Pediatric , partial onset epilepsy,, Levetiracetam (Keppra®)
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).
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150709
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial
Keywords
Epilepsy, Pediatric , partial onset epilepsy,, Levetiracetam (Keppra®)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
238 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam (Keppra)
Primary Outcome Measure Information:
Title
To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
Title
Efficacy measured by weekly seizure frequency.
Secondary Outcome Measure Information:
Title
To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
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