A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2006
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam (Keppra)
Outcome Measures for this Clinical Trial
Primary 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 Measures
- To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
Criteria for Participation in this Clinical Trial
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).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 16 Years
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCB Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150709
Study ID Number: N157
ClinicalTrials.gov Identifier: NCT00150709
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00150709
