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...
Date First Received: September 6, 2005
Last Updated: March 7, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 3 | Start Date: February 1998
Overall Status: Completed
Estimated Enrollment: 238
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”
Condition Keyword(s):
Intervention(s):
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: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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 Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Françoise Tonner, MD Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
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
Clinical Trials Authorship and Review
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