This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained...
Date First Received: October 15, 2007
Last Updated: March 7, 2008
Verified by: UCB, March 2008
Clinical Trial Phase: Phase 2 | Start Date: May 2000
Overall Status: Completed
Estimated Enrollment: 4
Brief Summary
Official Title: “A 30-Month Safety and Efficacy Follow-up Study With Levetiracetam at Individualized Optimal Dose in Children (4-17 Years Old at Inclusion) Suffering From Typical Absences in Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE)”
Condition Keyword(s):
Intervention(s):
This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: May 2003
Intervention(s) in this Clinical Trial
- Drug: Levetiracetam
Outcome Measures for this Clinical Trial
Primary Measures
- Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male/female 4-17 years old having participated in study N162 or in study N163
- suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
- expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration
Exclusion Criteria:
- allergy/intolerance to pyrrolidine derivatives and/or excipients
- use of > 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 4 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
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 September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00545012
Study ID Number: N164
ClinicalTrials.gov Identifier: NCT00545012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Clinical Trials Authorship and Review
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