A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures

Phase 2

Completed

• Conditions: Absence Seizures

• Registration Number: NCT00545012
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Status Verified: 2009-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam