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

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)

NCT00545012•UCB Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

4 - 17 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

May 1, 2000

Primary Completion Date

May 1, 2003

Completion Date

May 1, 2003

Last Updated

September 17, 2013

Enrollment

ACTUAL participants

Conditions

Absence Seizures

Interventions

Levetiracetam

DRUG