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

UCB Pharma4 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Absence Seizures

Interventions

LevetiracetamDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.