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

UCB

Status and phase: Completed; Phase 2

Conditions: Absence Seizures

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545012

N164

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)