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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545012

Enrollment

Registered

2007-10-16

Start date

2000-05-31

Completion date

2003-05-31

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absence Seizures

Keywords

Levetiracetam, Keppra

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.

Interventions

DRUGLevetiracetam

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 17 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026