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

Absence Seizures Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545012
• Other study ID #: N164
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2007
• Last updated: September 16, 2013
• Start date: May 2000
• Est. completion date: May 2003

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Absence Seizures
• Epilepsy, Absence
• Seizures

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

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

External Links

•   Clinical Study Summary on UCB.com