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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00545012
First received: October 15, 2007
Last updated: September 16, 2013
Last verified: September 2009

October 15, 2007
September 16, 2013
May 2000
May 2003   (final data collection date for primary outcome measure)
Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
Same as current
Complete list of historical versions of study NCT00545012 on ClinicalTrials.gov Archive Site
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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)
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.
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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Absence Seizures
Drug: Levetiracetam
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
May 2003
May 2003   (final data collection date for primary outcome measure)

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
Both
4 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00545012
N164
No
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UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP