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

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

Condition Intervention Phase
Absence Seizures Drug: Levetiracetam Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

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

Enrollment: 4
Study Start Date: May 2000
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00545012

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information: Identifier: NCT00545012     History of Changes
Other Study ID Numbers: N164
Study First Received: October 15, 2007
Last Updated: September 16, 2013

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Epilepsy, Generalized
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on September 21, 2017