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Trial record 1 of 1 for:    NCT00545012
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A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545012
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Absence Seizures Drug: Levetiracetam Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
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)
Study Start Date : May 2000
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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

Eligibility Criteria
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Information from the National Library of Medicine

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545012


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00545012    
Other Study ID Numbers: N164
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Levetiracetam
Keppra
Additional relevant MeSH terms:
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Seizures
Epilepsy, Absence
Neurologic Manifestations
Nervous System Diseases
Epilepsy, Generalized
Epilepsy
 Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes
Levetiracetam
Anticonvulsants
Nootropic Agents