Text Size

A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00105040
First received: March 3, 2005
Last updated: February 22, 2010
Last verified: February 2010
History of Changes

March 3, 2005
February 22, 2010
September 2004
March 2007   (final data collection date for primary outcome measure)
Characterize potential cognitive and neuropsychological effects of levetiracetam as adjunctive treatment in children 4-16 years old with refractory partial onset seizures compared to placebo attention/memory scale (Leiter-R) a
Potential cognitive and neuropsychological effects of levetiracetam as adjunctive treatment in children with refractory, partial onset seizures
Complete list of historical versions of study NCT00105040 on ClinicalTrials.gov Archive Site
Scores on memory/learning battery (WRAML-2), behavioral scale (CBCL), and quality of life scale (CHQ) after 12 weeks of double blind treatment
Same as current
 
 
 
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years Old, Inclusive, With Refractory Partial Onset Seizures

A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.
 
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Epilepsy, Partial
Drug: Levetiracetam
 
Levisohn PM, Mintz M, Hunter SJ, Yang H, Jones J; N01103 Levetiracetam Study Group. Neurocognitive effects of adjunctive levetiracetam in children with partial-onset seizures: a randomized, double-blind, placebo-controlled, noninferiority trial. Epilepsia. 2009 Nov;50(11):2377-89. Epub 2009 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric subjects (4 - 16 years old) diagnosed with refractory partial onset seizures for a minimum of six months prior to Visit 1 experiencing at least two partial onset seizures during the four weeks prior to Visit 1 will be enrolled.
  • Subjects should be on a stable regimen of one or a maximum of two other AEDs for at least 2 weeks prior to Visit 1.
  • Subject must have an Intelligence Quotient (IQ) as assessed during Visit 1 of at least 70.
  • Subject and parent/guardian should be fluent in English.

Exclusion Criteria:

  • Subject must not have had previous treatment with levetiracetam unless, in the opinion of the investigator, the subject's previous treatment was inadequate in dose or duration to provide an accurate assessment of the therapy, or the effect of levetiracetam was confounded by concomitant medication.
  • Subject is receiving benzodiazepines on a routine or chronic basic and is unable to discontinue use four weeks prior to Visit 1.
  • Subject has seizures too close together to accurately count.
  • Subject has a current psychiatric disorder other than mild to moderate attention deficit, behavior, or learning disorders.
Both
4 Years to 16 Years
 
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   South Africa
 
NCT00105040
N01103
 
 
UCB, Inc.
 
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
February 2010

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