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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00105040
First received: March 3, 2005
Last updated: February 27, 2015
Last verified: February 2015

March 3, 2005
February 27, 2015
September 2004
March 2007   (final data collection date for primary outcome measure)
Change from Baseline in the Leiter International Performance Scale-Revised (Leiter-R) Attention and Memory (AM) Battery's Memory Screen Composite Score from Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit) [ Time Frame: Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit) ] [ Designated as safety issue: No ]
The Leiter-R includes two groupings of sub-tests: (1) the Visualization and Reasoning (VR) Battery with 10 sub-tests of nonverbal intellectual ability related to visualization, reasoning, and spatial ability; and (2) the Attention and Memory (AM) Battery with 10 sub-tests of nonverbal attention and memory function. The Examiner Rating Scale has 49 items that describe the child's activity level, attention, impulse control, and other emotional characteristics that may interact with test performance. The focus of the items is on actions, verbalizations, moods and other behaviors of the child. The examiner rates the child using the following scale: 0 = rarely or never; 1 = sometimes; 2 = often; 3 = usually or always.
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
  • Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) General Memory from Baseline to Week 12 or Early Discontinuation Visit (EDV) [ Time Frame: Baseline to Week 12 or EDV ] [ Designated as safety issue: No ]
    The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
  • Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Visual Memory Index from Baseline to Week 12 or Early Discontinuation Visit (EDV) [ Time Frame: Baseline to Week 12 or EDV ] [ Designated as safety issue: No ]
    The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
  • Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Verbal Memory Index from Baseline to Week 12 or Early Discontinuation Visit (EDV) [ Time Frame: Baseline to Week 12 or EDV ] [ Designated as safety issue: No ]
    The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
  • Change from Baseline in Wide Range Assessment of Memory and Learning-Second Edition (WRAML-2) Attention/Concentration Index from Baseline to Week 12 or Early Discontinuation Visit (EDV) [ Time Frame: Baseline to Week 12 or EDV ] [ Designated as safety issue: No ]
    The WRAML-2 is comprised of 2 Verbal, 2 Visual, and 2 Attention-Concentration sub-tests, yielding a Verbal Memory Index, a Visual Memory Index and an Attention-Concentration Index. Together these sub-tests yield a General Memory Index. Scaled and standard scores allow performance comparisons based on age and 4 delayed recall sub-tests include guidelines for determining the level of recall. A composite General Memory Index score will be computed.
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Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Epilepsy, Partial
  • Drug: Levetiracetam
    Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
    Other Name: Keppra
  • Other: Placebo (PB)
    Oral tablets and oral solution
  • Experimental: Levetiracetam (LEV)
    Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
    Intervention: Drug: Levetiracetam
  • Placebo Comparator: Matching Placebo (PBO)
    Oral tablets and oral solution.
    Intervention: Other: Placebo (PB)

*   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 antiepileptic drugs (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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   South Africa
 
NCT00105040
N01103, 2014-004396-23
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center UCB Pharma
UCB Pharma
February 2015

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