A Phase 2 interventional study of Levetiracetam and Placebo (PB) in Epilepsy, Partial, sponsored by UCB Pharma. Completed at 45 sites in 3 countries. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-03-02.
Sponsored by UCB Pharma · Phase 2, Interventional, and Treatment
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 87 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Drug: Levetiracetam
Oral tablets and oral solution.
Other: Placebo (PB)
Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing.
Also known as: Keppra
Oral tablets and oral solution
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)
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.
Time frame: Baseline (Visit 2) to the end of the Evaluation Period (Week 12 or Early Discontinuation Visit)
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)
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.
Time frame: Baseline to Week 12 or EDV
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)
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.
Time frame: Baseline to Week 12 or EDV
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)
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.
Time frame: Baseline to Week 12 or EDV
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)
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.
Time frame: Baseline to Week 12 or EDV
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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