drugset / Trial / NCT00105040
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2004-09
- Primary completion
- 2007-03
- Completion
- 2007-03
Publications
- Results 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. doi: 10.1111/j.1528-1167.2009.02197.x. Epub 2009 Aug 21.
- Results de la Loge C, Hunter SJ, Schiemann J, Yang H. Assessment of behavioral and emotional functioning using standardized instruments in children and adolescents with partial-onset seizures treated with adjunctive levetiracetam in a randomized, placebo-controlled trial. Epilepsy Behav. 2010 Jul;18(3):291-8. doi: 10.1016/j.yebeh.2010.04.017. Epub 2010 May 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 20 mg/kg | Oral |
| Subject | Levetiracetam | Other / unclassified | 60 mg/kg | Oral |