A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|Official Title:||A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age. N01009|
- Responder Rate for total partial onset seizures defined as the number of subjects with a greater than or equal to 50% reduction in average daily frequency of partial onset seizures recorded on 48-hour EEG video.
- Responder rate for total seizures (all types) for completed subjects and dropouts
- Percent reduction and absolute reduction 1. average daily frequency (ADF) of partial onset seizures and 2. ADF of total seizures
|Study Start Date:||October 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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|Study Director:||UCB Clinical Trial Call Center||UCB, Inc.|