NCT00175890

A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 1 Month – 4 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Epilepsy, Partial

Interventions

Type	Name	Description
DRUG	Levetiracetam	Dosing was stratified by age. A dose of 20 mg/kg/day titrating to 40 mg/kg/day for children one month to less than six months old and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for children 6 month to less than 4 years old, was used in this study. The total daily dose was administered b.i.d.
OTHER	Placebo	Placebo solution, which is indistinguishable from the Levetiracetam oral solution.

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-15
• Last updated: 2020-10-01

Locations

86 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Mexico, Poland, Romania, Russia, United Kingdom