NCT00113815

Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).

Detailed description

This is a world wide, multicenter, randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety and efficacy of 3 target doses (5, 15, and 25 mg/kg/day) of topiramate compared with placebo as an adjunct therapy in infants with refractory partial onset seizures (POS). There are 4 phases to the study, a screening phase of 3 days, a double blind treatment phase of 20 days, a one year open label extension phase and a posttreatment (taper and withdrawal) phase. The oral liquid formulation will also be assessed during this study, as it is investigational, unlike the marketed sprinkle formulation. 5, 15, 25 mg/kg/day of topriramate sprinkle and oral liquid formulation will be administered during the four phases of the study.

Conditions

• Partial Seizure Disorder
• Epilepsy
• Seizures

Interventions

Type	Name	Description
DRUG	topiramate	15 mg/kg/day
DRUG	topiramate	5 mg/kg/day
DRUG	topiramate	25 mg/kg/day
DRUG	placebo	placebo

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-06-01
• Completion: 2007-11-01
• First posted: 2005-06-13
• Last updated: 2014-03-26

Locations

94 sites across 23 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Finland, France, Hungary, India, Israel, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine