NCT01921205

Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.

Detailed description

The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures. The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4 years to \<17 years of age. An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years to \<17 years of age.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	Subjects \<30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day) Subjects ≥30 kg to \<50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day) Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)
OTHER	Placebo	Subjects \<30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day) Subjects ≥30 kg to \<50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day) Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

Timeline

• Start date: 2013-08-29
• Primary completion: 2017-01-24
• Completion: 2017-01-24
• First posted: 2013-08-13
• Last updated: 2018-07-18
• Results posted: 2018-03-19

Locations

118 sites across 28 countries: United States, Argentina, Australia, Belgium, Bulgaria, Colombia, Croatia, Czechia, Estonia, Georgia, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Montenegro, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, South Korea, Taiwan, Thailand, Ukraine, United Kingdom