NCT01964560

A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide	Pharmaceutical form: oral solution Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day) Route of administration: oral use
DRUG	Lacosamide	Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use

Timeline

• Start date: 2014-08-13
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2013-10-17
• Last updated: 2022-10-25
• Results posted: 2022-10-25

Locations

141 sites across 35 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Moldova, Montenegro, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Korea, Taiwan, Thailand, Ukraine, United Kingdom