At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 540 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 540 participants across 141 sites in 35 countries.
Detailed Summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, 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, United States
CollaboratorsUCB Biopharma SRL
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 2013
Enrollment StartAug 2014
Primary CompletionApr 2022
TodayJul 2026
First PostedOct 17, 2013
Enrollment StartAug 13, 2014
Primary CompletionApr 13, 2022
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 12.7 years ago
Interventions
Lacosamidedrug
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
Lacosamidedrug
Pharmaceutical form: tablet Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day) Route of administration: oral use