CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 404 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 4 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.

Search/NCT01921205
NCT01921205Phase 3Completed
CompareCT.gov

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

UCB Pharma·interventional·Posted Aug 13, 2013·Updated Jul 18, 2018

In Brief

A Phase 3 clinical trial evaluating Lacosamide and Placebo for Epilepsy. Completed, enrolled 404 participants across 118 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 13, 2013
Enrollment StartAug 29, 2013
Primary CompletionJan 24, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.9 years ago

Interventions

Lacosamidedrug

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)

Placeboother

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)