CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 255 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 10 mgfrom 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/NCT02477839
NCT02477839Phase 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 >=1 Month to <4 Years of Age With Partial-Onset Seizures

UCB BIOSCIENCES, Inc.·interventional·Posted Jun 23, 2015·Updated Jul 1, 2021

In Brief

A Phase 3 clinical trial evaluating Lacosamide and Placebo for Epilepsy With Partial-onset Seizures. Completed, enrolled 255 participants across 88 sites in 26 countries.

Detailed Summary

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy With Partial-onset Seizures
CountriesArgentina, Brazil, Bulgaria, China, Croatia, Czechia, France, Georgia, Greece, Hungary, Israel, Italy, Mexico, Moldova, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Thailand, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartJun 5, 2015
Primary CompletionMay 28, 2020
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 11.0 years ago

Interventions

Lacosamidedrug

Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral

Placeboother

Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral