At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 enrolled
Drug / intervention
Lacosamidedrug
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.
A Multicenter, Open-Label Study to Investigate the Safety and Tolerability of Intravenous Lacosamide in Children (>= 1 Month to < 17 Years of Age) With Epilepsy
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 103 participants across 23 sites in 5 countries.
Detailed Summary
EP0060 is a multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) Lacosamide (LCM) in pediatric subjects \>= 1 month to \< 17 years of age with epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesHungary, Italy, Poland, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2017
Primary CompletionJun 2019
TodayJul 2026
First PostedMar 17, 2016
Enrollment StartMay 30, 2017
Primary CompletionJun 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.3 years ago
Interventions
Lacosamidedrug
Pharmaceutical form: solution for infusion Concentration: 10 mg/ml Route of Administration: intravenous