At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 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, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures
In Brief
A Phase 2 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 47 participants across 21 sites in 3 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Mexico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartNov 2009
Primary CompletionAug 2014
TodayJul 2026
First PostedJul 13, 2009
Enrollment StartNov 1, 2009
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.0 years ago
Interventions
Lacosamidedrug
Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL