At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 366 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 2 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.
An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy
In Brief
A Phase 2 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 366 participants across 69 sites in 11 countries.
Detailed Summary
SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, China, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartDec 2009
Primary CompletionMay 2021
TodayJul 2026
First PostedJul 14, 2009
Enrollment StartDec 9, 2009
Primary CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 17.0 years ago
Interventions
Lacosamidedrug
Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)
Lacosamidedrug
Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid). The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.