At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 376 enrolled
Drug / intervention
Lacosamidedrug
Likely dose
Lacosamide 50 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.
An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures
In Brief
A Phase 3 clinical trial evaluating Lacosamide for Epilepsy. Completed, enrolled 376 participants across 54 sites in 13 countries.
Detailed Summary
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesAustralia, Croatia, Czechia, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedAug 2007
Primary CompletionAug 2010
TodayJul 2026
First PostedAug 14, 2007
Enrollment StartDec 1, 2004
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 18.9 years ago
Interventions
Lacosamidedrug
50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial