At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 97 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.
A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures
In Brief
A Phase 3 clinical trial evaluating lacosamide for Partial Epilepsies and Partial Onset Seizures. Completed, enrolled 97 participants across 7 sites.
Detailed Summary
The purpose of this study is to allow eligible subjects from the parent study, SP925 \[NCT00655551\] to continue lacosamide and to obtain additional long-term safety data
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsies, Partial Onset Seizures
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionJun 2010
TodayJul 2026
First PostedApr 10, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.2 years ago
Interventions
lacosamidedrug
Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).