Conditions: Partial Epilepsies Partial Onset Seizures
Keywords: Epilepsy seizures antiepileptic Lacosamide Vimpat safety adjunctive
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 97
Healthy volunteers: no

Brief 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

Detailed description:
A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study \[NCT00655551\] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).

Arms:
arm 1: Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

Interventions: intervention 1: lacosamide
Intervention descriptions: intervention 1: 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).

Protocol document: