Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Partial Epilepsies, Partial Onset Seizures

Intervention / Treatment
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* Drug: lacosamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures Exclusion Criteria: Receiving any study drug or experimental device other than lacosamide Meets withdrawal criteria for parent study SP925 [NCT00655551] Experiencing ongoing serious adverse event

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) | Drug: lacosamide<br>* 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).<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | 2 years | 
| Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years) | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, seizures, antiepileptic, Lacosamide, Vimpat, safety, adjunctive