An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)

Subject \>= 6 years of age has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Subjects who have participated in SP847 or other LCM pediatric clinical studies in epilepsy are not permitted to enroll in the study if any of the following criteria are met:

Subject meets either of the following:

1. Withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a dose reduction or status epilepticus). For subjects entering from EP0060, if the subject (or legal guardian) withdraws consent solely due to route of LCM administration (iv) or if the subject requires more than 10 iv LCM infusions, the subject may be allowed to participant in SP848 after discussion with and agreement from the Medical Monitor

2. Ongoing serious Adverse Event (SAE)

Subjects who enroll directly into SP848 without previous participation in a LCM clinical study are not permitted to enroll in the study if any of the following criteria are met:

Subject has ever received LCM

Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.

Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion

Subject has a known hypersensitivity to any component of the investigational medicinal product

Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of the study

Subject has a creatinine clearance less than 30mL/min

Subject has a clinically relevant ECG abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450ms)

Subject has hemodynamically significant heart disease (eg, heart failure)

Subject has an arrhythmic heart condition requiring medical therapy

Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias

Subject has nonepileptic events, including psychogenic seizures, that could be confused with seizures. If both epileptic and nonepileptic events are present, epileptic events must be distinguished from nonepileptic phenomena

Subject has a history of primary generalized epilepsy

Subject is taking monoamine oxidase inhibitors-A (MAOI-A) or narcotic analgesics.

Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome

Subject has a known sodium channelopathy, such as Brugada syndrome

Subject has \>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%)

Subjects who were directly enrolled in EP0060 for iv LCM replacement therapy or to initiate LCM treatment are not permitted to enroll in the study if any of the following criteria are met:

\- Subjects have previously participated in a long-term, open-label LCM study

What this study is about