A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.

SP0966 is a Phase 2, multicenter, open-label exploratory study designed to assess the safety
and preliminary efficacy of oral lacosamide as adjunctive therapy for epilepsy syndromes
associated with generalized seizures in pediatric subjects ≥1 month to <18 years of age.

Inclusion Criteria:

- A signed informed consent has been obtained from the parent/legal representative and
assent has been obtained from the subject (when possible)

- Subject and caregiver are willing and able to comply with all study requirements
including maintaining a daily seizure diary

- Subject is male or female, ≥1 month to <18 years of age

- Subject has a diagnosis of uncontrolled epilepsy with generalized seizures (Type II)
according to the International Classification of Epileptic Seizures (1981). The
underlying epilepsy syndrome should be documented. Diagnosis should have been
established by clinical history and an Electroencephalogram (EEG) with generalized
spike-wave discharges. Documentation of the EEG finding of generalized spike waves
(EEG recording or a report) is required. The EEG should have been performed no more
than 18 months prior to Visit 1 (with no change to diagnosis or seizure types during
this time)

- Subject must have experienced 2 or more events (typical generalized seizures
associated with diagnosed epilepsy syndrome) within the 6-week prospective Baseline
Period

- Subject is on a stable dosage regimen of 1 to 3 antiepileptic drugs (AEDs). The daily
dosage regimen of concomitant AED therapy must be kept constant for a period of at
least 4 weeks prior to the Baseline Period

- Vagal nerve stimulation is allowed and will not be counted as a concomitant AED. The
vagus nerve stimulation (VNS) device must be implanted for at least 6 months before
Visit 1, and the device settings must be stable for at least 4 weeks before Visit 1
and be kept stable during the Baseline Period and the Treatment Period. Use of the VNS
device magnet is allowed

- Body weight at Visit 1 is at least 4 kg for infants.

- Females of childbearing potential must have a negative pregnancy test at Visit 1

- Subjects with West Syndrome are eligible if Baseline EEG demonstrates hypsarrhythmia
despite treatment with at least 2 AEDs appropriate for the treatment of this syndrome

Exclusion Criteria:

- Subject has previously participated in this study, subject has been assigned to
Lacosamide (LCM) in a previous LCM study, or subject has ever received LCM

- Subject is currently participating or has participated within the last 2 months in any
study of an investigational drug or experimental device

- Subject has a history of convulsive status epilepticus within 1 month prior to Visit 1

- Subject has a current or previous diagnosis of pseudoseizures, conversion disorders,
or other nonepileptic ictal events that could be confused with seizures

- Subject has exclusively typical absence (Type IIA1) or atypical absence (Type IIA2)
seizures (no other generalized seizure types are reported), or has only partial-onset
seizures (Type I)

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

- Subject ≥6 years of age has a lifetime history of suicide attempt (including an actual
attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the
past 6 months as indicated by a positive response ("Yes") to either Question 4 or
Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening

- Subject has a known hypersensitivity to any components of the investigational
medicinal product (IMP)

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

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

- Subject has any history of alcohol or drug abuse within the previous 2 years

- Subject has an acute or sub-acutely progressive central nervous system disease.
Subject has epilepsy secondary to a progressing cerebral disease or any other
progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)

- Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
bilirubin levels ≥2x the upper limit of normal (ULN) or has alkaline phosphatase
levels ≥3x ULN

- Subject has impaired renal function (ie, creatinine clearance is lower than 30 mL/min)
at Visit 1

- Subject has sick sinus syndrome without a pacemaker, or second or third degree
atrioventricular (AV) block

- Subjects with second- or third-degree heart block are excluded from SP0966
(NCT01969851), without the requirement of being at rest

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

- Subject has an arrhythmic heart condition requiring medical therapy

- Subject has a known cardiac sodium channelopathy, such as Brugada syndrome

- Female subject who is pregnant or nursing, and/or a female subject of childbearing
potential who is not surgically sterile or does not practice 1 highly effective method
of contraception (according to International Conference on Harmonisation [ICH]
guidance. Female subject of childbearing potential taking enzyme inducing
antiepileptic drugs(EI AEDs) (carbamazepine, phenytoin, barbiturates, primidone,
topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly
effective method of contraception according to the World Health Organization
recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate,
intrauterine devices, combined injectables, and progestogen implants) with
administration of enzyme inducing antiepileptic drugs (EI-AEDs) or does not practice 2
combined methods of contraception (ie, combined hormonal contraception plus barrier
method with spermicidal agent), unless sexually abstinent, for the duration of the
study

- Subject has been treated with vigabatrin and experienced any vision loss. Subjects who
have received vigabatrin in the past must have documentation of an assessment for
vision loss prior to study entry or documentation of why visual field testing cannot
be performed

- Subject has been treated with felbamate and has experienced any serious toxicity
issues (defined as liver failure, aplastic anemia) with this treatment. Subjects
treated with felbamate for less than 12 months are excluded. Note: any subject who has
been treated with felbamate for at least 12 months and has not experienced serious
toxicity issues is eligible

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

- Subject is on a ketogenic or other specialized diet. If he/she was on a specialized
diet in the past, he/she must be off the diet for at least 2 months prior to the
Screening Visit (Visit 1)

- Subject has primary generalized tonic-clonic seizures with a diagnosis of idiopathic
generalized epilepsy