Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures

The primary objective of this study is to evaluate the long-term safety and tolerability of
LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with
epilepsy ≥1 month to ≤18 years of age who currently have uncontrolled partial onset seizures.

The secondary objective is to evaluate the efficacy during long-term exposure to LCM in
subjects epilepsy ≥1 month to ≤18 years of age.

An additional objective is to assess behavior, cognition, quality of life, and development
during long-term LCM exposure in pediatric subjects

Inclusion Criteria:

- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
written Informed Consent form (ICF) is signed and dated by the subject or legal
representative. The ICF or a specific Assent form, where required, will be signed and
dated by minors

- Subject has completed the Transition Period of SP0967 or SP0969 (NCT01921205) for the
treatment of uncontrolled partial-onset seizures in pediatric epilepsy

- Subject is expected to benefit from participation, in the opinion of the investigator

- Subject/legal representative is considered reliable and capable of adhering to the
protocol (eg, able to understand and complete diaries), visit schedule, and medication
intake according to the judgment of the investigator

- Subject is male or female aged 1 month to ≤17 years.

- Subject has a diagnosis of epilepsy with partial onset seizures.

Exclusion Criteria:

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

- Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for
SP0967 or SP0969, or is experiencing an ongoing Serious Adverse Event (SAE)

- For subjects ≥6 years of age, subject 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 Visit 1

- 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