Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic Clonic Seizures

Inclusion Criteria:

-Subject must have completed or be an eligible Baseline failure from the parent study
(SP0982). Note: Other subjects screened for SP0982 may be considered for roll-over to
EP0012 if the investigator considers that the subject could benefit from treatment with
open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB
Study Physician or representative.

Exclusion Criteria:

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

- Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious
adverse event (SAE)

- Subject has an active suicidal ideation as indicated by a positive response ("Yes") to
either Question 4 or Question 5 of the "Since Last Visit" version of the
Columbia-Suicide Severity Rating Scale (C-SSRS)

- 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%).

For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin,
a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be
understood and recorded in the Case Report form (CRF).

If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening,
repeat the tests, if possible, prior to dosing to ensure there is no further ongoing
clinically relevant increase. In case of a clinically relevant increase, inclusion of the
subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP
up to 25% above the exclusion limit may be repeated once for confirmation. This includes
re-screening.