A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on
 Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or
 greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs.
 Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to
 enter the open-label extension study after completion.
Inclusion Criteria:

 -  Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease
 onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE)
 experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are
 classifiable according to the International League Against Epilepsy (ILAE)
 Classification of Epileptic Seizures (ILAE, 1981)

 -  Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical
 Baseline plus 4-week Prospective Baseline)

 -  If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been
 performed, there must be no evidence of any progressive abnormality or any lesion
 likely to be associated with partial-onset seizures

 -  Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine
 marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine
 marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior
 to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)

 -  Subjects are required to have had an electroencephalogram (EEG) report consistent with
 idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a
 normal EEG background) confirmed by a Central Reviewer

 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 electronic case report form (eCRF).

 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.