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
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide Tablet; Lasosamide Oral Solution; Placebo Tablet; Placebo Oral Solution
Intervention description: Active Substance: Lacosamide
Pharmaceutical Form: Film-coated Tablet
Concentration: 50 mg
Route of Administration: Oral use; Active Substance: Lacosamide
Pharmaceutical Form: Oral Solution
Concentration: 10 mg/ml
Route of Administration: Oral use; Active Substance: Placebo
Pharmaceutical Form: Film-coated Tablet
Concentration: 50 mg
Route of Administration: Oral use; Active Substance: Placebo
Pharmaceutical Form: Oral Solution
Concentration: 10 mg/ml
Route of Administration: Oral use
Intervention MeSH terms: Lacosamide; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; Epilepsy; Children; Primary Generalized Tonic Clonic seizures; Idiopathic Generalized Epilepsy; Adults

Summary:

      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.
    

Eligibility criteria:

        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.