A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures
Condition: Epilepsy; Partial Onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide 50 mg; Lacosamide 100 mg; Placebo
Intervention description: Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 50 mg
Route of Administration: Oral use; Active Substance: Lacosamide
Pharmaceutical Form: Film-coated tablet
Concentration: 100 mg
Route of Administration: Oral use; Matching oral Placebo tablets twice daily for 16 weeks.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lacosamide; Epilepsy; Partial Onset Seizures

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of
      orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and
      Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary
      generalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT)
             scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy
             with Partial-Onset Seizures according to the International Classification of Epileptic
             Seizures (1981)

          -  Subject must have been observed to have Partial-Onset Seizures for at least the
             previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs
             (AEDs)(concurrently or sequentially) and must have been observed to have on average at
             least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21
             days in the 8-Week Period prior to entry into the Baseline Period. In the case of
             Simple Partial Seizures, only those with motor signs will be counted towards meeting
             the inclusion criterion

          -  Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs
             (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS
             must have been in place for at least 6 months prior to study entry. The dosage of
             concomitant AED therapy and the settings of the VNS must be kept constant for a period
             of at least 4 weeks prior to entry into the Baseline Period

          -  Minimum Body Weight of 40 kg

        Exclusion Criteria:

          -  Subject has a lifetime history of suicide attempt (including an active attempt,
             interrupted attempt, or aborted attempt) or has a 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 current or previous diagnosis of Pseudo-Seizures, Conversion Disorders,
             or other non-epileptical events that could be confused with Seizures

          -  Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting
             less than 30 minutes in which several Seizures occur with such frequency that the
             initiation and completion of each individual Seizure cannot be distinguished) during
             the 8-Week Period prior to Visit 1

          -  Subject has a history of Primary Generalized Seizures

          -  Subject with a history of Status Epilepticus within the 12-Months Period prior to
             Visit 1

          -  Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1

          -  Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric
             illness that may impair reliable participation in the study or necessitate the use of
             medication not allowed by the protocol