eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Lacosamide
Intervention description: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
Maximum duration of study drug administration is approximately 23 weeks.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lacosamide; Epilepsy; Levetiracetam; Sodium Channel Blockers

Summary:

      The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide
      (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with
      withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects
      not well controlled on their current regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female, at least 18 years of age

          -  Subject has a diagnosis of epilepsy with partial-onset seizures according to the
             International Classification of Epileptic Seizures (1981)

          -  Subject is taking levetiracetam (LEV) in combination with 1 sodium channel blocking
             antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin,
             or eslicarbazepine) as adjunctive treatment for epilepsy

          -  The minimum required seizure frequency during the 8-week Retrospective Seizure
             Baseline is on average ≥ 2 partial-onset seizures per 28 days with at least 1 seizure
             per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally,
             subjects must experience at least 1 seizure during the 4-week Prospective Seizure
             Baseline

          -  Subject has been maintained on a stable dose of LEV and a sodium channel blocking
             antiepileptic drug (SCB-AED) for at least 4 weeks prior to the Screening Visit (Visit
             1) and during the 4-week Prospective Seizure Baseline

          -  The minimum required seizure frequency during the 8-week Retrospective Seizure
             Baseline is on average ≥ 2 partial-onset seizures per 28 days (based on investigator
             assessment of subject report) with at least 1 seizure per 4 week period within the
             8-week Retrospective Seizure Baseline

          -  Subject has been maintained on a stable dose of levetiracetam (LEV) and a sodium
             channel blocking antiepileptic drug (SCB-AED) for at least 4 weeks prior to the
             Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline, with or
             without additional concurrent stable vagal nerve stimulation (VNS). The VNS must have
             been in place for at least 6 months prior to the Screening Visit (Visit 1) with
             constant settings for at least 4-weeks prior to the Screening Visit (Visit 1) and
             throughout the duration of the study

        Exclusion Criteria:

          -  Previous use of lacosamide

          -  History of alcohol or drug abuse

          -  History of seizure disorder characterized primarily by isolated auras

          -  History of primary generalized seizures

          -  History of status epilepticus within the 12-months

          -  History of clustering seizures

          -  Nonepileptic events, including pseudoseizures that could be confused with seizures

          -  History of any medical or psychiatric condition that, in the opinion of the
             investigator, could jeopardize the subject's health or would compromise the subject's
             ability to participate in this study

          -  Lifetime history of suicide attempt, or suicidal ideation in the past 6 months

          -  Hypersensitivity to any component of lacosamide (LCM)

          -  History of acute or sub-acute progressive central nervous system disease

          -  History of severe anaphylactic reaction or serious blood dyscrasias

          -  Impaired renal function (ie, Creatinine Clearance (CLcr) is lower than 30 mL/min) at
             Visit 1

          -  History of sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or
             subject has any other clinically significant electrocardiogram (ECG) abnormalities

          -  History sodium channelopathy, such as Brugada syndrome

          -  History of myocardial infarction in the last 3 months