Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
Condition: Partial Epilepsies
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Lacosamide
Intervention description: Oral Lacosamide:
Subjects Titration Phase (6 Weeks):
Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid
Maintenance Phase (24 Weeks):
200 mg tablet bid OR 150 mg tablet bid
Taper Phase (1 - 3 Weeks):
50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Intervention MeSH terms: Lacosamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 461.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Epilepsy Treatment; Anti-epileptic drugs; Seizures; Vimpat

Summary:

      To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects
      with uncontrolled partial-onset seizures after prior treatment with a monotherapy
      Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at
      least 2 AEDs.
    

Eligibility criteria:

        Inclusion Criteria:

        Group 1:

          -  Subject has a diagnosis of epilepsy with simple partial seizures (motor component)
             and/or complex partial seizures with or without secondary generalization

          -  Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED)
             for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior
             use of rescue medication (short-term intermittent use) is acceptable

          -  Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit

          -  The minimum allowed seizure frequency at any time during the 12 weeks prior to the
             Screening Visit is ≥3 partial-onset seizures

        Group 2:

          -  Subject has a diagnosis of epilepsy with simple partial seizures (motor component)
             and/or complex partial seizures with or without secondary generalization

          -  Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens
             (concurrently or sequentially)

          -  Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit

          -  The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit
             is ≥1 partial-onset seizure per 28 days

        Exclusion Criteria:

          -  Previous use of Lacosamide

          -  History of seizure disorder characterized primarily by isolated auras

          -  History of primary generalized seizures

          -  History of status epilepticus within last 12-months

          -  History of cluster seizures during the 12 week period prior to Visit 1

          -  Nonepileptic events, including pseudoseizures that could be confused with seizure

          -  Lifetime history of suicide attempt or suicidal ideation in the past 6 months

          -  Hypersensitivity to any component of Lacosamide

          -  History of drug or alcohol abuse

          -  History of an acute or subacutely progressive Central Nervous System (CNS) disease

          -  Undergone cranial surgery within the last year prior to study entry

          -  Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6
             months

          -  Prior or concomitant Vigabatrin use