Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Condition: Epilepsy; Monotherapy
MeSH terms: Epilepsy
Intervention: Lacosamide; Carbamazepine-Controlled Release
Intervention description: Lacosamide:
Strengths: 50 mg / 100 mg
Form: tablets
Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
Duration: up to 118 weeks; Carbamazepine-CR:
Strengths: 200 mg
Form: tablets
Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
Duration: up to 118 weeks
Intervention MeSH terms: Lacosamide; Carbamazepine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 888.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat®; Epilepsy; Monotherapy; Velocity

Summary:

      Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR)
      as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint
      of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance
      between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject able to comply with study requirements

          -  Subject is 16 years and older (female; male). Minors will be included in countries
             only if legally permitted

          -  Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures
             (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures
             separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1
             seizure occured 3 months preceding Visit 1

          -  Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT)
             scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months.
             If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they
             need to be completed and results must be available prior to randomization at Visit 2

        Exclusion Criteria:

          -  Subject has a history or presence of seizures of other types than partial-onset (IA,
             IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal
             origin) seizures (eg, myoclonic, absence)

          -  Subject has a history or presence of seizures occurring only in clustered patterns,
             defined as repeated seizures occurring over a short period of time (ie, < 20 minutes)
             with or without function regained between 2 ictal events

          -  Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of
             Idiopathic Generalized Epilepsy (IGE) at randomization

          -  Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or
             other nonepileptic ictal events that could be confused with seizures based on expert
             opinion and/or EEG evidence

          -  Subject has any medical or psychiatric condition

          -  Subject has a lifetime history of suicide attempt (including an actual attempt,
             interrupted attempt, or aborted attempt), or has 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 received treatment with Phenobarbital or Primidone within 28 days prior to
             Visit 1

          -  Subject is taking Benzodiazepines for a nonepilepsy indication

          -  Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including
             Benzodiazepines) in the last 6 months before Visit. However, acute and subacute
             seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was
             stopped at least 3 days prior to randomization

          -  Prior use of Felbamate or Vigabatrin is not allowed

          -  Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this
             time period, but not more frequently than once per week

          -  Subject has a medical condition that could reasonably be expected to interfere with
             drug absorption, distribution, metabolism, or excretion, has a history of alcohol or
             drug abuse within the previous 2 years

          -  Asian ancestry and tests positive for HLA-B*1502 allele

          -  Asian ancestry and tests positive for HLA-A*3101 allele