Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Levetiracetam; Oxcarbazepine
Intervention description: 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks; 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)
Intervention MeSH terms: Oxcarbazepine; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 353.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Levetiracetam; Oxcarbazepine; treatment failure; partial epilepsy

Summary:

      To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment
      Failure Rate in subjects with newly diagnosed partial onset seizures with or without
      secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks
      from the first dose
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g.,
             under 20 years or subject with learning disability but judged to be capable to
             understand) may only be included where legally permitted and ethically accepted

          -  Subjects with newly or recently diagnosed epilepsy having experienced unprovoked
             partial seizures (IA, IB, IC with clear focal origin), that are classifiable according
             to the International Classification of Epileptic seizure (1981). Undiscriminated
             subjects between IC and IIE could be included

          -  Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the
             year preceding randomization out of which at least 1 unprovoked seizure in the 6
             months preceding randomization

          -  Subjects with documented evidence of EEG and brain MRI or CT scan in medical records
             which were performed within 1 year prior to Visit 1 (V1)

          -  Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this
             study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks
             duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital
             and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

        Exclusion Criteria:

          -  Subject has a current or previous diagnosis of pseudoseizures, conversion disorders,
             or other non-epileptic ictal events which could be confused with seizures

          -  Subject taking 1 or more of the following medications on a regular basis within 28
             days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic
             analgesics

          -  Subject taking any immunosuppressant within 28 days prior to Visit 1

          -  Subject has a history of suicide attempt, has received professional counseling for
             suicidal ideation, or is currently experiencing active suicidal ideation

          -  Subject has a seizure disorder characterized primarily by isolated auras (ie, simple
             partial seizures without observable motor signs)

          -  Subject suffering from seizures other than partial (IA, IB, IC, with clear focal
             origin) seizures

          -  Subject has a history of status epilepticus within last 3-month period prior to Visit
             1

          -  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 12-week period prior to Visit 1 and/or during the Screening Period

          -  Body weight is lower than 40 kg (< 40 kg)