Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Levetiracetam; Topiramate
Intervention description: 250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks; 25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
Intervention MeSH terms: Topiramate; Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: levetiracetam; topiramate; epilepsy; partial seizures

Summary:

      To assess the long-term effects of levetiracetam on retention rate in subjects with
      refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant
      antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may
             only be included where legally permitted and ethically accepted

          -  Subjects with refractory epilepsy with partial onset seizure classifiable according to
             the International League Against Epilepsy (ILAE).

          -  Subjects having at least 2 partial onset seizures whether or not secondarily
             generalized during the 8 weeks historical baseline preceding V1 according to ILAE
             classification

          -  Subjects having at least 1 partial onset seizures whether or not secondarily
             generalized per 4 weeks preceding V2 according to ILAE classification

          -  Subjects with each interval of partial onset seizures less than 6 weeks during entire
             12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)

          -  Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.

          -  Permitted concomitant AEDs having been stable and at optimal dosage for the subject
             from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept
             stable during the Treatment Period.

        Exclusion Criteria:

          -  Subjects presenting any generalized epilepsies classified as type II according to the
             ILAE classification (ref to publication from 1981)

          -  Subjects suffering from epilepsies and syndromes undetermined whether focal or
             generalized (classification III according to the ILAE classification)

          -  Subjects suffering from special syndromes (classification IV according to the ILAE
             classification)

          -  History or occurring only in clusters (too frequently or indistinctly separated to be
             reliably counted) before V2.

          -  Presence of exclusively type IA non-motor seizures.

          -  History or presence of status epilepticus within last 3 months preceding V1 or during
             Baseline

          -  History or presence of known pseudo-seizures

          -  Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the
             past and have a normal visual field test are allowed.)

          -  Subject taking 1 or more of the following medications on a regular basis within 28
             days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine
             derivatives)