A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
Condition: Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long-term safety and efficacy of zonisamide used
      as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic
      drugs (AEDs).
    

Detailed description: 
      Those subjects who completed the double-blind study (E2090-E044-312) will be invited to
      participate in this extension study. The study consists of two main parts: Transition Period
      (double-blind) and Open Label Period. The study will start with the Transition Period during
      which subjects already on zonisamide will continue on the same dose of zonisamide and those
      who were taking placebo will be up-titrated to an appropriate dose of zonisamide. After all
      subjects have completed the Transition Period, the study will become open-label with every
      subject on the study receiving zonisamide. The study medication will be taken once daily in
      the evening. For those subjects previously in the placebo group, dosing with zonisamide will
      start with a dose of approximately 1 mg/kg. In order that the blind is maintained from the
      previous study, these subjects will initially continue taking the same number of placebo
      capsules as they were taking in the Maintenance Period of the E2090-E044-312 study until the
      up- titration is completed. Those subjects previously in the zonisamide arm will continue on
      the same dose which they received during the Maintenance Period of the E2090-E044-312 study.
      In order that the blind is maintained, they will also take placebo capsules in order to
      mirror the up- titration dose regimen of the subjects previously randomized to receive
      placebo in the E2090-E044-312 study. All subjects will stop taking placebo capsules after the
      Transition Period is complete. The duration of the Transition Period depends on the dose the
      subject appeared to have received when completing the core study E2090-E044-312. For those
      who completed on 8 mg/kg, the Transition Period will last 7 weeks. For those on 6 mg/kg, the
      Transition Period will last 5 weeks. However, during the double-blind Transition Period, some
      subjects may experience adverse events (AEs). If this should occur, the subject may be down
      titrated to one level above the minimal dose. The overall duration of the study will be up to
      59 weeks. The overall duration of the Transition Period may thus be as short as 2 weeks or
      prolonged to as many as 11 weeks.

      The Open Label Period will continue for up to a maximum of 59 weeks (approximately 15
      months).

      At the end of the study, Eisai will continue to supply zonisamide as part of this open-label
      extension protocol until the marketing authorisation of zonisamide for this indication or
      further development in this indication is stopped. In countries where no marketing
      authorisation will be applied for, Eisai has a compassionate use policy which can be applied
      for, if required.
    

Intervention name(s): Zonisamide
Intervention type(s): Drug
Intervention description(s): Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment