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
Intervention: Zonisamide
Intervention description: Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.
Intervention MeSH terms: Zonisamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Subject has completed the double-blind study E2090-E044-312.

          2. Parent/caregiver is willing to sign an informed consent where the subject is under the
             age of consent.

          3. Subject is male or female aged 6 to 18 years who is willing to give informed (written
             or verbal) assent, if applicable. If mandated by local regulations, subjects of
             relevant age will be required to sign an appropriate informed consent.

          4. Subject is in general good health as determined by medical history, physical exam and
             screening laboratory results.

        EXCLUSION CRITERIA:

          1. Subject has a body weight < 20 kg.

          2. Subject has developed a history of renal calculi or renal insufficiency (creatinine
             level > 135 µmol/l (1.5 mg/dl).

          3. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or
             C.

          4. Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its
             excipients.

          5. Female subject of 10 years of age or greater, or of child bearing potential (i.e.
             started menses) and is not taking or prepared to take a medically acceptable form of
             contraception (i.e. oral contraceptive pill, surgical sterilization, an implant or
             injected form of contraception, or intrauterine device), or who is not prepared to
             abstain from sexual activity for the duration of the study and for one month after the
             last administration of study medication. NOTE: Should a female subject become of child
             bearing potential during the study, they must be reconsented in order to given consent
             to undergo pregnancy testing and either confirm abstinence or receive a medically
             appropriate form of contraception.

          6. Subject has a recent history of excessive alcohol use or drug abuse.

          7. Subject has a history of suicide attempt.

          8. Subject has a clinically significant organic disease.

          9. Subject has a history of demonstrated non-compliance with treatment or subject or
             parent/legal guardian can be reasonably expected not to be compliant with study
             procedures or to complete the study.

         10. Frequent need of rescue benzodiazepines (one or more times a month).

         11. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate,
             furosemide and drugs with anticholinergic activity.

         12. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of
             the E2090-E044-312 study.