Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Zonisamide; Carbamazepine
Intervention description: Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.; Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
Intervention MeSH terms: Carbamazepine; Zonisamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Epilepsy; Monotherapy

Summary:

      The purpose of this study is to assess the long-term safety and tolerability and to explore
      the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly
      diagnosed partial seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has completed study E2090-E044-310.

          2. Subject is able and willing to give written informed consent.

          3. Female subjects without childbearing potential (two years post-menopausal, bilateral
             oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects
             of childbearing potential must be non-pregnant, non-lactating and abide by one of the
             following medically acceptable contraceptive measures: oral contraceptive pill,
             contraceptive injections, implants or patches, intrauterine device in place for at
             least three months, vasectomised partner or abstinence throughout the study and for
             one month after discontinuation of study medication. When the contraceptive pill is
             used, this should contain no less than 50 μg oestrogen.

          4. The subject is able and willing to follow the investigational study procedures,
             maintain a seizure diary and report adverse events.

        Exclusion Criteria:

          1. Subject has a history of a significant or currently uncontrolled disease that will
             contraindicate the use of the study drugs or interfere with the conduct of this study
             and/or the assessment of safety and efficacy of the study drugs.

          2. Subject has a body weight <40 kg.

          3. Subject has a newly occurring progressive malignancy during study E2090-E044-310
             (excluding a history of non-metastasized and adequately treated cutaneous squamous
             cell carcinoma).

          4. Subject has developed a psychiatric illness or mood disorder requiring
             electro-convulsive or drug therapy within the previous 6 months and is considered
             uncontrolled; history of suicide attempt, alcohol or drug abuse, chronic treatment
             with benzodiazepines or barbiturates.

          5. Subject is currently taking carbonic anhydrase inhibitors.

          6. Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically
             significant laboratory abnormalities, stroke or uncontrolled hypertension during study
             E2090-E044-310.

          7. Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded
             medications (see protocol section 9.9.3).

          8. Subject has a history of allergy to carbamazepine or to zonisamide or to any of their
             ingredients or to sulphonamides.

          9. Subject has developed a bone marrow depression, low platelet count or other blood
             dyscrasias.