Conditions: Epilepsy
Keywords: Epilepsy Monotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 295
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Zonisamide intervention 2: Carbamazepine
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: