Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Korea Inc.
• Treatments: Zonisamide

Criteria

Inclusion criteria:

1. Epilepsy patient over 15 years old who agrees with Informed Consent Form

2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.

3. Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).

4. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.

5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.

Exclusion criteria:

1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.

2. Patient who experiences pseudoseizures and/or who has uncountable clusters.

3. Patient who has serious systemic or drug metabolism affecting disorder .

4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.

5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.

6. Patient who has medical history of renal stones.

7. Patient who is allergic to sulfonamide.

8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.

9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.

10. A terminal patient and/or a scheduled surgical patient.

11. Patient who has medication history of zonisamide.

12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.