Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

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

Details

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

Criteria

Inclusion criteria:

1. Epilepsy patients over 15 years old.

2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.

3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.

4. Female who can be in the month of pregnancy should agree to prevent conception.

5. Patients who agree with Informed Consent Form.

Exclusion criteria:

1. Patients who have Myoclonic seizures and/or Absence seizures.

2. Patients who have progressive central nervous system (CNS) disorder.

3. Patients who have serious systemic disorder.

4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.

5. Patients who have renal stones.

6. Medical history of medicinal poisoning and/or alcoholism.

7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.