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

Eisai

Status and phase

Completed

Phase 4

Conditions

Epilepsy

Treatments

Drug: carbamazepine

Drug: zonisamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01127256

E2090-S082-405

Details and patient eligibility

About

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.

Full description

To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.

Enrollment

200 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Epilepsy patients over 15 years old.
Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
Female who can be in the month of pregnancy should agree to prevent conception.
Patients who agree with Informed Consent Form.

Exclusion criteria

Patients who have Myoclonic seizures and/or Absence seizures.
Patients who have progressive central nervous system (CNS) disorder.
Patients who have serious systemic disorder.
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.
Patients who have renal stones.
Medical history of medicinal poisoning and/or alcoholism.
Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.