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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: zonisamide
* Drug: carbamazepine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: zonisamide<br>* Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.<br>|
| Active Comparator: 2<br> | Drug: carbamazepine<br>* Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With Seizure Free Rate | The percentage of participants who had no seizure during the trial. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With Retention Rate | The percentage of participants who completed the trial. | 24 weeks | 
| Quality of Life in Epilepsy (QoL-QOLIE31) | Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life. | 24 weeks |