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

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

Detailed Description
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The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100   400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Official Title
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A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: zonisamide


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Epilepsy patient over 15 years old who agrees with Informed Consent Form Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures. 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). Patient who takes 1   3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks. Exclusion criteria: Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain. Patient who experiences pseudoseizures and/or who has uncountable clusters. Patient who has serious systemic or drug metabolism affecting disorder . Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3. Patient who has medical history of renal stones. Patient who is allergic to sulfonamide. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception. A terminal patient and/or a scheduled surgical patient. Patient who has medication history of zonisamide. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: zonisamide<br>* zonisamide 100 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Reduction Rate | The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency. | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Free Rate | The percentage of the participants who experienced no seizure during the trial. | 16 weeks | 
| Responder Rate | The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%. | Baseline and 16 weeks | 
| QoL-QOLIE31 (Quality of Life in Epilepsy) | 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. | Baseline and 16 weeks |