A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Official Title
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A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Zonisamide
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects must sign and date the informed consent form Clinical diagnosis as refractory epilepsy Exclusion criteria: Progressive neurologic disease Serious psychiatric disease Hemolytic anemia G6PD (glucose-6-phosphate dehydrogenase) deficiency Acute intermittent porphyrias Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past Drug or alcohol addiction Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST > 2x ULN) Stevens-Johnson syndrome Progressive exfoliative dermatitis Pregnant, lactating or of childbearing potential female Regularly taking oral contraceptives Hypersensitivity to study drugs Severe cardiac disease (New York Heart Association Functional Class III and IV) History of malignancy within 5 years Taking valproic acid within 7 days prior to screening Subjects with simple partial seizures without motor component

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: zonisamide<br>tablet | Drug: Zonisamide<br>* Tablet once or twice daily orally for 16 weeks<br>|
| Active Comparator: lamotrigine<br>tablet | Drug: Lamotrigine<br>* Tablet once daily orally for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline | Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment | Baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period |  | Baseline and 16 weeks | 
| Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period |  | Baseline and 16 weeks | 
| Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. |  | Baseline and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, seizures