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
Epilepsy
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, seizures
Eligibility Criteria
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
Sites / Locations
- Changhua Christian Hospital
- Chang-Gung Memorial Hospital (CGMH)
- Chang-Gung Memorial Hospital (CGMH)
- China Medical University Hospital (CMUH)
- National Cheng Kung University Hospital
- Chang-Gung Memorial Hospital (CGMH)
- Taipei Tzu Chi General Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
zonisamide
lamotrigine
tablet
tablet