Status:
COMPLETED
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
Lead Sponsor:
Eisai Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00292461
Start Date
March 1 2006
End Date
September 1 2009
Last Update
May 20 2013
Active Locations (8)
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1
Changhua Christian Hospital
Changhua, Taiwan, China
2
Chang-Gung Memorial Hospital (CGMH)
Kaohsiung, Taiwan, China
3
Chang-Gung Memorial Hospital (CGMH)
Linkou, Taiwan, China
4
China Medical University Hospital (CMUH)
Taichun, Taiwan, China