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
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Zonisamide (Drug); Lamotrigine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): Ya-Hui Cheng, Study Director, Affiliation: Eisai Taiwan
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 generalized seizures.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
Secondary outcome: Global Assessment of Efficacy by Physician at the End of 16-week Treatment PeriodGlobal Assessment of Efficacy by Participants at the End of the 16-week Treatment Period Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
Eligibility
Minimum age: 16 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Changhua Christian Hospital, Changhua, Taiwan, China
Chang-Gung Memorial Hospital (CGMH), Kaohsiung, Taiwan, China
Chang-Gung Memorial Hospital (CGMH), Linkou, Taiwan, China
China Medical University Hospital (CMUH), Taichun, Taiwan, China
National Cheng Kung University Hospital, Tainan, Taiwan, China
Chang-Gung Memorial Hospital (CGMH), Taipei, Taiwan, China
Taipei Tzu Chi General Hospital, Taipei, Taiwan, China
Taipei Veterans General Hospital, Taipei, Taiwan, China
Additional Information
Starting date: March 2006
Last updated: May 13, 2013
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