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
NCT00292461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2013-05-20
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.
Conditions
Interventions
- DRUG
-
Zonisamide
Tablet once or twice daily orally for 16 weeks
- DRUG
-
Lamotrigine
Tablet once daily orally for 16 weeks
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Ya-Hui Cheng · Eisai Taiwan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2009-08-31
- Completion
- 2009-09-30
Countries
- China
Study Locations
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