NCT01127256CompletedPhase 4
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eisai Korea Inc.
- Enrollment
- 200
- Locations
- 12
- Primary Endpoint
- The Percentage of Participants With Seizure Free Rate
Study Overview
Brief Summary
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
Detailed Description
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Experimental
Intervention: zonisamide (Drug)
2
Active Comparator
Intervention: carbamazepine (Drug)
Outcomes
Primary Outcomes
The Percentage of Participants With Seizure Free Rate
Time Frame: 24 weeks
The percentage of participants who had no seizure during the trial.
Secondary Outcomes
- The Percentage of Participants With Retention Rate(24 weeks)
- Quality of Life in Epilepsy (QoL-QOLIE31)(24 weeks)
Investigators
Study Sites (12)
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