Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zonisamide
carbamazepine
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion criteria:
- Epilepsy patients over 15 years old.
- Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
- Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
- Female who can be in the month of pregnancy should agree to prevent conception.
- Patients who agree with Informed Consent Form.
Exclusion criteria:
- Patients who have Myoclonic seizures and/or Absence seizures.
- Patients who have progressive central nervous system (CNS) disorder.
- Patients who have serious systemic disorder.
- Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
- Patients who have renal stones.
- Medical history of medicinal poisoning and/or alcoholism.
- Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Sites / Locations
- Seoul National Univ. Bundang Hosp.
- Chungnam National Univ. Hosp.
- Dongguk Univ. Ilsan Hosp.
- Inha Univ. Hosp.
- Boramae Medical Center
- Eulji General Hosp.
- Ewha Womans Univ. Mokdong Hospital
- Hallym Univ. Medical Center
- Hanyang Univ. Medical Center
- Konkuk Univ. Medical Center
- Samsung Medical Center
- Seoul National Univ. Hosp.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The Percentage of Participants With Seizure Free Rate
The percentage of participants who had no seizure during the trial.
Secondary Outcome Measures
The Percentage of Participants With Retention Rate
The percentage of participants who completed the trial.
Quality of Life in Epilepsy (QoL-QOLIE31)
Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01127256
Brief Title
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Official Title
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 31, 2006 (Actual)
Primary Completion Date
May 31, 2009 (Actual)
Study Completion Date
July 31, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
zonisamide
Intervention Description
Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
Intervention Type
Drug
Intervention Name(s)
carbamazepine
Intervention Description
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Primary Outcome Measure Information:
Title
The Percentage of Participants With Seizure Free Rate
Description
The percentage of participants who had no seizure during the trial.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The Percentage of Participants With Retention Rate
Description
The percentage of participants who completed the trial.
Time Frame
24 weeks
Title
Quality of Life in Epilepsy (QoL-QOLIE31)
Description
Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Epilepsy patients over 15 years old.
Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
Female who can be in the month of pregnancy should agree to prevent conception.
Patients who agree with Informed Consent Form.
Exclusion criteria:
Patients who have Myoclonic seizures and/or Absence seizures.
Patients who have progressive central nervous system (CNS) disorder.
Patients who have serious systemic disorder.
Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
Patients who have renal stones.
Medical history of medicinal poisoning and/or alcoholism.
Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihee Mun
Organizational Affiliation
Medical Department, Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National Univ. Bundang Hosp.
City
Bundang
Country
Korea, Republic of
Facility Name
Chungnam National Univ. Hosp.
City
Chungnam
Country
Korea, Republic of
Facility Name
Dongguk Univ. Ilsan Hosp.
City
Ilsan
Country
Korea, Republic of
Facility Name
Inha Univ. Hosp.
City
Incheon
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Eulji General Hosp.
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans Univ. Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym Univ. Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang Univ. Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk Univ. Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National Univ. Hosp.
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
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