Epilepsy
Conditions
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.
Interventions
DRUGzonisamide
Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
DRUGcarbamazepine
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Sponsors
Eisai Korea Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Epilepsy patients over 15 years old. 2. Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months. 3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months. 4. Female who can be in the month of pregnancy should agree to prevent conception. 5. Patients who agree with Informed Consent Form.
Exclusion criteria
1. Patients who have Myoclonic seizures and/or Absence seizures. 2. Patients who have progressive central nervous system (CNS) disorder. 3. Patients who have serious systemic disorder. 4. 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. 5. Patients who have renal stones. 6. Medical history of medicinal poisoning and/or alcoholism. 7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With Seizure Free Rate | 24 weeks | The percentage of participants who had no seizure during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Epilepsy (QoL-QOLIE31) | 24 weeks | 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. |
| The Percentage of Participants With Retention Rate | 24 weeks | The percentage of participants who completed the trial. |
Countries
South Korea
Participant flow
Recruitment details
This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.
Participants by arm
| Arm | Count |
|---|---|
| Zonisamide Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. | 96 |
| Carbamazepine Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. | 104 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 13 |
| Overall Study | Lack of Efficacy | 4 | 0 |
| Overall Study | Lost to Follow-up | 16 | 17 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 9 |
Baseline characteristics
| Characteristic | Carbamazepine | Total | Zonisamide |
|---|---|---|---|
| Age, Continuous | 35.7 years STANDARD_DEVIATION 15.1 | 37.7 years STANDARD_DEVIATION 15.6 | 39.8 years STANDARD_DEVIATION 15.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 104 Participants | 200 Participants | 96 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 53 Participants | 102 Participants | 49 Participants |
| Sex: Female, Male Male | 51 Participants | 98 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 74 / 96 | 70 / 104 |
| serious Total, serious adverse events | 5 / 96 | 9 / 104 |
Outcome results
Primary
The Percentage of Participants With Seizure Free Rate
The percentage of participants who had no seizure during the trial.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zonisamide | The Percentage of Participants With Seizure Free Rate | 73.7 percentage of participants |
| Carbamazepine | The Percentage of Participants With Seizure Free Rate | 83.1 percentage of participants |
Secondary
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.
Time frame: 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zonisamide | Quality of Life in Epilepsy (QoL-QOLIE31) | Pre-QOLIE 31 | 60.72 Units On a Scale | Standard Deviation 14.69 |
| Zonisamide | Quality of Life in Epilepsy (QoL-QOLIE31) | Post-QOLIE 31 | 67.27 Units On a Scale | Standard Deviation 16.34 |
| Carbamazepine | Quality of Life in Epilepsy (QoL-QOLIE31) | Pre-QOLIE 31 | 61.96 Units On a Scale | Standard Deviation 16.67 |
| Carbamazepine | Quality of Life in Epilepsy (QoL-QOLIE31) | Post-QOLIE 31 | 69.51 Units On a Scale | Standard Deviation 17.61 |
Secondary
The Percentage of Participants With Retention Rate
The percentage of participants who completed the trial.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zonisamide | The Percentage of Participants With Retention Rate | 59.4 percentage of participants |
| Carbamazepine | The Percentage of Participants With Retention Rate | 62.5 percentage of participants |