Epilepsy
Conditions
Brief summary
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
Interventions
DRUGzonisamide low dose group
Initial dose was 2mg/kg/day, increased after 1\ 2 weeks to 3\ 4mg/kg/day.
DRUGzonisamide high dose group
Initial dose was 2mg/kg/day, increased after 2\ 4 weeks to 6\ 8mg/kg/day.
Sponsors
Eisai Korea Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients with epilepsy whose age is 2\ 15 years old. 2. Patients had at least two seizures for the last 6 months before entry. 3. Patients who had never taken antiepileptic drugs. 4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG). 5. Agreement of the guardian is needed.
Exclusion criteria
1. Patients who have progressive central nervous system (CNS) disease. 2. Patients with serious disorder. 3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[SGOT\]) or (serum glutamic pyruvic transaminase \[SGPT\]) values more than twice the normal values. 4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values. 5. Hemolytic anemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Assessed As Seizure Free | 24 weeks | The percentage of participants who showed no seizure during the maintenance phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) | Baseline and 24 weeks | Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement. |
| Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) | Baseline and 24 weeks | The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems. |
| Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) | Baseline and 24 weeks | The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life. |
Countries
South Korea
Participant flow
Recruitment details
This study was recruited at 11 centers in Korea during the period of March 2006 to July 2009.
Participants by arm
| Arm | Count |
|---|---|
| Zonisamide Low Dose Group Initial dose was 2 mg/kg/day, increased after 1\
2 weeks to 3\
4 mg/kg/day. | 65 |
| Zonisamide High Dose Group Initial dose was 2 mg/kg/day, increased after 2\
4 weeks to 6\
8 mg/kg/day. | 60 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 10 | 8 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Zonisamide High Dose Group | Total | Zonisamide Low Dose Group |
|---|---|---|---|
| Age Continuous | 7.8 years STANDARD_DEVIATION 3 | 8.1 years STANDARD_DEVIATION 3 | 8.3 years STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants | 125 Participants | 65 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 | 26 Participants | 60 Participants | 34 Participants |
| Sex: Female, Male Male | 34 Participants | 65 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 65 | 18 / 60 |
| serious Total, serious adverse events | 2 / 65 | 1 / 60 |
Outcome results
Primary
Percentage of Participants Who Were Assessed As Seizure Free
The percentage of participants who showed no seizure during the maintenance phase.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zonisamide Low Dose Group | Percentage of Participants Who Were Assessed As Seizure Free | 63.1 percentage of participants |
| Zonisamide High Dose Group | Percentage of Participants Who Were Assessed As Seizure Free | 57.6 percentage of participants |
Secondary
Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children's behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zonisamide Low Dose Group | Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) | -5.259 Scores on a Scale | Standard Deviation 7.31 |
| Zonisamide High Dose Group | Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) | -1.611 Scores on a Scale | Standard Deviation 5.83 |
Secondary
Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zonisamide Low Dose Group | Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) | -1.3913 Scores on a Scale | Standard Deviation 9.13 |
| Zonisamide High Dose Group | Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) | 0.1071 Scores on a Scale | Standard Deviation 10.77 |
Secondary
Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.
Time frame: Baseline and 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zonisamide Low Dose Group | Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) | 4.7931 Scores on a Scale | Standard Deviation 0.167 |
| Zonisamide High Dose Group | Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) | 1.2286 Scores on a Scale | Standard Deviation 0.776 |