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The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zonisamide Low Dose Group | Experimental |
| |
| Zonisamide High Dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zonisamide low dose group | Drug | Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were Assessed As Seizure Free | The percentage of participants who showed no seizure during the maintenance phase. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihee Mun | Medical Department, Eisai Korea Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongsan Medical Center of Keimyung Univ. | Seoul | South Korea | ||||
| Gangnam Severance Hospital |
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This study was recruited at 11 centers in Korea during the period of March 2006 to July 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide Low Dose Group | Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day. |
| FG001 | Zonisamide High Dose Group | Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide Low Dose Group | Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day. |
| BG001 | Zonisamide High Dose Group | Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Were Assessed As Seizure Free | The percentage of participants who showed no seizure during the maintenance phase. | Posted | Number | percentage of participants | 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide Low Dose Group | Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jihee Mun, Pharmacist, Medical Department manager | Eisai Korea Inc. | +82-2-3451-5531 | jihee_mun@eisaikorea.com |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| zonisamide high dose group | Drug | Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day. |
|
| 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. | Baseline and 24 weeks |
| 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. | Baseline and 24 weeks |
| Seoul |
| South Korea |
| Inje Univ. Ilsan-Paik Hospital | Seoul | South Korea |
| Inje Univ. Sanggye-Paik Hospital | Seoul | South Korea |
| Korea Univ. Ansan Hospital | Seoul | South Korea |
| Korea Univ. Guro Hospital | Seoul | South Korea |
| National Health Insurance Corporation Ilsan Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Soonchunhyang Univ. Cheonan Hospital | Seoul | South Korea |
| Soonchunhyang Univ. Hospital | Seoul | South Korea |
| Yeungnam University Medical Center | Seoul | South Korea |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and 24 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and 24 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline and 24 weeks |
|
|
|
| 2 |
| 65 |
| 14 |
| 65 |
| EG001 | Zonisamide High Dose Group | Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day. | 1 | 60 | 18 | 60 |
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Acute gastroenteritis | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Micturition Disorder | Renal and urinary disorders |
|
| Headache | Nervous system disorders |
|
| Weight Decrease | General disorders |
|
| Memory Impairment | Psychiatric disorders |
|
| Dysaesthesia | Nervous system disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Gastrointestinal Pain | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Anxiety | Psychiatric disorders |
|
| Sweating Decreased | Skin and subcutaneous tissue disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
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| Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003710 | Demography |
| D011154 | Population Characteristics |