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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zonisamide | Drug | Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Seizure Free Rate | The percentage of participants who had no seizure during the trial. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Retention Rate | The percentage of participants who completed the trial. | 24 weeks |
| 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. |
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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 |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hosp. | Bundang | South Korea | ||||
| Dongguk Univ. Ilsan Hosp. |
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This study was recruited at 12 centers in Korea during the period of May 2006 to May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. |
| FG001 | Carbamazepine | Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| carbamazepine |
| Drug |
Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. |
|
| 24 weeks |
| Ilsan |
| South Korea |
| Inha Univ. Hosp. | Incheon | South Korea |
| Chungnam National Univ. Hosp. | Jungnam | South Korea |
| Boramae Medical Center | Seoul | South Korea |
| Eulji General Hosp. | Seoul | South Korea |
| Ewha Womans Univ. Mokdong Hospital | Seoul | South Korea |
| Hallym Univ. Medical Center | Seoul | South Korea |
| Hanyang Univ. Medical Center | Seoul | South Korea |
| Konkuk Univ. Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National Univ. Hosp. | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. |
| BG001 | Carbamazepine | Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | The Percentage of Participants With Seizure Free Rate | The percentage of participants who had no seizure during the trial. | Posted | Number | percentage of participants | 24 weeks |
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| Secondary | The Percentage of Participants With Retention Rate | The percentage of participants who completed the trial. | Posted | Number | percentage of participants | 24 weeks |
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| 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. | Posted | Mean | Standard Deviation | Units On a Scale | 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 | Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. | 5 | 96 | 74 | 96 | ||
| EG001 | Carbamazepine | Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. | 9 | 104 | 70 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Insomnia | Psychiatric disorders |
| |||
| Diabetic Ketoacidosis | Metabolism and nutrition disorders |
| |||
| Depressive Mood | Psychiatric disorders |
| |||
| Right Shoulder Injury | General disorders |
| |||
| Visual Hallucination | Psychiatric disorders |
| |||
| Cervical Sprain | General disorders |
| |||
| Memory And Judgement Disturbance | Psychiatric disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Dysuria | Renal and urinary disorders |
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| Constipation | Gastrointestinal disorders |
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| Uterine Fibroid | Reproductive system and breast disorders |
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| Sgpt Increased | Investigations |
| |||
| Sgot Increased | Investigations |
| |||
| Mental Torpor | Psychiatric disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
| |||
| Drowsiness | Psychiatric disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Weight Decrease | Investigations |
| |||
| Headache | Nervous system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Memory Impairment | Psychiatric disorders |
| |||
| Mental Torpor | Psychiatric disorders |
| |||
| Gastrointestinal Pain | Gastrointestinal disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Sleep Disorder | Psychiatric disorders |
| |||
| Fatigue | General disorders |
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| Pyrexia | General disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Diarrhoea | Gastrointestinal disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Dyspepsia | Gastrointestinal disorders |
|
Early termination leading to small numbers of subjects analyzed
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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 |
| 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 |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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