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The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zonisamide | Drug | zonisamide 100 mg tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Seizure Reduction Rate | The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Free Rate | The percentage of the participants who experienced no seizure during the trial. | 16 weeks |
| Responder Rate | The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%. |
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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 |
|---|---|---|---|---|---|---|
| Dong-A University Hospital, Dept. of Neurology | Busan | South Korea | ||||
| Inje Univ. Pusan Paik Hospital, Dept. of Neurology |
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This study was recruited at 10 centers in Korea during the period of February 2008 to August 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and 16 weeks |
| QoL-QOLIE31 (Quality of Life in Epilepsy) | 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. | Baseline and 16 weeks |
| Busan |
| South Korea |
| Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology | Daegu | South Korea |
| Kyungpook Natl. Univ. Hosp., Dept. of Neurology | Daegu | South Korea |
| Yeungnam Univ. Medical Center, Dept. of Neurology | Daegu | South Korea |
| Gachon Medical School Gil Medical Centre, Dept.of Neurology | Incheon | South Korea |
| Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology | Koyang | South Korea |
| Bundang CHA Hospital, Dept. of Neurology | Seongnam | South Korea |
| Kangdong Sacred Heart Hosp., Dept. of Neurology | Seoul | South Korea |
| Severance Hospital, Dept. of Neurology | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Seizure Reduction Rate | The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency. | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Posted | Mean | Standard Deviation | Percentage of Seizure Reduction Rate | Baseline and 16 weeks |
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| Secondary | Seizure Free Rate | The percentage of the participants who experienced no seizure during the trial. | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Posted | Number | Percentage of Participants | 16 weeks |
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| Secondary | Responder Rate | The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%. | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. | Posted | Number | Percentage of Participants | Baseline and 16 weeks |
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| Secondary | QoL-QOLIE31 (Quality of Life in Epilepsy) | 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. | Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and 16 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 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day. | 2 | 121 | 78 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ligament rupture | Injury, poisoning and procedural complications |
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| Brain contusion | Injury, poisoning and procedural complications |
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| Rib fracture | Injury, poisoning and procedural complications |
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| Skin laceration | Injury, poisoning and procedural complications |
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| Diverticulitis | Infections and infestations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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| Somnolence | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Vomiting | Gastrointestinal disorders |
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| Anorexia | Metabolism and nutrition disorders |
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| Asthenia | General disorders |
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| Weight decreased | Investigations |
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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 |
| 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 |
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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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