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The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zonisamide | Active Comparator | tablet |
|
| lamotrigine | Active Comparator | tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zonisamide | Drug | Tablet once or twice daily orally for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline | Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period | Baseline and 16 weeks | |
| Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period | Baseline and 16 weeks |
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Inclusion criteria:
Exclusion criteria:
Progressive neurologic disease
Serious psychiatric disease
Hemolytic anemia
G6PD (glucose-6-phosphate dehydrogenase) deficiency
Acute intermittent porphyrias
Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past
Drug or alcohol addiction
Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST > 2x ULN)
Stevens-Johnson syndrome
Progressive exfoliative dermatitis
Pregnant, lactating or of childbearing potential female
Regularly taking oral contraceptives
Hypersensitivity to study drugs
Severe cardiac disease (New York Heart Association Functional Class III and IV)
History of malignancy within 5 years
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| Name | Affiliation | Role |
|---|---|---|
| Ya-Hui Cheng | Eisai Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | China | |||
| Chang-Gung Memorial Hospital (CGMH) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zonegran | once or twice daily orally for 16 weeks |
| FG001 | Lamotrigine | once daily orally for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lamotrigine |
| Drug |
Tablet once daily orally for 16 weeks |
|
| Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. | Baseline and 16 weeks |
| Kaohsiung |
| Taiwan |
| China |
| Chang-Gung Memorial Hospital (CGMH) | Linkou | Taiwan | China |
| China Medical University Hospital (CMUH) | Taichun | Taiwan | China |
| National Cheng Kung University Hospital | Tainan | Taiwan | China |
| Chang-Gung Memorial Hospital (CGMH) | Taipei | Taiwan | China |
| Taipei Tzu Chi General Hospital | Taipei | Taiwan | China |
| Taipei Veterans General Hospital | Taipei | Taiwan | China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zonegran | once or twice daily orally for 16 weeks |
| BG001 | Lamotrigine | once daily orally for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline | Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment | ITT (intent-to-treat) | Posted | Median | Full Range | percent change | Baseline and 16 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period | Posted | Number | participants | Baseline and 16 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period | Posted | Number | participants | Baseline and 16 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. | Posted | Number | percentage of participants | 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 | Zonegran | once or twice daily orally for 16 weeks | 0 | 34 | 20 | 34 | ||
| EG001 | Lamotrigine | once daily orally for 16 weeks | 1 | 30 | 20 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumber contusion | Musculoskeletal and connective tissue disorders |
| |||
| nystagmus | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disturbance in attention | Nervous system disorders | Derived from Table for all drug-related AEs |
| ||
| dizziness | Nervous system disorders | Derived from Table for all drug-related AEs |
| ||
| Gait disturbance | Nervous system disorders | Derived from Table for all drug-related AEs |
| ||
| insomnia | Nervous system disorders | Derived from Table for all drug-related AEs |
| ||
| nystagmus | Nervous system disorders | Derived from Table for all drug-related AEs |
| ||
| somnolence | Nervous system disorders | derived from Table for all drug-related AEs |
| ||
| White blood cell urine positive | Investigations | Derived from Table for all drug-related AEs |
| ||
| Blood alkaline phosphatase increased | Investigations | Derived from Table for all drug-related AEs |
| ||
| Electrocardiogram abnormal | Investigations | Derived from Table for all drug-related AEs |
| ||
| Hepatic enzyme abnormal | Investigations | Derived from Table for all drug-related AEs |
| ||
| Red blood cell urine positive | Investigations | Derived from Table for all drug-related AEs |
| ||
| Weight decreased | Investigations | Derived from Table for all drug-related AEs |
| ||
| Mood altered | Psychiatric disorders | Derived from Table for all drug-related AEs |
| ||
| nausia | Gastrointestinal disorders | Derived from Table for all drug-related AEs |
| ||
| Abdominal distention | Gastrointestinal disorders | Derived from Table for all drug-related AEs |
| ||
| anorexia | Metabolism and nutrition disorders | Derived from Table for all drug-related AEs |
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| malaise | General disorders | Derived from Table for all drug-related AEs |
| ||
| splenomegaly | Blood and lymphatic system disorders | Derived from Table for all drug-related AEs |
| ||
| Hepatic function disorders | Hepatobiliary disorders | Derived from Table for all drug-related AEs |
| ||
| contusion | Musculoskeletal and connective tissue disorders | Derived from Table for all drug-related AEs |
| ||
| pruritus | Skin and subcutaneous tissue disorders | Derived from Table for all drug-related AEs |
| ||
| rash | Skin and subcutaneous tissue disorders | Derived from Table for all drug-related AEs |
| ||
| diplopia | Eye disorders | Derived from Table for all drug-related AEs |
| ||
| Vision blurred | Eye disorders | Derived from Table for all drug-related AEs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takao Ishii, Asia regulatory affaires | Eisai Co., Ltd. | 81-3-3817-3914 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| D000077213 | Lamotrigine |
| 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 |
| D014227 | Triazines |
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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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