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| ID | Type | Description | Link |
|---|---|---|---|
| TOPMATEPY4061 | Other Identifier | Janssen-Cilag Taiwan | |
| TOP-TWN-MA4 | Other Identifier | Janssen-Cilag Taiwan |
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The purpose of this study is to examine seizure control and tolerability of Topiramate after either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who is involved in the trial knows the study drug), parallel group trial. The study has three phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks) and maintenance period (8 weeks). After qualifying for trial entry in the retrospective baseline phase, eligible patients will be randomized in 1:1 ratio to receive either topiramate add-on therapy or topiramate monotherapy. During the titration period (period in which the dose of the study drug is increased or decreased at the discretion of investigator), topiramate, given as morning doses, will be started with daily doses of 25 mg/day for one week. After that, topiramate will be given as morning and evening doses, and the doses will be gradually increased every week to reach the initial target dose of 200 mg/day at the end of titration period. During the maintenance period, the dose of topiramate could be increased or decreased according to the investigator's judgment. Patients should keep seizure diaries during the 16 weeks of topiramate treated period and are followed with once monthly visits to the clinic, at which safety will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate add-on therapy | Active Comparator |
| |
| Topiramate monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate add-on therapy | Drug | Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4 | Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period. | Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Taiwan Clinical Trial | Janssen-Cilag Taiwan | Study Director |
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55 participants were randomly assigned to receive either topiramate monotherapy or add-on therapy at 6 sites in Taiwan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate Monotherapy | Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. |
| FG001 | Topiramate add-on Therapy | Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate Monotherapy | Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. |
| 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 | Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4). | Intent-To-Treat population: All randomized participants who received at least one dose of study medication. | Posted | Number | Percentage of participants | Month 4 |
|
20 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 | Topiramate Monotherapy | Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herniated Intervertebral Disc | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
No limitations were reported in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen-Cilag Taiwan | 886 2 23762155 |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009422 | Nervous System Diseases |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Topiramate monotherapy | Drug | Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use. |
|
| Dosage Administration of Topamax During Month 4 | Month 4 |
| Seizure frequency doubled |
|
| Protocol Violation |
|
| BG001 |
| Topiramate add-on Therapy |
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
|
|
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| Secondary | Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4 | Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period. | Intent-To-Treat population: All randomized participants who received at least one dose of study medication. | Posted | Mean | Standard Deviation | Percent change | Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4 |
|
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|
|
| Secondary | Dosage Administration of Topamax During Month 4 | Participants who have received study medication during month 4. | Posted | Mean | Standard Deviation | mg | Month 4 |
|
|
|
| 1 |
| 35 |
| 33 |
| 35 |
| EG001 | Topiramate add-on Therapy | Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8. | 1 | 20 | 20 | 20 |
| Osteomyelitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Decreased appetite | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| D013568 | Pathological Conditions, Signs and Symptoms |