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| ID | Type | Description | Link |
|---|---|---|---|
| TOPMATEPY4053 |
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The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), observational (a clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) and multi-center (when more than one hospital or medical school team work on a medical research study) study of topiramte in participants with epilesy. The study population will be all the epilepsy participants visiting outpatient study center over a period of two months. Topiramate will be administered as per Investigator's discretion for 52 weeks. Participants will visit the trial site for evaluation of endpoint at Baseline, Week 12, Week 26, and Week 52. Efficacy will primarily be evaluated by percentage of participants which will be retained to topiramate treatment uptil Week 52. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Retained to Topiramate Treatment | Participants with long term retention of topiramate until 52 weeks were reported | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Number of participants who received concomitant AEDs along with the topiramate were reported. | Baseline up to Week 52 |
| Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include participants with epilepsy who visit an out-patient clinic for two months and have not received topiramate treatment for at least three months prior to Screening.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) population included all participants who met all the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed. |
| 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 Retained to Topiramate Treatment | Participants with long term retention of topiramate until 52 weeks were reported | The full analysis set (FAS) population included all participants who met all the eligibility criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
|
|
Baseline up to Week 52
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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 | This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
The study design is single arm and open label, so bias could not be excluded in the subjective evaluation by Participants and Investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate, Medical affairs | Janssen Korea, Location: 25F, LS , Yongsan Tower, 191, Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea | 82-2-2094-4837 |
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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 |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported. |
| Baseline up to Week 52 |
| Percentage of Participants Without Seizure | Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52. | Baseline up to Week 52 |
| Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported. | Week 52 |
| Lost to Follow-up |
|
| Adverse Event |
|
| tapering of topiramate |
|
| Other |
|
| Low compliance |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Number of participants who received concomitant AEDs along with the topiramate were reported. | FAS population included all participants who met all the eligibility criteria. | Posted | Number | Participants | Baseline up to Week 52 |
|
|
|
| Secondary | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported. | FAS population included all participants who met all the eligibility criteria. | Posted | Number | Participants | Baseline up to Week 52 |
|
|
|
| Secondary | Percentage of Participants Without Seizure | Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52. | FAS population included all participants who met all the eligibility criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to Week 52 |
|
|
|
| Secondary | Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported. | FAS population included all participants who met all the eligibility criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
|
|
|
| 8 |
| 1,234 |
| 34 |
| 1,234 |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Weight decreased | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
PI cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
| Carbohydrates |
| D007661 | Ketoses |
| Title | Measurements |
|---|---|
|