An observational study in Epilepsy, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 1,234 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Drug: Topiramate
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
Percentage of Participants Retained to Topiramate Treatment
Participants with long term retention of topiramate until 52 weeks were reported
Time frame: Week 52
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
Number of participants who received concomitant AEDs along with the topiramate were reported.
Time frame: Baseline up to Week 52
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 52
| Milestone | Topiramate |
|---|---|
| Started | 1234 |
| Treated | 1232 |
| Completed | 902 |
| Not completed | 332 |
| Withdrew: Lack of efficacy | 62 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Moved to other hospital | 10 |
| Withdrew: Lost to follow-up | 174 |
| Withdrew: Adverse event | 46 |
| Withdrew: Tapering of topiramate | 5 |
| Withdrew: Other | 21 |
| Withdrew: Low compliance | 13 |
Participants with long term retention of topiramate until 52 weeks were reported
| Percentage of participants | Topiramate |
|---|---|
| Percentage of Participants Retained to Topiramate Treatment | 71.56 (68.95 to 73.99) |
Number of participants who received concomitant AEDs along with the topiramate were reported.
| Participants | Topiramate |
|---|---|
| Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | 749 |
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.
| Participants | Topiramate |
|---|---|
| First Mono-therapy | 507 ± 0 |
| Second Mono-therapy | 64 |
| Add-on therapy | 661 |
Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.
| Percentage of participants | Topiramate |
|---|---|
| Percentage of Participants Without Seizure | 40.50 (37.76 to 43.24) |
Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
| Percentage of participants | Topiramate |
|---|---|
| Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | 84.20 (82.10 to 86.30) |
Collected over Baseline up to Week 52. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topiramate | — | 8/1,234 (0.6%) | 34/1,234 (2.8%) |
| Event | Topiramate |
|---|---|
| DeathGeneral disorders | 5/1234 |
| Decreased appetiteMetabolism and nutrition disorders | 1/1234 |
| Duodenal ulcer perforationGastrointestinal disorders | 1/1234 |
| Hepatic neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1234 |
| Event | Topiramate |
|---|---|
| ParaesthesiaNervous system disorders | 19/1234 |
| Weight decreasedNervous system disorders | 16/1234 |
Full analysis set (FAS) population included all participants who met all the eligibility criteria.
| Age Continuous(Years) | Topiramate |
|---|---|
| Mean | 24.07 ± 17.10 |
| Sex: Female, Male(Participants) | Topiramate |
|---|---|
| Female | 562 |
| Male | 670 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Korea, Ltd., Korea