Epilepsy
Conditions
Keywords
Epilepsy, Topiramate, Topmax
Brief summary
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
Detailed description
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.
Interventions
DRUGTopiramate
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants with all type of epilepsy * Participants with more than 2 episodes of seizure during last 1 year * Participants who can comply with the visit schedule and are willing and able to complete evaluation procedures specified in the protocol during the treatment period * Female participants with child bearing potential and who use proper contraceptive methods during the study period
Exclusion criteria
* Participants who have known hypersensitivity reaction or allergy to the study drug * Participants who have taken topiramate within the three months of study start * Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion * Pregnant and nursing female participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Retained to Topiramate Treatment | Week 52 | Participants with long term retention of topiramate until 52 weeks were reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | Baseline up to Week 52 | Number of participants who received concomitant AEDs along with the topiramate were reported. |
| Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Baseline up to Week 52 | 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. |
| Percentage of Participants Without Seizure | Baseline up to Week 52 | 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 With Reduction in Seizure Frequency by 50 Percent or More | Week 52 | Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topiramate This was an observational study. Participants with seizures received topiramate as per Investigator's discretion were observed. | 1,232 |
| Total | 1,232 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 46 |
| Overall Study | Lack of Efficacy | 62 |
| Overall Study | Lost to Follow-up | 174 |
| Overall Study | Low compliance | 13 |
| Overall Study | Moved to other hospital | 10 |
| Overall Study | Other | 21 |
| Overall Study | tapering of topiramate | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Topiramate |
|---|---|
| Age Continuous | 24.07 Years STANDARD_DEVIATION 17.1 |
| Sex: Female, Male Female | 562 Participants |
| Sex: Female, Male Male | 670 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 34 / 1,234 |
| serious Total, serious adverse events | 8 / 1,234 |
Outcome results
Primary
Percentage of Participants Retained to Topiramate Treatment
Participants with long term retention of topiramate until 52 weeks were reported
Time frame: Week 52
Population: The full analysis set (FAS) population included all participants who met all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | Percentage of Participants Retained to Topiramate Treatment | 71.56 Percentage of participants |
Secondary
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
Population: FAS population included all participants who met all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) | 749 Participants |
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.
Time frame: Baseline up to Week 52
Population: FAS population included all participants who met all the eligibility criteria.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Topiramate | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | First Mono-therapy | 507 Participants | 0 |
| Topiramate | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Second Mono-therapy | 64 Participants | — |
| Topiramate | Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy | Add-on therapy | 661 Participants | — |
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.
Time frame: Baseline up to Week 52
Population: FAS population included all participants who met all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | Percentage of Participants Without Seizure | 40.50 Percentage of participants |
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.
Time frame: Week 52
Population: FAS population included all participants who met all the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topiramate | Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More | 84.20 Percentage of participants |