An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy|
- Percentage of Participants Retained to Topiramate Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]Participants with long term retention of topiramate until 52 weeks were reported
- Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
|Study Start Date:||July 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682681
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|