Topiramate
DrugThis is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
NCT Number: NCT01682681
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
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Notify Me2 year–65 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
Time frame: Week 52
Participants with long term retention of topiramate until 52 weeks were reported
Time frame: Baseline up to Week 52
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 (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
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: Week 52
Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
Janssen Korea, Ltd., Korea
Industry
A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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