An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy

Epilepsy Clinical Trial

Official title: A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

• NCT number: NCT01682681
• Study type: Observational
• Source: Janssen Korea, Ltd., Korea
• Status: Completed
• Phase: Phase 4
• Start date: July 2007
• Completion date: May 2009