NCT01682681

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,234 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Topiramate	This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2012-09-11
• Last updated: 2013-09-06
• Results posted: 2013-08-16