Completed

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

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What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Brain Diseases+1

+ Central Nervous System Diseases

+ Nervous System Diseases

From 2 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2007
See protocol details

Summary

Principal SponsorJanssen Korea, Ltd., Korea
Last updated: September 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2007

Actual date on which the first participant was enrolled.

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.

NCT01682681
Principal SponsorJanssen Korea, Ltd., Korea
Last updated: September 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1234 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsy

Criteria

4 inclusion criteria required to participate
Female participants with child bearing potential and who use proper contraceptive methods during the study period
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
Participants with all type of epilepsy
Participants with more than 2 episodes of seizure during last 1 year
4 exclusion criteria prevent from participating
Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion
Participants who have known hypersensitivity reaction or allergy to the study drug
Participants who have taken topiramate within the three months of study start
Pregnant and nursing female participants

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers