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

August 21, 2013 updated by: Janssen Korea, Ltd., Korea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants with epilepsy who visit an out-patient clinic for two months and have not received topiramate treatment for at least three months prior to Screening.

Description

Inclusion Criteria:

  • Participants with all type of epilepsy
  • Participants with more than 2 episodes of seizure during last 1 year
  • 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
  • Female participants with child bearing potential and who use proper contraceptive methods during the study period

Exclusion Criteria:

  • Participants who have known hypersensitivity reaction or allergy to the study drug
  • Participants who have taken topiramate within the three months of study start
  • Participants who are determined not to be suitable for the clinical study participation by an Investigator's discretion
  • Pregnant and nursing female participants

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Topiramate
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Retained to Topiramate Treatment
Time Frame: Week 52
Participants with long term retention of topiramate until 52 weeks were reported
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
Time Frame: Baseline up to Week 52
Number of participants who received concomitant AEDs along with the topiramate were reported.
Baseline up to Week 52
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy
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.
Baseline up to Week 52
Percentage of Participants Without Seizure
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.
Baseline up to Week 52
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
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.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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