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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682681
• Other study ID #: CR015865
• Secondary ID: TOPMATEPY4053
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2012
• Last updated: August 21, 2013
• Start date: July 2007
• Est. completion date: May 2009

Study information

• Verified date: August 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Topiramate
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Retained to Topiramate Treatment	Participants with long term retention of topiramate until 52 weeks were reported	Week 52	No
Secondary	Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)	Number of participants who received concomitant AEDs along with the topiramate were reported.	Baseline up to Week 52	No
Secondary	Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy	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	No
Secondary	Percentage of Participants Without Seizure	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	No
Secondary	Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More	Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.	Week 52	No