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

Completed

• Conditions: Epilepsy
• Interventions: Drug: Topiramate

• Registration Number: NCT01682681
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief 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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-11
• Results First Submitted: 2013-06-12
• Results First Submitted QC: 2013-06-12
• Status Verified: 2013-08
• Results First Posted: 2013-08-16
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1234

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Retained to Topiramate Treatment	Week 52	Participants with long term retention of topiramate until 52 weeks were reported

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)	Baseline up to Week 52	Number of participants who received concomitant AEDs along with the topiramate were reported.
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy	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.
Percentage of Participants Without Seizure	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.
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More	Week 52	Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.