A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen Korea, Ltd., Korea
- Enrollment
- 1,234
- Primary Endpoint
- Percentage of Participants Retained to Topiramate Treatment
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Topiramate
Intervention: Topiramate (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Retained to Topiramate Treatment
Time Frame: Week 52
Participants with long term retention of topiramate until 52 weeks were reported
Secondary Outcomes
- Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)(Baseline up to Week 52)
- Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy(Baseline up to Week 52)
- Percentage of Participants Without Seizure(Baseline up to Week 52)
- Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More(Week 52)