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

Janssen Korea, Ltd., Korea1,234 enrolled

Overview

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

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

1,234

Conditions

Epilepsy

Interventions

TopiramateDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Retained to Topiramate Treatment

Participants with long term retention of topiramate until 52 weeks were reported

Time frame: Week 52

Secondary Outcomes

Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)

Number of participants who received concomitant AEDs along with the topiramate were reported.

Time frame: Baseline up to Week 52

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.

Time frame: Baseline up to Week 52

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.

Time frame: Baseline up to Week 52

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.

Time frame: Week 52

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.