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

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

Detailed Description
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Topiramate<br> | Drug: Topiramate<br>* This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Retained to Topiramate Treatment | 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) | 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 | 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 | 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 | Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported. | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Topiramate, Topmax