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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Epilepsy

Treatments: Drug: Topiramate

Study type: Observational

Funder types: Industry

Identifiers

NCT01682681

CR015865

TOPMATEPY4053

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,234 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,234 participants in 1 patient group

Topiramate

Treatment:

Drug: Topiramate