Clinical trial NCT01682681: An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
Official title: A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Topiramate
Topmax
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 1234
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include participants with epilepsy who visit an out-patient clinic for two months and have not received topiramate treatment for at least three months prior to Screening.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Retained to Topiramate Treatment
timeFrame: Week 52
Secondary outcomes:
measure: Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
timeFrame: Baseline up to Week 52
measure: Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy
timeFrame: Baseline up to Week 52
measure: Percentage of Participants Without Seizure
timeFrame: Baseline up to Week 52
measure: Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: