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

Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Topiramate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea


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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Percentage of Participants Retained to Topiramate Treatment

Secondary outcome:

Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)

Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy

Percentage of Participants Without Seizure

Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More

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.


Minimum age: 2 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: July 2007
Last updated: August 21, 2013

Page last updated: August 23, 2015

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