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

NCT ID: NCT01682681

Last Updated: 2013-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-05-31

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.

Conditions

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Epilepsy

Keywords

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Epilepsy Topiramate Topmax

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Topiramate

Topiramate

Intervention Type DRUG

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

Interventions

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Topiramate

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

Intervention Type DRUG

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

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TOPMATEPY4053

Identifier Type: -

Identifier Source: secondary_id

CR015865

Identifier Type: -

Identifier Source: org_study_id