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A Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01682681
First received: August 22, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to assess the long-term retention rate of topiramate therapy in patients with epilepsy.


Condition Intervention Phase
Epilepsy
 Drug: Topiramate
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
Drug Information available for: Topiramate
U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • The retention rate of topiramate at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of concomitant new antiepileptic drugs (AEDs), as a predictor that can influence retention [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • The daily dose of topiramate, as a predictor that can influence retention [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Reason for discontinuation of topiramate treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    One of the following criteria will be chosen as the reason for discontinuation: lack of efficacy; adverse events; no follow-up visit; well controlled symptoms; low compliance to medication; or other reasons.

  • Seizure free rate at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 1238
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Topiramate Drug: Topiramate
Patients will receive flexible dose of topiramate, according to the patient's individual prescription, administered orally twice daily.

Detailed Description:

This is a prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), observational and multi-center study. The study population will be all types of outpatients with epilepsy visiting each study center participating in this study over a period of two months.

  Eligibility

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be all types of outpatients with epilepsy visiting each study center participating in this study for two months.

Criteria

Inclusion Criteria:

  • All types of epileptic patients
  • Patients have at least 2 seizure episodes for the last 1 year
  • Patients must have signed an informed consent

Exclusion Criteria:

  • Patients who have known hypersensitivity reaction or allergy to the study drug
  • Patients who are determined not to be suitable for the clinical study participation by an investigator's discretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682681

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01682681     History of Changes
Other Study ID Numbers: CR015865, TOPMATEPY4053, TOP-KOR-037
Study First Received: August 22, 2012
Last Updated: September 7, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Janssen Korea, Ltd., Korea:
Epilepsy
Topiramate
Retention Rate

Additional relevant MeSH terms:
Epilepsy
Urinary Retention
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Urination Disorders
Urologic Diseases
Topiramate
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on May 16, 2013