An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants 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: August 21, 2013
Last verified: August 2013
  Purpose

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


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:


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

Primary Outcome Measures:
  • Percentage of Participants Retained to Topiramate Treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Participants with long term retention of topiramate until 52 weeks were reported


Secondary Outcome Measures:
  • Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs) [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]
    Number of participants who received concomitant AEDs along with the topiramate were reported.

  • Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]
    Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.

  • Percentage of Participants Without Seizure [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: No ]
    Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.

  • Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.


Enrollment: 1234
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Topiramate Drug: Topiramate
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.

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

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 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.

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
  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
Study First Received: August 22, 2012
Results First Received: June 12, 2013
Last Updated: August 21, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Janssen Korea, Ltd., Korea:
Epilepsy
Topiramate
Topmax

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System 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 April 17, 2014