- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682681
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
August 21, 2013 updated by: Janssen Korea, Ltd., Korea
A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
1234
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Topiramate
|
This is an observational study.
Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Retained to Topiramate Treatment
Time Frame: Week 52
|
Participants with long term retention of topiramate until 52 weeks were reported
|
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
Time Frame: Baseline up to Week 52
|
Number of participants who received concomitant AEDs along with the topiramate were reported.
|
Baseline up to Week 52
|
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy
Time Frame: Baseline up to Week 52
|
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.
|
Baseline up to Week 52
|
Percentage of Participants Without Seizure
Time Frame: Baseline up to Week 52
|
Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.
|
Baseline up to Week 52
|
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
Time Frame: Week 52
|
Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
|
Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
August 22, 2012
First Submitted That Met QC Criteria
September 7, 2012
First Posted (Estimate)
September 11, 2012
Study Record Updates
Last Update Posted (Estimate)
September 6, 2013
Last Update Submitted That Met QC Criteria
August 21, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015865
- TOPMATEPY4053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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