EpilepsyNCT01682681
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy
An observational study of Epilepsy, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder). Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Topiramate
- How many people
- 1,234 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to May 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Topiramate
- Keywords
- Epilepsy, Topiramate, Topmax
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Not described Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Retained to Topiramate Treatment
Participants with long term retention of topiramate until 52 weeks were reported
Measured: Week 52
Secondary outcomes (4)
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
Number of participants who received concomitant AEDs along with the topiramate were reported.
Measured: Baseline up to Week 52
Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy
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.
Measured: Baseline up to Week 52
Percentage of Participants Without Seizure
Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.
Measured: Baseline up to Week 52
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682681
- Sponsor's protocol ID
- CR015865
- Other IDs
- TOPMATEPY4053
- Status last verified
- Aug 2013
- First submitted
- 22 Aug 2012
- Last updated
- 6 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multi-center Study to Assess Long-term Retention Rate of Topiramate in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT01682681
- Acronym / sponsor ID
- CR015865
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Topiramate, Topmax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 16 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term retention rate of topiramate in participants with epilepsy (seizure disorder).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate | – | Drug: Topiramate |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopiramateThis is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed. | Drug | Topiramate |
Primary outcome
Percentage of Participants Retained to Topiramate Treatment
Time frame: Week 52
Participants with long term retention of topiramate until 52 weeks were reported
4 secondary outcomes
Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)
Time frame: 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
Percentage of Participants Without Seizure
Time frame: Baseline up to Week 52
Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Retained to Topiramate Treatment (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.