EpilepsyNCT02098941
Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
An observational study of Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment. Read more about this study
- Who is it for?
- Ages 15 to 95 years
- Conditions the study is for
- Epilepsy
- How many people
- 2,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who newly visited to epilepsy center in a tertiary hospital during January 1st 2006 to December 31st of 2010
Who may be able to join
- Subjects who began their treatment with topiramate, levetiracetam or oxcarbazepine as mono or add-on therapy with conventional drugs.
- Subjects who are with partial or generalized epilepsy
Who cannot join
- Subjects who administered combination therapy in topiramate, levetiracetam or oxcarbazepine
- Subjects who have past experience of surgery for epilepsy treatment
- Subjects who were not followed up for at least 1 year
Trial locations and contacts
1 site in 1 country.
Sang kun Lee, MD, PhD contact
Jung-won Shin, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Sang kun Lee, MD,PhD, sangkun2923@gmail.com
Jung-won Shin, MD, limitsum@gmail.com
About this study
Official title: A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.
Read the detailed description
Primary objective The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.
Secondary objective The main secondary objective of this study is to evaluate confounding factors associated with retention rate of topiramate compared with other anticonvulsants.
- Baseline characteristics
- Seizure Type
- Gender
- Age of onset
- Treatment regimen
- Number of concomitant medication
- Type of drug combination
- Final target dose
- Titration speed
Other secondary objectives
The other secondary objectives of this study are to compare followings by each medication:
- Rate of seizure reduction (≥75%, ≥50%)
- Rate of seizure freedom
- Conditions
- Epilepsy
- Keywords
- topiramate, oxcarbazepine, levetiracetam, retention rate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with topiramate as mono or add-on therapy with conventional drugs. | |
| Levetiracetam | Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with levetiracetam as mono or add-on therapy with conventional drugs. | |
| Oxcarbazepine | Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with oxcarbazepine as mono or add-on therapy with conventional drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment
Overall retention rates of three treatment groups at two years will be presented in patient number (% of continuation or discontinuation).
Measured: 24months
Secondary outcomes (2)
Evaluate the confounding factors affecting the retention rate
-Confounding factors associated with retention rate
: Seizure Type, gender, age, treatment regimen, number of concomitant medication, type of drug combination, final target dose, titration speed
Measured: 24 months
Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Sang Kun Lee, Seoul National University Hospital
- Investigators
- Sang Kun Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098941
- Sponsor's protocol ID
- 0620133760
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramsay E, Faught E, Krumholz A, Naritoku D, Privitera M, Schwarzman L, Mao L, Wiegand F, Hulihan J; CAPSS-272 Study Group. Efficacy, tolerability, and safety of rapid initiation of topiramate versus phenytoin in patients with new-onset epilepsy: a randomized double-blind clinical trial. Epilepsia. 2010 Oct;51(10):1970-7. doi: 10.1111/j.1528-1167.2010.02670.x.
PubMed 20633037Peltola J, Peltola M, Auvinen A, Raitanen J, Fallah M, Keranen T. Retention rates of new antiepileptic drugs in localization-related epilepsy: a single-center study. Acta Neurol Scand. 2009 Jan;119(1):55-60. doi: 10.1111/j.1600-0404.2008.01062.x. Epub 2008 Jun 24.
PubMed 18616622
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
- ClinicalTrials.gov ID
- NCT02098941
- Acronym / sponsor ID
- 0620133760
- Conditions
- Epilepsy
- Keywords
- topiramate, oxcarbazepine, levetiracetam, retention rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.
Detailed description
Primary objective The Objective of this study is to compare 2-year retention rate of topiramate, levetiracetam and oxcarbazepine in a long term epilepsy treatment.
Secondary objective The main secondary objective of this study is to evaluate confounding factors associated with retention rate of topiramate compared with other anticonvulsants.
- Baseline characteristics
- Seizure Type
- Gender
- Age of onset
- Treatment regimen
- Number of concomitant medication
- Type of drug combination
- Final target dose
- Titration speed
Other secondary objectives
The other secondary objectives of this study are to compare followings by each medication:
- Rate of seizure reduction (≥75%, ≥50%)
- Rate of seizure freedom
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topiramate | – | –Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with topiramate as mono or add-on therapy with conventional drugs. |
| Levetiracetam | – | –Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with levetiracetam as mono or add-on therapy with conventional drugs. |
| Oxcarbazepine | – | –Subjects who newly visited to the investigator institution during January 1st 2006 to December 31st of 2010 and began their treatment with oxcarbazepine as mono or add-on therapy with conventional drugs. |
Who may qualify
- Ages
- 15 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who newly visited to epilepsy center in a tertiary hospital during January 1st 2006 to December 31st of 2010
Key inclusion criteria (2 listed)
- Subjects who began their treatment with topiramate, levetiracetam or oxcarbazepine as mono or add-on therapy with conventional drugs.
- Subjects who are with partial or generalized epilepsy
Key exclusion criteria (3 listed)
- Subjects who administered combination therapy in topiramate, levetiracetam or oxcarbazepine
- Subjects who have past experience of surgery for epilepsy treatment
- Subjects who were not followed up for at least 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment
Time frame: 24months
Overall retention rates of three treatment groups at two years will be presented in patient number (% of continuation or discontinuation).
2 secondary outcomes
Evaluate the confounding factors affecting the retention rate
Time frame: 24 months
Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
- Background: PubMed 20633037Ramsay E, Faught E, Krumholz A, Naritoku D, Privitera M, Schwarzman L, Mao L, Wiegand F, Hulihan J; CAPSS-272 Study Group. Efficacy, tolerability, and safety of rapid initiation of topiramate versus phenytoin in patients with new-onset epilepsy: a randomized double-blind clinical trial. Epilepsia. 2010 Oct;51(10):1970-7. doi: 10.1111/j.1528-1167.2010.02670.x.
- Background: PubMed 18616622Peltola J, Peltola M, Auvinen A, Raitanen J, Fallah M, Keranen T. Retention rates of new antiepileptic drugs in localization-related epilepsy: a single-center study. Acta Neurol Scand. 2009 Jan;119(1):55-60. doi: 10.1111/j.1600-0404.2008.01062.x. Epub 2008 Jun 24.
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Epilepsy
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.
Sang kun Lee, MD, PhD contact
Jung-won Shin, MD contact
Sang Kun Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Seoul National University Hospital at 1 site in South 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang kun Lee, MD, PhD (sangkun2923@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098941, which also lists 2 linked publications.
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 28 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.