Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment

NCT ID: NCT02098941

Last Updated: 2014-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

1. Baseline characteristics

* Seizure Type
* Gender
* Age of onset
2. 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

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Kun Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Kun Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang kun Lee, MD, PhD

Role: CONTACT

Jung-won Shin, MD

Role: CONTACT

Facility Contacts

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Sang kun Lee, MD,PhD

Role: primary

Jung-won Shin, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 20633037 (View on PubMed)

Peltola 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.

Reference Type BACKGROUND
PMID: 18616622 (View on PubMed)

Other Identifiers

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0620133760

Identifier Type: -

Identifier Source: org_study_id

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