Clinical trial NCT02098941: Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
Official title: A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: topiramate
oxcarbazepine
levetiracetam
retention rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2014-03-28
Enrollment: 2500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who newly visited to epilepsy center in a tertiary hospital during January 1st 2006 to December 31st of 2010

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment
timeFrame: 24months
Secondary outcomes:
measure: Evaluate the confounding factors affecting the retention rate
timeFrame: 24 months
measure: Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)
timeFrame: 24 months
Other outcomes:
measure: main reasons of drug discontinuation
timeFrame: 24 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Kun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.