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

• Conditions: Epilepsy

• Registration Number: NCT02098941
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-25
• Last Update Submitted: 2014-03-25
• Study First Posted: 2014-03-28
• Last Update Posted: 2014-03-28
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention rate of topiramate, levetiracetam and oxcarbazepine during 24 months of treatment	24months	Overall retention rates of three treatment groups at two years will be presented in patient number (% of continuation or discontinuation).

Secondary Outcome Measures

Name	Time	Method
Evaluate the confounding factors affecting the retention rate	24 months	-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
Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)	24 months

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of