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

Epilepsy Clinical Trial

Official title:

A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02098941
• Other study ID #: 0620133760
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 25, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Seoul National University Hospital
• Contact: Sang kun Lee, MD, PhD
• Email: sangkun2923[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 95 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Peltola J, Peltola M, Auvinen A, Raitanen J, Fallah M, Keränen 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	main reasons of drug discontinuation		24 months	Yes
Primary	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).	24months	No
Secondary	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	24 months	Yes
Secondary	Evaluate the response rate through seizure reduction (=75%, =50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine)		24 months	Yes