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

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ClinicalTrials.gov Identifier: NCT02098941
Recruitment Status : Unknown
Verified March 2014 by Sang Kun Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 28, 2014
Last Update Posted : March 28, 2014
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Sang Kun Lee, 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.

Condition or disease
Epilepsy

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

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Evaluate Retention Rate of Topiramate With That of Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Evaluate the confounding factors affecting the retention rate [ Time Frame: 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


  2. Evaluate the response rate through seizure reduction (≥75%, ≥50%) in 2-year treatment with each antiepileptic drugs (topiramate, levetiracetam, oxcarbazepine) [ Time Frame: 24 months ]

Other Outcome Measures:
  1. main reasons of drug discontinuation [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098941


Contacts
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Contact: Sang kun Lee, MD, PhD sangkun2923@gmail.com
Contact: Jung-won Shin, MD limitsum@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang kun Lee, MD,PhD       sangkun2923@gmail.com   
Contact: Jung-won Shin, MD       limitsum@gmail.com   
Principal Investigator: Sang kun Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Janssen Korea, Ltd., Korea
Investigators
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Principal Investigator: Sang Kun Lee, MD, PhD Seoul National University Hospital

Publications:
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Responsible Party: Sang Kun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02098941     History of Changes
Other Study ID Numbers: 0620133760
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014
Keywords provided by Sang Kun Lee, Seoul National University Hospital:
topiramate
oxcarbazepine
levetiracetam
retention rate
Additional relevant MeSH terms:
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Levetiracetam
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Oxcarbazepine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Nootropic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers