Last updated on May 2019

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Brief description of study

The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

Detailed Study Description

This is a randomized (study medication assigned to participants by chance), open-label, multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study of topiramate compared with 1 another AED (levetiracetam) in pediatric participants with epilepsy. The total study duration will be up to of 1 year and 2 months per participant. The study consists of 3 parts: Screening (that is, up to 35 days before study commences on Day 1); Treatment (1 year) and post-treatment (30 days). Safety will primarily be evaluated by percentage of participants with kidney stones and change from baseline in bone mineral density at Month 12.

Clinical Study Identifier: NCT02201251

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Center for Neurosciences

Tucson, AZ United States
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Childrens Hospital Los Angeles

Los Angeles, CA United States
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Los Angeles, CA United States
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Pediatric Neurology, Pa

Orlando, FL United States
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Georgia Regents University

Augusta, GA United States
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UNC Chapel Hill

Chapel Hill, NC United States
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Duke University

Durham, NC United States
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Vanderbilt Children's Hospital

Nashville, TN United States
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Road Runner Research, Ltd.

San Antonio, TX United States
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Scott & White Clinic

Temple, TX United States
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Seattle Children's Hospital

Seattle, WA United States
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Hospital Fleni

Buenos Aires, Argentina
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Hospital De Ni os Sor Maria Ludovica

La Plata, Buenos Aires, Argentina
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Dr. Kenessey A. Hospital

Balassagyarmat, Hungary
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Monterrey, Mexico
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MHCI Clinical Hospital No 8

Yaroslavl, Russian Federation
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Parklands Hospital

Durban, South Africa
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Recruitment Status: Open

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