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



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:2 - 15
Updated:3/27/2019
Start Date:October 6, 2014
End Date:May 31, 2022
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

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.

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.

Inclusion Criteria:

- Participant with a clinical diagnosis of new-onset or recent-onset epilepsy
characterized by partial-onset seizures (POS) (with or without secondary
generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance
with criteria of the International League Against Epilepsy. The epilepsy diagnosis
must be within the previous 2 years before screening

- Caregivers (parents or legally acceptable representatives) of the participant must be
able to accurately maintain the participant take-home record and seizure diary

- At screening, participant must have weight and height values within the 5th to 95th
percentile for chronological age (based on standard Child Height and Weight Charts
from the Centers for Disease Control [CDC])

- Participant must never have been treated for epilepsy (treatment-naïve) or have been
treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent
AED use was necessary. Previous AED exposure must not exceed either of the following:
1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of
previous AED exposure in the past if the AED has been discontinued for at least 1 year
prior to enrollment

- Parents (or legally acceptable representatives) of the participant must sign an
informed consent/permission document, indicating that they understand the purpose of
and procedures required for the study and are willing to give permission for their
child to participate in the study. Participant 7 years of age and older, capable of
understanding the nature of the study, must provide assent for their participation

Exclusion Criteria:

- Participant has a surgically implanted and functioning vagus nerve stimulator

- Participant has a history of seizures as a result of a correctable medical condition,
such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2
weeks prior to the first day of Screening

- Participant has had uncontrolled seizures while previously taking either topiramate or
levetiracetam

- Participant has a history of non-epileptic seizures within 2 weeks prior to the first
day of Screening

- Participant has myoclonic or absence seizures
We found this trial at
28
sites
Gulf Breeze, Florida 32561
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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7485 Sandlake Commons Blvd.
Orlando, Florida 32835
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Orlando, FL
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Tucson, AZ
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Augusta, GA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Buenos Aires,
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CHapel Hill, North Carolina 27599
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CHapel Hill, NC
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700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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7046 Southwest Archer Road
Gainesville, Florida 32608
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Gainesville, FL
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Iowa City, IA
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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401 East Chestnut Street
Louisville, Kentucky 40202
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Louisville, KY
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Madison, Wisconsin 53715
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Madison, WI
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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San Antonio, Texas 78258
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San Antonio, TX
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Tampa, FL
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Temple, Texas 76508
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Temple, TX
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Toledo, OH
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Valhalla, New York 10595
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Valhalla, NY
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12794 Forest Hill Boulevard
Wellington, Florida 33414
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Wellington, FL
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