Pharmacokinetics of Anti-epileptic Drugs in Obese Children



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:2 - 18
Updated:12/29/2018
Start Date:December 9, 2016
End Date:September 2019
Contact:Kanecia Zimmerman, MD, MPH
Email:kanecia.obie@dm.duke.edu
Phone:919-668-8651

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The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to
characterize the pharmacokinetics and safety of four oral anti-epileptics drugs
(levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if
inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese
children and adolescents. The study's duration will be up to eleven days (up to seven days of
screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18
years will be identified through outpatient clinic schedules and inpatient admissions at each
clinic site. Participants receiving at least one of the study drugs per local standard of
care will have pharmacokinetic concentrations in plasma drawn according to the specific
dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip
ratio, medical history, concomitant medication history, documentation of study drug oral
intake, adverse effects, and physical examination. The sample size will include 24
participants for each anti-epileptic drug (total 96).


Inclusion Criteria:

- 2 years to < 18 years at the time of enrollment

- BMI ≥ 95th percentile for age and sex, based on CDC recommendations

- Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)

- Receiving ≥ 1 of the study drugs per local standard of care

Exclusion Criteria:

- Known pregnancy as determined via interview or test results, if available
We found this trial at
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sites
Chapel Hill, North Carolina 27599
(919) 962-2211
Phone: 919-966-9051
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Phone: 214-456-8242
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-2797
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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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Phone: 404-785-8798
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Phone: 720-777-4719
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-6280
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Durham, North Carolina
Phone: 919-684-4627
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231 East Chestnut Street
Louisville, Kentucky 40202
Phone: 502-629-4697
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Louisville, KY
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Wilmington, Delaware 19803
Phone: 302-298-7521
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Wilmington, DE
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Wilmington, North Carolina 28401
Phone: 910-667-5483
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