Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Completed

Conditions studied: Epilepsy, Obese

In brief

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).

Key facts

Study ID

NCT02993861

Run by

Christoph P Hornik, MD MPH

People needed

106

Starts

2016-12-09

Expected to finish

2019-10-17

Last updated by the study team

2020-06-04

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known pregnancy as determined via interview or test results, if available

Where it is running

• The Children's Hospital Colorado — Aurora, Colorado, United States
• Nemours Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States
• Childrens Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Louisville Norton Childrens Hospital — Louisville, Kentucky, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Coastal Children's Services — Wilmington, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Texas Southwestern Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.