Clinical trial NCT02993861: Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Official title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Obese
Keywords: Epilepsy
Obese
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The Emmes Company, LLC
First posted: 2016-12-15
Enrollment: 106
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Steady-state pharmacokinetics area under the curve
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics maximum concentration
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics time to reach maximum concentration
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics oral apparent volume of distribution
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics half life
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics oral apparent clearance
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
measure: Steady-state pharmacokinetics absorption rate constant
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Secondary outcomes:
measure: Serious adverse events
timeFrame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours Alfred I. DuPont Hospital for Children
state: Delaware
city: Atlanta
country: United States
facility: Childrens Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Norton Childrens Hospital
state: Kentucky
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Children's Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Dallas
state: Texas
Study officials:
affiliation: Duke Medical Center/Duke Clinical Research Institute
name: Kanecia Zimmerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: