NCT Number: NCT02993861
Pharmacokinetics of Anti-epileptic Drugs in Obese Children
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).
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Notify MeKey information
Conditions
Age range
2 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
The Children's Hospital Colorado, Aurora, Colorado, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Steady-state pharmacokinetics area under the curve
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics maximum concentration
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics time to reach maximum concentration
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics oral apparent volume of distribution
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics half life
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics oral apparent clearance
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
-
Steady-state pharmacokinetics absorption rate constant
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Secondary outcomes
-
Serious adverse events
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Sponsors and collaborators
Lead sponsor
Christoph P Hornik, MD MPH
Other
Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- The Emmes Company, LLC
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Dec 15, 2016
- Registry last updated
- Jun 4, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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