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OpenTrials
Completed

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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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital Colorado, Aurora, Colorado, United States

Loading trial locations.

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

Anti-epileptics

Other

Primary outcomes

  1. 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)

  2. Steady-state pharmacokinetics maximum concentration

    Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

  3. 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)

  4. 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)

  5. Steady-state pharmacokinetics half life

    Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

  6. Steady-state pharmacokinetics oral apparent clearance

    Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

  7. 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

  1. 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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