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Pharmacokinetics of Anti-epileptic Drugs in Obese Children

NCT02993861 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2020-06-04

No results posted yet for this study

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).

Conditions

Interventions

OTHER

Anti-epileptics

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Christoph P Hornik, MD MPH

    lead OTHER

Principal Investigators

  • Kanecia Zimmerman, MD, MPH · Duke Medical Center/Duke Clinical Research Institute

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2019-10-10
Completion
2019-10-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02993861 on ClinicalTrials.gov