Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Epilepsy Clinical Trial

Official title:

Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993861
• Other study ID #: Pro00070924
• Status: Completed
• Start date: December 9, 2016
• Est. completion date: October 17, 2019

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 17, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Obese

Intervention

Other:
• Anti-epileptics

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Christoph P Hornik, MD MPH	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady-state pharmacokinetics area under the curve		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics maximum concentration		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics time to reach maximum concentration		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics oral apparent volume of distribution		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics half life		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics oral apparent clearance		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Primary	Steady-state pharmacokinetics absorption rate constant		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Secondary	Serious adverse events		Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)