Pharmacokinetics of Anti-epileptic Drugs in Obese Children

• Sponsor: Christoph P Hornik, MD MPH (Other)
• Overall Status: Completed
• CT.gov ID: NCT02993861
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), The Emmes Company, LLC (Industry)
• Enrollment: 106
• Locations: 10
• Actual Duration (Months): 34.2
• Patients Per Site: 10.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Obese	Other: Anti-epileptics

Study Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children
• Actual Study Start Date: Dec 9, 2016
• Actual Primary Completion Date: Oct 10, 2019
• Actual Study Completion Date: Oct 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Levetiracetam Children with epilepsy who are treated with levetiracetam per local standard of care	Other: Anti-epileptics
Valproic Acid Children with epilepsy who are treated with valproic acid per local standard of care	Other: Anti-epileptics
Topiramate Children with epilepsy who are treated with topiramate per local standard of care	Other: Anti-epileptics
Oxcarbazepine Children with epilepsy who are treated with oxcarbazepine per local standard of care	Other: Anti-epileptics

Outcome Measures

Primary Outcome Measures

1. Steady-state pharmacokinetics area under the curve [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

2. Steady-state pharmacokinetics maximum concentration [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 [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 [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

5. Steady-state pharmacokinetics half life [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

6. Steady-state pharmacokinetics oral apparent clearance [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

7. Steady-state pharmacokinetics absorption rate constant [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

Secondary Outcome Measures

1. Serious adverse events [Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital Colorado	Aurora	Colorado	United States	80045
2	Nemours Alfred I. DuPont Hospital for Children	Wilmington	Delaware	United States	19803
3	Childrens Healthcare of Atlanta	Atlanta	Georgia	United States	30324
4	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
5	University of Louisville Norton Childrens Hospital	Louisville	Kentucky	United States	40202
6	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
7	Duke University Health System	Durham	North Carolina	United States	27705
8	Coastal Children's Services	Wilmington	North Carolina	United States	28401
9	Oregon Health and Science University	Portland	Oregon	United States
10	University of Texas Southwestern Medical Center Dallas	Dallas	Texas	United States	75390-8589

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kanecia Zimmerman, MD, MPH, Duke Medical Center/Duke Clinical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christoph P Hornik, MD MPH, Associate Professor of Pediatrics, Duke University
• ClinicalTrials.gov Identifier: NCT02993861
• Other Study ID Numbers: Pro00070924
• First Posted: Dec 15, 2016
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Christoph P Hornik, MD MPH, Associate Professor of Pediatrics, Duke University: Epilepsy; Obese
• Additional relevant MeSH terms: Epilepsy; Anticonvulsants

Study Results

No Results Posted as of Jun 4, 2020