EpilepsyNCT02993861
Pharmacokinetics of Anti-epileptic Drugs in Obese Children
An observational study of Epilepsy and Obese, run by Christoph P Hornik, MD MPH at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- What is being tested?
- Anti-epileptics
- How many people
- 106 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Dec 2016to 17 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.
Who may be able to join
- 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
Who cannot join
- Known pregnancy as determined via interview or test results, if available
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30324
The Children's Hospital Colorado
Aurora, Colorado, 80045
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390-8589
Duke University Health System
Durham, North Carolina, 27705
University of Louisville Norton Childrens Hospital
Louisville, Kentucky, 40202
Oregon Health and Science University
Portland, Oregon
Nemours Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
Coastal Children's Services
Wilmington, North Carolina, 28401
About this study
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).
- Being tested
- Anti-epileptics
- Keywords
- Epilepsy, Obese
- Medical subject headings
- Epilepsy, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-epilepticsOther
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Children with epilepsy who are treated with levetiracetam per local standard of care Receives: Other: Anti-epileptics | |
| Valproic Acid | Children with epilepsy who are treated with valproic acid per local standard of care Receives: Other: Anti-epileptics | |
| Topiramate | Children with epilepsy who are treated with topiramate per local standard of care Receives: Other: Anti-epileptics | |
| Oxcarbazepine | Children with epilepsy who are treated with oxcarbazepine per local standard of care Receives: Other: Anti-epileptics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state pharmacokinetics area under the curve
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics maximum concentration
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics time to reach maximum concentration
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent volume of distribution
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics half life
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics oral apparent clearance
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Steady-state pharmacokinetics absorption rate constant
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Secondary outcomes (1)
Serious adverse events
Measured: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start9 Dec 2016
- Primary completion10 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph P Hornik, MD MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Christoph P Hornik, MD MPH, Duke University
- Investigators
- Kanecia Zimmerman, MD, MPH, Principal investigator, Duke Medical Center/Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993861
- Sponsor's protocol ID
- Pro00070924
- Status last verified
- Jun 2020
- First submitted
- 13 Dec 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sinha J, Zimmerman K, Balevic SJ, Hornik C, Muller WJ, Rathore M, Meyer M, Finkelstein Y, Al-Uzri A, Lakhotia A, Goldstein S, Chen JY, Anand R, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetic Modeling of Oxcarbazepine and Its Active Metabolite 10-Monohydroxy Derivative to Inform Dosing in Children with Obesity. Clin Pharmacokinet. 2026 Feb;65(2):329-344. doi: 10.1007/s40262-025-01579-0. Epub 2025 Nov 17.
PubMed 41247430
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Anti-epileptic Drugs in Obese Children
- ClinicalTrials.gov ID
- NCT02993861
- Acronym / sponsor ID
- Pro00070924
- Keywords
- Epilepsy, Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Christoph P Hornik, MD MPHUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | – | Other: Anti-epilepticsChildren with epilepsy who are treated with levetiracetam per local standard of care |
| Valproic Acid | – | Other: Anti-epilepticsChildren with epilepsy who are treated with valproic acid per local standard of care |
| Topiramate | – | Other: Anti-epilepticsChildren with epilepsy who are treated with topiramate per local standard of care |
| Oxcarbazepine | – | Other: Anti-epilepticsChildren with epilepsy who are treated with oxcarbazepine per local standard of care |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Known pregnancy as determined via interview or test results, if available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-epileptics | Other | Levetiracetam, Oxcarbazepine, Topiramate, Valproic Acid |
Primary outcome
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)
1 secondary outcome
Serious adverse events
Time frame: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 41247430Sinha J, Zimmerman K, Balevic SJ, Hornik C, Muller WJ, Rathore M, Meyer M, Finkelstein Y, Al-Uzri A, Lakhotia A, Goldstein S, Chen JY, Anand R, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetic Modeling of Oxcarbazepine and Its Active Metabolite 10-Monohydroxy Derivative to Inform Dosing in Children with Obesity. Clin Pharmacokinet. 2026 Feb;65(2):329-344. doi: 10.1007/s40262-025-01579-0. Epub 2025 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanecia Zimmerman, MD, MPH principal investigator
Duke Medical Center/Duke Clinical Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Obese, run by Christoph P Hornik, MD MPH at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.