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Pharmacokinetics of Anti-epileptic Drugs in Obese Children

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ClinicalTrials.gov Identifier: NCT02993861
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
Information provided by (Responsible Party):
Duke University

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
Epilepsy Obese Other: Anti-epileptics

Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort 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



Primary Outcome Measures :
  1. Steady-state pharmacokinetics area under the curve [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  2. Steady-state pharmacokinetics maximum concentration [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  3. Steady-state pharmacokinetics time to reach maximum concentration [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  4. Steady-state pharmacokinetics oral apparent volume of distribution [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  5. Steady-state pharmacokinetics half life [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  6. Steady-state pharmacokinetics oral apparent clearance [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]
  7. Steady-state pharmacokinetics absorption rate constant [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]

Secondary Outcome Measures :
  1. Serious adverse events [ Time Frame: Up to 11 days (up to 7 days of screening and 4 days of pharmacokinetic sampling) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993861


Contacts
Contact: Kanecia Zimmerman, MD, MPH 919-668-8651 kanecia.obie@dm.duke.edu
Contact: Barrie Harper 919-668-8291 barrie.harper@duke.edu

Locations
United States, Colorado
The Children's Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Austin Drake    720-777-4719    austin.drake@childrenscolorado.org   
Contact: Charuta Joshi, MD    1-720-777-6895    charuta.joshi@childrenscolorado.org   
United States, Delaware
Nemours Alfred I. DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Ramany John    302-298-7521    ramany.john@nemours.org   
Contact: Marisa Meyer, MD    1-302-651-4021    marisa.meyer@nemours.org   
United States, Georgia
Childrens Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30324
Contact: Sims Christopher    404-785-8798    christopher.sims@choa.org   
Contact: Ton DeGrauw, MD    1-404-785-4446    ton.degrauw@choa.org   
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Laura Fearn    312-227-6280    lfearn@luriechildrens.org   
Contact: William Muller, MD    312-503-3218    wjmuller@northwestern.edu   
United States, Kentucky
University of Louisville Norton Childrens Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Terri Simeon    502-629-5820    theresa.simeon@louisville.edu   
Contact: Arpita Lakhotia, MD    1-502-629-5820    arpita.lakhotia@louisville.edu   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Shradhdha Joshi    919-966-9051    snjoshi@neurology.unc.edu   
Contact: Yael Shiloh-Malawsky, MD    919-966-2922    yaelm@neurology.unc.edu   
Duke University Health System Recruiting
Durham, North Carolina, United States, 27705
Contact: Kanecia Zimmerman, MD    919-668-8651    kanecia.obie@dm.duke.edu   
Contact: Harward Melissa    919-668-3910    melissa.harward@dm.duke.edu   
Coastal Children's Services Not yet recruiting
Wilmington, North Carolina, United States, 28401
Contact: Arielle Lapid    910-667-5483    arielle.lapid@ccneo.net   
Contact: Sasidharan Taravath, MD    1-910-667-5165    sasi.taravath@coastalchildrensservices.net   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States
Contact: Kira Clark    503-418-8112    clarki@ohsu.edu   
Contact: Amira Al-Uzri    1-503-494-6956    aluzria@ohsu.edu   
United States, Texas
University of Texas Southwestern Medical Center Dallas Recruiting
Dallas, Texas, United States, 75390-8589
Contact: Susan Arnold, MD    214-456-8242    susan.arnold@utsouthwestern.edu   
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Megan Kelton    206-987-5539    megan.kelton@seattlechildrens.org   
Contact: Joseph Flynn, MD    1-206-987-2524    joseph.flynn@seattlechildrens.org   
Sponsors and Collaborators
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02993861     History of Changes
Other Study ID Numbers: Pro00070924
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

Keywords provided by Duke University:
Epilepsy
Obese

Additional relevant MeSH terms:
Anticonvulsants
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers